Trial Outcomes & Findings for Comparison of the Effect of Preoperative and Postoperative ESP and PVB on Postoperative Pain in VATS (NCT NCT06488014)
NCT ID: NCT06488014
Last Updated: 2026-05-15
Results Overview
Pain severity was assessed using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
72 hours
Results posted on
2026-05-15
Participant Flow
A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
Participant milestones
| Measure |
Group E
After the study was initiated, patients were allocated to groups according to their chronological order of surgery as follows:
E ARM (ESP Group):
Patients numbered 1, 3, 4, 6, 8, 10, 14, 15, 17, 18, 22, 23, 24, 27, 28, 29, 32, 33, 36, 38, 44, 45, 46, 47, 53, 54, 55, 56, 57, 58, 61, 64, 65, 68, 70, 72, 73, 76, 77 and 80 in the surgical sequence were assigned to the ESP group.
Erector spina plan block : Under USG guidance, local anaesthetic will be administered to the fascial plane between the erector spinae muscle and the transverse process.
Erector spina plan block (ESP): In both groups, the relevant methods will be applied at the level of the surgical incision before the surgical incision (pre-emptive) after the patient is asleep and before the patient wakes up at the end of surgery.
The dose of local anaesthetic to be administered is the same for both groups.
Drug content to be administered\*: total 25 cc volume (13.5 ml 0.5% bupivacaine + 5 ml 2% lidocaine + 1.5 ml morphine (morphine diluted with 0.9% NaCl to 1mg/ml) + 5 ml 0.9% NaCl) (These doses are the routine doses applied in such surgeries in our clinic)
\* Local anaesthetic drug doses in regional anaesthesia: source: Kirk, P. H. I. I. L. I. I. P. P., \& Berde, C. B. (2020). Local anaesthetics. Miller's Anaesthesia. 9th ed. Philadelphia: Elsevier Inc, 878-9.
|
Group P
After the study was initiated, patients were allocated to groups according to their chronological order of surgery as follows:
P ARM (Paravertebral Group):
Patients numbered 2, 5, 7, 9, 11, 12, 13, 16, 19, 20, 21, 25, 26, 30, 31, 34, 35, 37, 39, 40, 41, 42, 43, 48, 49, 50, 51, 52, 59, 60, 62, 63, 66, 67, 69, 71, 74, 75, 78 and 79 in the surgical sequence were assigned to the Paravertebral group.
Paravertebral block: USG-guided local anaesthetic administration to the side of the vertebral body close to where the spinal nerves exit from the intervertebral foramen.
Paravertebral block: In both groups, the relevant methods will be applied at the level of the surgical incision before the surgical incision (pre-emptive) after the patient is asleep and before the patient wakes up at the end of surgery.
The dose of local anaesthetic to be administered is the same for both groups.
Drug content to be administered\*: total 25 cc volume (13.5 ml 0.5% bupivacaine + 5 ml 2% lidocaine + 1.5 ml morphine (morphine diluted with 0.9% NaCl to 1mg/ml) + 5 ml 0.9% NaCl) (These doses are the routine doses applied in such surgeries in our clinic)
\* Local anaesthetic drug doses in regional anaesthesia: source: Kirk, P. H. I. I. L. I. I. P. P., \& Berde, C. B. (2020). Local anaesthetics. Miller's Anaesthesia. 9th ed. Philadelphia: Elsevier Inc, 878-9.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
Baseline characteristics by cohort
| Measure |
Group E
n=40 Participants
After the study was initiated, patients were allocated to groups according to their chronological order of surgery as follows:
E ARM (ESP Group):
Patients numbered 1, 3, 4, 6, 8, 10, 14, 15, 17, 18, 22, 23, 24, 27, 28, 29, 32, 33, 36, 38, 44, 45, 46, 47, 53, 54, 55, 56, 57, 58, 61, 64, 65, 68, 70, 72, 73, 76, 77 and 80 in the surgical sequence were assigned to the ESP group.
Erector spina plan block : Under USG guidance, local anaesthetic will be administered to the fascial plane between the erector spinae muscle and the transverse process.
Erector spina plan block (ESP): In both groups, the relevant methods will be applied at the level of the surgical incision before the surgical incision (pre-emptive) after the patient is asleep and before the patient wakes up at the end of surgery.
The dose of local anaesthetic to be administered is the same for both groups.
Drug content to be administered\*: total 25 cc volume (13.5 ml 0.5% bupivacaine + 5 ml 2% lidocaine + 1.5 ml morphine (morphine diluted with 0.9% NaCl to 1mg/ml) + 5 ml 0.9% NaCl) (These doses are the routine doses applied in such surgeries in our clinic)
\* Local anaesthetic drug doses in regional anaesthesia: source: Kirk, P. H. I. I. L. I. I. P. P., \& Berde, C. B. (2020). Local anaesthetics. Miller's Anaesthesia. 9th ed. Philadelphia: Elsevier Inc, 878-9.
|
Group P
n=37 Participants
After the study was initiated, patients were allocated to groups according to their chronological order of surgery as follows:
P ARM (Paravertebral Group):
Patients numbered 2, 5, 7, 9, 11, 12, 13, 16, 19, 20, 21, 25, 26, 30, 31, 34, 35, 37, 39, 40, 41, 42, 43, 48, 49, 50, 51, 52, 59, 60, 62, 63, 66, 67, 69, 71, 74, 75, 78 and 79 in the surgical sequence were assigned to the Paravertebral group.
Paravertebral block: USG-guided local anaesthetic administration to the side of the vertebral body close to where the spinal nerves exit from the intervertebral foramen.
Paravertebral block: In both groups, the relevant methods will be applied at the level of the surgical incision before the surgical incision (pre-emptive) after the patient is asleep and before the patient wakes up at the end of surgery.
The dose of local anaesthetic to be administered is the same for both groups.
Drug content to be administered\*: total 25 cc volume (13.5 ml 0.5% bupivacaine + 5 ml 2% lidocaine + 1.5 ml morphine (morphine diluted with 0.9% NaCl to 1mg/ml) + 5 ml 0.9% NaCl) (These doses are the routine doses applied in such surgeries in our clinic)
\* Local anaesthetic drug doses in regional anaesthesia: source: Kirk, P. H. I. I. L. I. I. P. P., \& Berde, C. B. (2020). Local anaesthetics. Miller's Anaesthesia. 9th ed. Philadelphia: Elsevier Inc, 878-9.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=40 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
63 years
n=37 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
62 years
n=77 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
|
Sex: Female, Male
Female
|
22 Participants
n=40 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
22 Participants
n=37 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
44 Participants
n=77 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
|
Sex: Female, Male
Male
|
18 Participants
n=40 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
15 Participants
n=37 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
33 Participants
n=77 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Height
|
168.9 cm
STANDARD_DEVIATION 9.9 • n=40 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
160.7 cm
STANDARD_DEVIATION 9.4 • n=37 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
166 cm
STANDARD_DEVIATION 9.9 • n=77 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
|
BMI
|
26.6 kg/m2
STANDARD_DEVIATION 4.6 • n=40 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
27 kg/m2
STANDARD_DEVIATION 4.1 • n=37 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
26.8 kg/m2
STANDARD_DEVIATION 4.3 • n=77 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
|
Smoking
|
0 pack/years
n=40 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
4 pack/years
n=37 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
0 pack/years
n=77 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
|
Surgical duration
|
180 minute
n=40 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
180 minute
n=37 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
180 minute
n=77 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
|
Muscle relaxant dose (intraoperative)
|
107 mg
STANDARD_DEVIATION 27 • n=40 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
106 mg
STANDARD_DEVIATION 29 • n=37 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
107 mg
STANDARD_DEVIATION 27.6 • n=77 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
|
Total fentanyl amount (intraoperative)
|
150 mcg
n=40 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
150 mcg
n=37 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
150 mcg
n=77 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
|
Time of chest tube removal
|
3 days
n=40 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
3 days
n=37 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
3 days
n=77 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
|
Postoperative mobilisation time
|
8 hours
n=40 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
8 hours
n=37 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
8 hours
n=77 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
|
ICU stay duration
|
1 days
n=40 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
1 days
n=37 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
1 days
n=77 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
|
Hospital stay duration
|
5 days
n=40 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
5 days
n=37 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
5 days
n=77 Participants • A total of 80 patients were assessed for eligibility. All eligible patients were allocated according to the pre-determined chronological order based on surgery dates. Forty patients were assigned to the ESPB group and 40 patients to the PVB group. In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
|
PRIMARY outcome
Timeframe: 72 hoursPain severity was assessed using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Outcome measures
| Measure |
Group E
n=40 Participants
After the study was initiated, patients were allocated to groups according to their chronological order of surgery as follows:
E ARM (ESP Group):
Patients numbered 1, 3, 4, 6, 8, 10, 14, 15, 17, 18, 22, 23, 24, 27, 28, 29, 32, 33, 36, 38, 44, 45, 46, 47, 53, 54, 55, 56, 57, 58, 61, 64, 65, 68, 70, 72, 73, 76, 77 and 80 in the surgical sequence were assigned to the ESP group.
Erector spina plan block : Under USG guidance, local anaesthetic will be administered to the fascial plane between the erector spinae muscle and the transverse process.
Erector spina plan block (ESP): In both groups, the relevant methods will be applied at the level of the surgical incision before the surgical incision (pre-emptive) after the patient is asleep and before the patient wakes up at the end of surgery.
The dose of local anaesthetic to be administered is the same for both groups.
Drug content to be administered\*: total 25 cc volume (13.5 ml 0.5% bupivacaine + 5 ml 2% lidocaine + 1.5 ml morphine (morphine diluted with 0.9% NaCl to 1mg/ml) + 5 ml 0.9% NaCl) (These doses are the routine doses applied in such surgeries in our clinic)
\* Local anaesthetic drug doses in regional anaesthesia: source: Kirk, P. H. I. I. L. I. I. P. P., \& Berde, C. B. (2020). Local anaesthetics. Miller's Anaesthesia. 9th ed. Philadelphia: Elsevier Inc, 878-9.
|
Group P
n=37 Participants
After the study was initiated, patients were allocated to groups according to their chronological order of surgery as follows:
P ARM (Paravertebral Group):
Patients numbered 2, 5, 7, 9, 11, 12, 13, 16, 19, 20, 21, 25, 26, 30, 31, 34, 35, 37, 39, 40, 41, 42, 43, 48, 49, 50, 51, 52, 59, 60, 62, 63, 66, 67, 69, 71, 74, 75, 78 and 79 in the surgical sequence were assigned to the Paravertebral group.
Paravertebral block: USG-guided local anaesthetic administration to the side of the vertebral body close to where the spinal nerves exit from the intervertebral foramen.
Paravertebral block: In both groups, the relevant methods will be applied at the level of the surgical incision before the surgical incision (pre-emptive) after the patient is asleep and before the patient wakes up at the end of surgery.
The dose of local anaesthetic to be administered is the same for both groups.
Drug content to be administered\*: total 25 cc volume (13.5 ml 0.5% bupivacaine + 5 ml 2% lidocaine + 1.5 ml morphine (morphine diluted with 0.9% NaCl to 1mg/ml) + 5 ml 0.9% NaCl) (These doses are the routine doses applied in such surgeries in our clinic)
\* Local anaesthetic drug doses in regional anaesthesia: source: Kirk, P. H. I. I. L. I. I. P. P., \& Berde, C. B. (2020). Local anaesthetics. Miller's Anaesthesia. 9th ed. Philadelphia: Elsevier Inc, 878-9.
|
|---|---|---|
|
Acute Postoperative Pain (With NRS )
with movement - 72 hour
|
2 NRS score
Interval 0.0 to 4.0
|
3 NRS score
Interval 2.0 to 5.0
|
|
Acute Postoperative Pain (With NRS )
with coughing - 20 minute
|
5 NRS score
Interval 4.0 to 8.0
|
5 NRS score
Interval 0.0 to 7.0
|
|
Acute Postoperative Pain (With NRS )
with coughing - 2 hour
|
6 NRS score
Interval 3.7 to 8.0
|
6 NRS score
Interval 5.0 to 7.0
|
|
Acute Postoperative Pain (With NRS )
with coughing - 6 hour
|
6 NRS score
Interval 4.0 to 7.0
|
5 NRS score
Interval 4.0 to 8.0
|
|
Acute Postoperative Pain (With NRS )
with coughing - 12 hour
|
5 NRS score
Interval 3.0 to 7.0
|
5 NRS score
Interval 3.0 to 7.0
|
|
Acute Postoperative Pain (With NRS )
with coughing - 24 hour
|
5 NRS score
Interval 4.0 to 6.0
|
6 NRS score
Interval 3.0 to 7.0
|
|
Acute Postoperative Pain (With NRS )
with coughing - 48 hour
|
4 NRS score
Interval 2.2 to 6.0
|
4 NRS score
Interval 3.0 to 8.0
|
|
Acute Postoperative Pain (With NRS )
with coughing - 72 hour
|
3 NRS score
Interval 1.0 to 4.0
|
4 NRS score
Interval 3.0 to 5.0
|
|
Acute Postoperative Pain (With NRS )
with movement - 24 hour
|
4 NRS score
Interval 2.7 to 5.2
|
5 NRS score
Interval 3.0 to 7.0
|
|
Acute Postoperative Pain (With NRS )
with movement - 48 hour
|
2.5 NRS score
Interval 1.2 to 5.0
|
4 NRS score
Interval 3.0 to 6.0
|
|
Acute Postoperative Pain (With NRS )
At rest - 48 hour
|
2 NRS score
Interval 2.0 to 4.0
|
2 NRS score
Interval 0.0 to 5.0
|
|
Acute Postoperative Pain (With NRS )
At rest - 20 minute
|
3.5 NRS score
Interval 1.0 to 6.3
|
3 NRS score
Interval 0.0 to 5.0
|
|
Acute Postoperative Pain (With NRS )
At rest - 2 hour
|
4 NRS score
Interval 2.0 to 6.0
|
4 NRS score
Interval 3.0 to 6.0
|
|
Acute Postoperative Pain (With NRS )
At rest - 6 hour
|
3.5 NRS score
Interval 1.7 to 5.0
|
4 NRS score
Interval 2.0 to 6.0
|
|
Acute Postoperative Pain (With NRS )
At rest - 12 hour
|
3 NRS score
Interval 1.0 to 5.0
|
4 NRS score
Interval 1.0 to 6.0
|
|
Acute Postoperative Pain (With NRS )
At rest - 24 hour
|
3 NRS score
Interval 1.0 to 4.0
|
4 NRS score
Interval 1.0 to 5.0
|
|
Acute Postoperative Pain (With NRS )
At rest - 72 hour
|
1 NRS score
Interval 0.0 to 3.0
|
2 NRS score
Interval 0.0 to 3.0
|
|
Acute Postoperative Pain (With NRS )
with movement - 20 minute
|
4 NRS score
Interval 2.0 to 7.2
|
4 NRS score
Interval 2.0 to 5.0
|
|
Acute Postoperative Pain (With NRS )
with movement - 2 hour
|
6 NRS score
Interval 3.0 to 8.0
|
6 NRS score
Interval 4.0 to 7.0
|
|
Acute Postoperative Pain (With NRS )
with movement - 6 hour
|
5.5 NRS score
Interval 3.0 to 7.0
|
5 NRS score
Interval 3.0 to 7.0
|
|
Acute Postoperative Pain (With NRS )
with movement - 12 hour
|
4 NRS score
Interval 2.0 to 6.0
|
5 NRS score
Interval 2.0 to 7.0
|
SECONDARY outcome
Timeframe: postoperative 3. month, 6. monthPopulation: In the PVB group, three patients were lost to follow-up (two due to patient non-compliance and one due to incomplete data collection). Therefore, 40 patients in the ESPB group and 37 patients in the PVB group were included in the final analysis.
Pain severity was assessed using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable). Chronic pain was assessed via telephone interview at 3 and 6 months using a structured questionnaire based on ICD-11 criteria. CPSP was defined as pain localized to the surgical field, persisting for at least 3 months, with NRS ≥1, and not explained by other causes. Pain severity was categorized as mild (NRS 1-3), moderate (NRS 4-6), or severe (NRS 7-10), with NRS ≥4 analyzed as moderate-to-severe pain.
Outcome measures
| Measure |
Group E
n=40 Participants
After the study was initiated, patients were allocated to groups according to their chronological order of surgery as follows:
E ARM (ESP Group):
Patients numbered 1, 3, 4, 6, 8, 10, 14, 15, 17, 18, 22, 23, 24, 27, 28, 29, 32, 33, 36, 38, 44, 45, 46, 47, 53, 54, 55, 56, 57, 58, 61, 64, 65, 68, 70, 72, 73, 76, 77 and 80 in the surgical sequence were assigned to the ESP group.
Erector spina plan block : Under USG guidance, local anaesthetic will be administered to the fascial plane between the erector spinae muscle and the transverse process.
Erector spina plan block (ESP): In both groups, the relevant methods will be applied at the level of the surgical incision before the surgical incision (pre-emptive) after the patient is asleep and before the patient wakes up at the end of surgery.
The dose of local anaesthetic to be administered is the same for both groups.
Drug content to be administered\*: total 25 cc volume (13.5 ml 0.5% bupivacaine + 5 ml 2% lidocaine + 1.5 ml morphine (morphine diluted with 0.9% NaCl to 1mg/ml) + 5 ml 0.9% NaCl) (These doses are the routine doses applied in such surgeries in our clinic)
\* Local anaesthetic drug doses in regional anaesthesia: source: Kirk, P. H. I. I. L. I. I. P. P., \& Berde, C. B. (2020). Local anaesthetics. Miller's Anaesthesia. 9th ed. Philadelphia: Elsevier Inc, 878-9.
|
Group P
n=37 Participants
After the study was initiated, patients were allocated to groups according to their chronological order of surgery as follows:
P ARM (Paravertebral Group):
Patients numbered 2, 5, 7, 9, 11, 12, 13, 16, 19, 20, 21, 25, 26, 30, 31, 34, 35, 37, 39, 40, 41, 42, 43, 48, 49, 50, 51, 52, 59, 60, 62, 63, 66, 67, 69, 71, 74, 75, 78 and 79 in the surgical sequence were assigned to the Paravertebral group.
Paravertebral block: USG-guided local anaesthetic administration to the side of the vertebral body close to where the spinal nerves exit from the intervertebral foramen.
Paravertebral block: In both groups, the relevant methods will be applied at the level of the surgical incision before the surgical incision (pre-emptive) after the patient is asleep and before the patient wakes up at the end of surgery.
The dose of local anaesthetic to be administered is the same for both groups.
Drug content to be administered\*: total 25 cc volume (13.5 ml 0.5% bupivacaine + 5 ml 2% lidocaine + 1.5 ml morphine (morphine diluted with 0.9% NaCl to 1mg/ml) + 5 ml 0.9% NaCl) (These doses are the routine doses applied in such surgeries in our clinic)
\* Local anaesthetic drug doses in regional anaesthesia: source: Kirk, P. H. I. I. L. I. I. P. P., \& Berde, C. B. (2020). Local anaesthetics. Miller's Anaesthesia. 9th ed. Philadelphia: Elsevier Inc, 878-9.
|
|---|---|---|
|
Chronic Postoperative Pain
CPSP ( NRS ≥1) : 3 month · 3 month
|
18 participants
|
18 participants
|
|
Chronic Postoperative Pain
CPSP ( NRS ≥4) : 3 month · 3 month
|
10 participants
|
9 participants
|
|
Chronic Postoperative Pain
Need for additional analgesics : 3 month · 3 month
|
10 participants
|
9 participants
|
|
Chronic Postoperative Pain
CPSP ( NRS ≥1) : 6 month · 3 month
|
11 participants
|
5 participants
|
|
Chronic Postoperative Pain
CPSP ( NRS ≥4) : 6 month · 3 month
|
1 participants
|
0 participants
|
|
Chronic Postoperative Pain
Need for additional analgesics : 6 month · 3 month
|
2 participants
|
2 participants
|
Adverse Events
Group E
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group P
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group E
n=40 participants at risk
After the study was initiated, patients were allocated to groups according to their chronological order of surgery as follows:
E ARM (ESP Group):
Patients numbered 1, 3, 4, 6, 8, 10, 14, 15, 17, 18, 22, 23, 24, 27, 28, 29, 32, 33, 36, 38, 44, 45, 46, 47, 53, 54, 55, 56, 57, 58, 61, 64, 65, 68, 70, 72, 73, 76, 77 and 80 in the surgical sequence were assigned to the ESP group.
Erector spina plan block : Under USG guidance, local anaesthetic will be administered to the fascial plane between the erector spinae muscle and the transverse process.
Erector spina plan block (ESP): In both groups, the relevant methods will be applied at the level of the surgical incision before the surgical incision (pre-emptive) after the patient is asleep and before the patient wakes up at the end of surgery.
The dose of local anaesthetic to be administered is the same for both groups.
Drug content to be administered\*: total 25 cc volume (13.5 ml 0.5% bupivacaine + 5 ml 2% lidocaine + 1.5 ml morphine (morphine diluted with 0.9% NaCl to 1mg/ml) + 5 ml 0.9% NaCl) (These doses are the routine doses applied in such surgeries in our clinic)
\* Local anaesthetic drug doses in regional anaesthesia: source: Kirk, P. H. I. I. L. I. I. P. P., \& Berde, C. B. (2020). Local anaesthetics. Miller's Anaesthesia. 9th ed. Philadelphia: Elsevier Inc, 878-9.
|
Group P
n=37 participants at risk
After the study was initiated, patients were allocated to groups according to their chronological order of surgery as follows:
P ARM (Paravertebral Group):
Patients numbered 2, 5, 7, 9, 11, 12, 13, 16, 19, 20, 21, 25, 26, 30, 31, 34, 35, 37, 39, 40, 41, 42, 43, 48, 49, 50, 51, 52, 59, 60, 62, 63, 66, 67, 69, 71, 74, 75, 78 and 79 in the surgical sequence were assigned to the Paravertebral group.
Paravertebral block: USG-guided local anaesthetic administration to the side of the vertebral body close to where the spinal nerves exit from the intervertebral foramen.
Paravertebral block: In both groups, the relevant methods will be applied at the level of the surgical incision before the surgical incision (pre-emptive) after the patient is asleep and before the patient wakes up at the end of surgery.
The dose of local anaesthetic to be administered is the same for both groups.
Drug content to be administered\*: total 25 cc volume (13.5 ml 0.5% bupivacaine + 5 ml 2% lidocaine + 1.5 ml morphine (morphine diluted with 0.9% NaCl to 1mg/ml) + 5 ml 0.9% NaCl) (These doses are the routine doses applied in such surgeries in our clinic)
\* Local anaesthetic drug doses in regional anaesthesia: source: Kirk, P. H. I. I. L. I. I. P. P., \& Berde, C. B. (2020). Local anaesthetics. Miller's Anaesthesia. 9th ed. Philadelphia: Elsevier Inc, 878-9.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
17.5%
7/40 • from the date of registration until the end of the chronic pain assessment (24 weeks)
Adverse events were actively monitored and recorded during both acute and chronic pain assessments. In the acute postoperative period, patients were observed and directly asked, 'Do you have any complaints?' during routine clinical evaluations. At the 3- and 6-month chronic pain follow-ups, adverse events were also queried using the same verbal question as part of the structured telephone interview.
|
16.2%
6/37 • from the date of registration until the end of the chronic pain assessment (24 weeks)
Adverse events were actively monitored and recorded during both acute and chronic pain assessments. In the acute postoperative period, patients were observed and directly asked, 'Do you have any complaints?' during routine clinical evaluations. At the 3- and 6-month chronic pain follow-ups, adverse events were also queried using the same verbal question as part of the structured telephone interview.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
4/40 • from the date of registration until the end of the chronic pain assessment (24 weeks)
Adverse events were actively monitored and recorded during both acute and chronic pain assessments. In the acute postoperative period, patients were observed and directly asked, 'Do you have any complaints?' during routine clinical evaluations. At the 3- and 6-month chronic pain follow-ups, adverse events were also queried using the same verbal question as part of the structured telephone interview.
|
5.4%
2/37 • from the date of registration until the end of the chronic pain assessment (24 weeks)
Adverse events were actively monitored and recorded during both acute and chronic pain assessments. In the acute postoperative period, patients were observed and directly asked, 'Do you have any complaints?' during routine clinical evaluations. At the 3- and 6-month chronic pain follow-ups, adverse events were also queried using the same verbal question as part of the structured telephone interview.
|
|
Gastrointestinal disorders
Itching
|
5.0%
2/40 • from the date of registration until the end of the chronic pain assessment (24 weeks)
Adverse events were actively monitored and recorded during both acute and chronic pain assessments. In the acute postoperative period, patients were observed and directly asked, 'Do you have any complaints?' during routine clinical evaluations. At the 3- and 6-month chronic pain follow-ups, adverse events were also queried using the same verbal question as part of the structured telephone interview.
|
0.00%
0/37 • from the date of registration until the end of the chronic pain assessment (24 weeks)
Adverse events were actively monitored and recorded during both acute and chronic pain assessments. In the acute postoperative period, patients were observed and directly asked, 'Do you have any complaints?' during routine clinical evaluations. At the 3- and 6-month chronic pain follow-ups, adverse events were also queried using the same verbal question as part of the structured telephone interview.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place