Trial Outcomes & Findings for Thoraco Lumbar Vertebral Length and Bupivacaine Dosage in C-Section (NCT NCT06869434)
NCT ID: NCT06869434
Last Updated: 2026-04-24
Results Overview
Maternal hypotension was defined as a decrease in systolic blood pressure of more than 20% from baseline or a systolic blood pressure \<90 mmHg. The incidence of hypotension was recorded intraoperatively for each participant.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
446 participants
Primary outcome timeframe
From initiation of spinal anesthesia to completion of surgery, during the intraoperative period (mean duration approximately 60-90 minutes)
Results posted on
2026-04-24
Participant Flow
1\. American Society of Anesthesiologists (ASA) Class II 2. Regular antenatal visits 3. Singleton pregnancy at ≥37 weeks gestation 4. Pregnant women aged 18-45
1\. Eclampsia, those with preeclampsia 2. Those who underwent an emergency cesarean section 3. Those with bleeding diathesis and those on anticoagulant therapy 4. Patients with a history of carotid artery stenosis, 5. Cardiovascular disease, 6. Hypertension, 7. Chronic obstructive pulmonary disease, 8. Heart rhythm other than sinus rhythm, 9. Patients with a history of cerebrovascular disease. 10. Alcoholism or psychiatric illness 11. Placenta previa, accreta, and percreta.
Participant milestones
| Measure |
Group VBL (Vertebral Body Length) Received 0.2 mg x VBL cm of %0.5 Hyperbaric Bupivacaine,
Patients in Group VBL (Vertebral body length) received 0.2 mg x VBL cm of 0.5% hyperbaric bupivacaine
Group VBL (Thoracolumbal vertebral body length) received 0.2 mg x VBL cm of %0.5 hyperbaric bupivacaine: intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight. A dosage was derived using Harten's dose chart formulated for Caucasian parturients
|
Group FD (Fixed Dose) Received 0.065 mg/cm 0.5% Hyperbaric Bupivacaine
Group FD (Fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated according to the patient's height 0.065 mg/cm
Group FD (Fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated according to the patient's height 0.065 mg/cm: Group FD (Fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated according to the patient's height 0.065 mg/cm
|
Group AD (Adjusted Dosage) Received Heavy Bupivacaine (0.5%) Patient's Height and Weight
Group AD (adjusted dosage) received intrathecal heavy bupivacaine (0.5%) based on the patient's height and weight.
Group AD (Adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight : Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight.
|
|---|---|---|---|
|
Overall Study
STARTED
|
149
|
149
|
148
|
|
Overall Study
COMPLETED
|
85
|
85
|
85
|
|
Overall Study
NOT COMPLETED
|
64
|
64
|
63
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A total of 255 patients include in the study, 85 patients analysed in each group. (excluding patients with protocol violations or conversion to general anesthesia)169 patients not meeting inclusion criteria, 13 patients declined to participate (total 182) and 88 patients allocated. Nine patients (three from each group) were excluded from the final analysis due to protocol violations or conversion to general anaesthesia.
Baseline characteristics by cohort
| Measure |
Group VBL (Vertebral Body Length) Received 0.2 mg x VBL cm of %0.5 Hyperbaric Bupivacaine,
n=85 Participants
Patients in Group VBL (Vertebral body length) received 0.2 mg x VBL cm of 0.5% hyperbaric bupivacaine
Group VBL (Thoracolumbal vertebral body length) received 0.2 mg x VBL cm of %0.5 hyperbaric bupivacaine: intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight. A dosage was derived using Harten's dose chart formulated for Caucasian parturients
|
Group FD (Fixed Dose) Received a Volume of 0.5% Hyperbaric Bupivacaine Based on a Dose Calculated ac
n=85 Participants
Group FD (fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated according to the patient's height 0.065 mg/cm
Group FD (fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated according to the patient's height 0.065 mg/cm: Group FD (fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated according to the patient's height 0.065 mg/cm
|
Group AD (Adjusted Dosage) Got Intrathecal Heavy Bupivacaine (0.5%) Tailored to the Patient's Height
n=85 Participants
Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight
Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight.: Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight.
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants • A total of 255 patients include in the study, 85 patients analysed in each group. (excluding patients with protocol violations or conversion to general anesthesia)169 patients not meeting inclusion criteria, 13 patients declined to participate (total 182) and 88 patients allocated. Nine patients (three from each group) were excluded from the final analysis due to protocol violations or conversion to general anaesthesia.
|
0 Participants
n=1 Participants • A total of 255 patients include in the study, 85 patients analysed in each group. (excluding patients with protocol violations or conversion to general anesthesia)169 patients not meeting inclusion criteria, 13 patients declined to participate (total 182) and 88 patients allocated. Nine patients (three from each group) were excluded from the final analysis due to protocol violations or conversion to general anaesthesia.
|
0 Participants
n=3 Participants • A total of 255 patients include in the study, 85 patients analysed in each group. (excluding patients with protocol violations or conversion to general anesthesia)169 patients not meeting inclusion criteria, 13 patients declined to participate (total 182) and 88 patients allocated. Nine patients (three from each group) were excluded from the final analysis due to protocol violations or conversion to general anaesthesia.
|
0 Participants
n=24 Participants • A total of 255 patients include in the study, 85 patients analysed in each group. (excluding patients with protocol violations or conversion to general anesthesia)169 patients not meeting inclusion criteria, 13 patients declined to participate (total 182) and 88 patients allocated. Nine patients (three from each group) were excluded from the final analysis due to protocol violations or conversion to general anaesthesia.
|
|
Age, Categorical
Between 18 and 65 years
|
85 Participants
n=2 Participants • A total of 255 patients include in the study, 85 patients analysed in each group. (excluding patients with protocol violations or conversion to general anesthesia)169 patients not meeting inclusion criteria, 13 patients declined to participate (total 182) and 88 patients allocated. Nine patients (three from each group) were excluded from the final analysis due to protocol violations or conversion to general anaesthesia.
|
85 Participants
n=1 Participants • A total of 255 patients include in the study, 85 patients analysed in each group. (excluding patients with protocol violations or conversion to general anesthesia)169 patients not meeting inclusion criteria, 13 patients declined to participate (total 182) and 88 patients allocated. Nine patients (three from each group) were excluded from the final analysis due to protocol violations or conversion to general anaesthesia.
|
85 Participants
n=3 Participants • A total of 255 patients include in the study, 85 patients analysed in each group. (excluding patients with protocol violations or conversion to general anesthesia)169 patients not meeting inclusion criteria, 13 patients declined to participate (total 182) and 88 patients allocated. Nine patients (three from each group) were excluded from the final analysis due to protocol violations or conversion to general anaesthesia.
|
255 Participants
n=24 Participants • A total of 255 patients include in the study, 85 patients analysed in each group. (excluding patients with protocol violations or conversion to general anesthesia)169 patients not meeting inclusion criteria, 13 patients declined to participate (total 182) and 88 patients allocated. Nine patients (three from each group) were excluded from the final analysis due to protocol violations or conversion to general anaesthesia.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=2 Participants • A total of 255 patients include in the study, 85 patients analysed in each group. (excluding patients with protocol violations or conversion to general anesthesia)169 patients not meeting inclusion criteria, 13 patients declined to participate (total 182) and 88 patients allocated. Nine patients (three from each group) were excluded from the final analysis due to protocol violations or conversion to general anaesthesia.
|
0 Participants
n=1 Participants • A total of 255 patients include in the study, 85 patients analysed in each group. (excluding patients with protocol violations or conversion to general anesthesia)169 patients not meeting inclusion criteria, 13 patients declined to participate (total 182) and 88 patients allocated. Nine patients (three from each group) were excluded from the final analysis due to protocol violations or conversion to general anaesthesia.
|
0 Participants
n=3 Participants • A total of 255 patients include in the study, 85 patients analysed in each group. (excluding patients with protocol violations or conversion to general anesthesia)169 patients not meeting inclusion criteria, 13 patients declined to participate (total 182) and 88 patients allocated. Nine patients (three from each group) were excluded from the final analysis due to protocol violations or conversion to general anaesthesia.
|
0 Participants
n=24 Participants • A total of 255 patients include in the study, 85 patients analysed in each group. (excluding patients with protocol violations or conversion to general anesthesia)169 patients not meeting inclusion criteria, 13 patients declined to participate (total 182) and 88 patients allocated. Nine patients (three from each group) were excluded from the final analysis due to protocol violations or conversion to general anaesthesia.
|
|
Age, Continuous
|
29.7 yr
STANDARD_DEVIATION 6.20 • n=2 Participants • Analysis was performed on a per-protocol basis, excluding patients (64 in Group 1, 64 in Group 2, and 63 in Group 3) who violated the protocol or converted to general anesthesia.
|
30 yr
STANDARD_DEVIATION 5.85 • n=1 Participants • Analysis was performed on a per-protocol basis, excluding patients (64 in Group 1, 64 in Group 2, and 63 in Group 3) who violated the protocol or converted to general anesthesia.
|
29.9 yr
STANDARD_DEVIATION 6.49 • n=3 Participants • Analysis was performed on a per-protocol basis, excluding patients (64 in Group 1, 64 in Group 2, and 63 in Group 3) who violated the protocol or converted to general anesthesia.
|
29.8 yr
STANDARD_DEVIATION 6.15 • n=24 Participants • Analysis was performed on a per-protocol basis, excluding patients (64 in Group 1, 64 in Group 2, and 63 in Group 3) who violated the protocol or converted to general anesthesia.
|
|
Sex: Female, Male
Female
|
85 Participants
n=2 Participants • A total of 255 patients include in the study, 85 patients analysed in each group. 169 patients not meeting inclusion criteria, 13 patients declined to participate (total 182) and 88 patients allocated. Nine patients (three from each group) were excluded from the final analysis due to protocol violations or conversion to general anaesthesia.
|
85 Participants
n=1 Participants • A total of 255 patients include in the study, 85 patients analysed in each group. 169 patients not meeting inclusion criteria, 13 patients declined to participate (total 182) and 88 patients allocated. Nine patients (three from each group) were excluded from the final analysis due to protocol violations or conversion to general anaesthesia.
|
85 Participants
n=3 Participants • A total of 255 patients include in the study, 85 patients analysed in each group. 169 patients not meeting inclusion criteria, 13 patients declined to participate (total 182) and 88 patients allocated. Nine patients (three from each group) were excluded from the final analysis due to protocol violations or conversion to general anaesthesia.
|
255 Participants
n=24 Participants • A total of 255 patients include in the study, 85 patients analysed in each group. 169 patients not meeting inclusion criteria, 13 patients declined to participate (total 182) and 88 patients allocated. Nine patients (three from each group) were excluded from the final analysis due to protocol violations or conversion to general anaesthesia.
|
|
Sex: Female, Male
Male
|
0 Participants
n=2 Participants • A total of 255 patients include in the study, 85 patients analysed in each group. 169 patients not meeting inclusion criteria, 13 patients declined to participate (total 182) and 88 patients allocated. Nine patients (three from each group) were excluded from the final analysis due to protocol violations or conversion to general anaesthesia.
|
0 Participants
n=1 Participants • A total of 255 patients include in the study, 85 patients analysed in each group. 169 patients not meeting inclusion criteria, 13 patients declined to participate (total 182) and 88 patients allocated. Nine patients (three from each group) were excluded from the final analysis due to protocol violations or conversion to general anaesthesia.
|
0 Participants
n=3 Participants • A total of 255 patients include in the study, 85 patients analysed in each group. 169 patients not meeting inclusion criteria, 13 patients declined to participate (total 182) and 88 patients allocated. Nine patients (three from each group) were excluded from the final analysis due to protocol violations or conversion to general anaesthesia.
|
0 Participants
n=24 Participants • A total of 255 patients include in the study, 85 patients analysed in each group. 169 patients not meeting inclusion criteria, 13 patients declined to participate (total 182) and 88 patients allocated. Nine patients (three from each group) were excluded from the final analysis due to protocol violations or conversion to general anaesthesia.
|
|
Race/Ethnicity, Customized
|
85 Participants
n=2 Participants • Analysis was performed on a per-protocol basis, excluding patients with protocol violations or conversion to general anesthesia.
|
85 Participants
n=1 Participants • Analysis was performed on a per-protocol basis, excluding patients with protocol violations or conversion to general anesthesia.
|
85 Participants
n=3 Participants • Analysis was performed on a per-protocol basis, excluding patients with protocol violations or conversion to general anesthesia.
|
255 Participants
n=24 Participants • Analysis was performed on a per-protocol basis, excluding patients with protocol violations or conversion to general anesthesia.
|
|
Region of Enrollment
Turkey
|
85 participants
n=2 Participants • Analysis was performed on a per-protocol basis, excluding patients with protocol violations or conversion to general anesthesia.
|
85 participants
n=1 Participants • Analysis was performed on a per-protocol basis, excluding patients with protocol violations or conversion to general anesthesia.
|
85 participants
n=3 Participants • Analysis was performed on a per-protocol basis, excluding patients with protocol violations or conversion to general anesthesia.
|
255 participants
n=24 Participants • Analysis was performed on a per-protocol basis, excluding patients with protocol violations or conversion to general anesthesia.
|
PRIMARY outcome
Timeframe: From initiation of spinal anesthesia to completion of surgery, during the intraoperative period (mean duration approximately 60-90 minutes)Population: Cesarean delivery patients
Maternal hypotension was defined as a decrease in systolic blood pressure of more than 20% from baseline or a systolic blood pressure \<90 mmHg. The incidence of hypotension was recorded intraoperatively for each participant.
Outcome measures
| Measure |
Group VBL (Vertebral Body Length) Received 0.2 mg x VBL cm of %0.5 Hyperbaric Bupivacaine,
n=85 Participants
Patients in Group VBL (Vertebral body length) received 0.2 mg x VBL cm of 0.5% hyperbaric bupivacaine
Group VBL (Thoracolumbal vertebral body length) received 0.2 mg x VBL cm of %0.5 hyperbaric bupivacaine: intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight. A dosage was derived using Harten's dose chart formulated for Caucasian parturients
|
Group FD (Fixed Dose) Received a Volume of 0.5% Hyperbaric Bupivacaine Based on a Dose Calculated ac
n=85 Participants
Group FD (fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated according to the patient's height 0.065 mg/cm
Group FD (fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated according to the patient's height 0.065 mg/cm: Group FD (fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated according to the patient's height 0.065 mg/cm
|
Group AD (Adjusted Dosage) Got Intrathecal Heavy Bupivacaine (0.5%) Tailored to the Patient's Height
n=85 Participants
Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight
Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight.: Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight.
|
|---|---|---|---|
|
Hypotension Rate Among the Groups
|
9 Participants
|
26 Participants
|
37 Participants
|
Adverse Events
Group VBL (Vertebral Body Length) Received 0.2 mg x VBL cm of %0.5 Hyperbaric Bupivacaine,
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
Group FD (Fixed Dose) Received a Volume of 0.5% Hyperbaric Bupivacaine Based on a Dose Calculated ac
Serious events: 26 serious events
Other events: 0 other events
Deaths: 0 deaths
Group AD (Adjusted Dosage) Got Intrathecal Heavy Bupivacaine (0.5%) Tailored to the Patient's Height
Serious events: 37 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group VBL (Vertebral Body Length) Received 0.2 mg x VBL cm of %0.5 Hyperbaric Bupivacaine,
n=85 participants at risk
Patients in Group VBL (Vertebral body length) received 0.2 mg x VBL cm of 0.5% hyperbaric bupivacaine
Group VBL (Thoracolumbal vertebral body length) received 0.2 mg x VBL cm of %0.5 hyperbaric bupivacaine: intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight. A dosage was derived using Harten's dose chart formulated for Caucasian parturients
|
Group FD (Fixed Dose) Received a Volume of 0.5% Hyperbaric Bupivacaine Based on a Dose Calculated ac
n=85 participants at risk
Group FD (fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated according to the patient's height 0.065 mg/cm
Group FD (fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated according to the patient's height 0.065 mg/cm: Group FD (fixed dose) received a volume of 0.5% hyperbaric bupivacaine based on a dose calculated according to the patient's height 0.065 mg/cm
|
Group AD (Adjusted Dosage) Got Intrathecal Heavy Bupivacaine (0.5%) Tailored to the Patient's Height
n=85 participants at risk
Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight
Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight.: Group AD (adjusted dosage) got intrathecal heavy bupivacaine (0.5%) tailored to the patient's height and weight.
|
|---|---|---|---|
|
Cardiac disorders
hypotension
|
10.6%
9/85 • Number of events 85 • 6 months
|
30.6%
26/85 • Number of events 85 • 6 months
|
43.5%
37/85 • Number of events 85 • 6 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place