Trial Outcomes & Findings for Superior Hypogastric Blockade for Postoperative Pain (NCT NCT03428152)
NCT ID: NCT03428152
Last Updated: 2024-03-13
Results Overview
Patients' pain scores will be scored with a 10 cm Visual Analogue Scale (VAS). Each will be scored between 0-10 (0: no pain; 10: worst pain ever) (PACU: Post-anesthesia care unit) VAS-PACU: VAS scores at PACU VAS 1: VAS scores at postoperative 1st hour (ward) VAS 6: VAS scores at postoperative 6th hour (ward) VAS 12: VAS scores at postoperative 12th hour (ward) VAS 24: VAS scores at postoperative 24th hour (ward) VAS 48: VAS scores at postoperative 48th hour (ward)
COMPLETED
78 participants
postoperative 48 hour follow-up (PACU and ward)
2024-03-13
Participant Flow
Participant milestones
| Measure |
Hypo
The participants with a superior hypogastric block
superior hypogastric block: superior hypogastric blockade during surgery
|
NoHypo
The participants without a superior hypogastric block; the patients with an epidural catheter, who receive a different block technique (ie: TAP block), or who are unsuitable for SHP block (ie: if retro-peritoneum is opened intraoperatively by the surgeon)
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
41
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
7
|
11
|
Reasons for withdrawal
| Measure |
Hypo
The participants with a superior hypogastric block
superior hypogastric block: superior hypogastric blockade during surgery
|
NoHypo
The participants without a superior hypogastric block; the patients with an epidural catheter, who receive a different block technique (ie: TAP block), or who are unsuitable for SHP block (ie: if retro-peritoneum is opened intraoperatively by the surgeon)
|
|---|---|---|
|
Overall Study
Physician Decision
|
4
|
2
|
|
Overall Study
Protocol Violation
|
3
|
5
|
|
Overall Study
Lack of Efficacy
|
0
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Hypo
n=37 Participants
The participants with a superior hypogastric block
superior hypogastric block: superior hypogastric blockade during surgery
|
NoHypo
n=41 Participants
The participants without a superior hypogastric block; the patients with an epidural catheter, who receive a different block technique (ie: TAP block), or who are unsuitable for SHP block (ie: if retro-peritoneum is opened intraoperatively by the surgeon)
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.36 years
STANDARD_DEVIATION 6.51 • n=37 Participants
|
51.63 years
STANDARD_DEVIATION 7.49 • n=41 Participants
|
52 years
STANDARD_DEVIATION 6.96 • n=78 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=37 Participants
|
41 Participants
n=41 Participants
|
78 Participants
n=78 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=37 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=78 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Turkey
|
37 Participants
n=37 Participants
|
41 Participants
n=41 Participants
|
78 Participants
n=78 Participants
|
PRIMARY outcome
Timeframe: postoperative 48 hour follow-up (PACU and ward)Population: 37 patients with a superior hypogastric block (7 was excluded); 41 patients without a superior hypogastric block (11 was excluded).
Patients' pain scores will be scored with a 10 cm Visual Analogue Scale (VAS). Each will be scored between 0-10 (0: no pain; 10: worst pain ever) (PACU: Post-anesthesia care unit) VAS-PACU: VAS scores at PACU VAS 1: VAS scores at postoperative 1st hour (ward) VAS 6: VAS scores at postoperative 6th hour (ward) VAS 12: VAS scores at postoperative 12th hour (ward) VAS 24: VAS scores at postoperative 24th hour (ward) VAS 48: VAS scores at postoperative 48th hour (ward)
Outcome measures
| Measure |
Hypo
n=37 Participants
The participants with a superior hypogastric block
superior hypogastric block: superior hypogastric blockade during surgery
|
NoHypo
n=41 Participants
The participants without a superior hypogastric block; the patients with an epidural catheter, who receive a different block technique (ie: TAP block), or who are unsuitable for SHP block (ie: if retro-peritoneum is opened intraoperatively by the surgeon)
|
|---|---|---|
|
Postoperative Pain Scores
VAS 1
|
3.7 units on a scale
Standard Deviation 3.36
|
6.66 units on a scale
Standard Deviation 2.10
|
|
Postoperative Pain Scores
VAS PACU
|
4.76 units on a scale
Standard Deviation 1.55
|
7.38 units on a scale
Standard Deviation 1.63
|
|
Postoperative Pain Scores
VAS 6
|
1.9 units on a scale
Standard Deviation 1.32
|
4.23 units on a scale
Standard Deviation 2.03
|
|
Postoperative Pain Scores
VAS 12
|
0.83 units on a scale
Standard Deviation 0.74
|
3.16 units on a scale
Standard Deviation 2.13
|
|
Postoperative Pain Scores
VAS 24
|
0.53 units on a scale
Standard Deviation 0.68
|
2.1 units on a scale
Standard Deviation 2.17
|
|
Postoperative Pain Scores
VAS 48
|
0.2 units on a scale
Standard Deviation 0.4
|
1.2 units on a scale
Standard Deviation 1.39
|
PRIMARY outcome
Timeframe: postoperative 48 hour follow-up (PACU and ward)Total number of non-steroid anti-inflammatory drug (NSAID) and opioid vials that are applied to patients in post-anesthesia care unit (PACU) and at ward will be recorded. Target VAS score for NSAID is \>4; if there is no response to NSAID and pain is worsening opioid drugs will be applied (this is our routine clinical practice) NSAID: Diclofenac sodium 75mg per vial; opioid: Tramadol 100mg per vial.
Outcome measures
| Measure |
Hypo
n=37 Participants
The participants with a superior hypogastric block
superior hypogastric block: superior hypogastric blockade during surgery
|
NoHypo
n=41 Participants
The participants without a superior hypogastric block; the patients with an epidural catheter, who receive a different block technique (ie: TAP block), or who are unsuitable for SHP block (ie: if retro-peritoneum is opened intraoperatively by the surgeon)
|
|---|---|---|
|
Postoperative Analgesic Consumption
NSAID PACU
|
0.8 vials
Standard Deviation 0.4
|
0.96 vials
Standard Deviation 0.18
|
|
Postoperative Analgesic Consumption
Opioid PACU
|
0.1 vials
Standard Deviation 0.3
|
0.36 vials
Standard Deviation 0.49
|
|
Postoperative Analgesic Consumption
NSAID ward
|
2.83 vials
Standard Deviation 1.23
|
5.77 vials
Standard Deviation 1.24
|
|
Postoperative Analgesic Consumption
Opioid ward
|
0 vials
Standard Deviation 0
|
0.63 vials
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: 48 hours (time to the first analgesic demand will be recorded)Time to first analgesic demand at gynecology ward (after transfer from PACU to gynecology ward)
Outcome measures
| Measure |
Hypo
n=37 Participants
The participants with a superior hypogastric block
superior hypogastric block: superior hypogastric blockade during surgery
|
NoHypo
n=41 Participants
The participants without a superior hypogastric block; the patients with an epidural catheter, who receive a different block technique (ie: TAP block), or who are unsuitable for SHP block (ie: if retro-peritoneum is opened intraoperatively by the surgeon)
|
|---|---|---|
|
Rescue Analgesic Time
|
627 minutes
Standard Deviation 352.89
|
203.83 minutes
Standard Deviation 173.13
|
SECONDARY outcome
Timeframe: from the induction of anesthesia and the end of the surgerythe time from the the first incision to the skin to skin closure.
Outcome measures
| Measure |
Hypo
n=37 Participants
The participants with a superior hypogastric block
superior hypogastric block: superior hypogastric blockade during surgery
|
NoHypo
n=41 Participants
The participants without a superior hypogastric block; the patients with an epidural catheter, who receive a different block technique (ie: TAP block), or who are unsuitable for SHP block (ie: if retro-peritoneum is opened intraoperatively by the surgeon)
|
|---|---|---|
|
Duration of Operation
|
115.83 minutes
Standard Deviation 34.19
|
114.16 minutes
Standard Deviation 34.59
|
SECONDARY outcome
Timeframe: assessed up to 1 weeklength of hospital stay time will be recorded
Outcome measures
| Measure |
Hypo
n=37 Participants
The participants with a superior hypogastric block
superior hypogastric block: superior hypogastric blockade during surgery
|
NoHypo
n=41 Participants
The participants without a superior hypogastric block; the patients with an epidural catheter, who receive a different block technique (ie: TAP block), or who are unsuitable for SHP block (ie: if retro-peritoneum is opened intraoperatively by the surgeon)
|
|---|---|---|
|
Length of Hospital Stay
|
2.66 days
Standard Deviation 0.6
|
2.96 days
Standard Deviation 1.32
|
SECONDARY outcome
Timeframe: From the SHP block time (intraoperative) until dischargeintra/postoperative complications will be noted. (post-operative nausea and vomiting (PONV) or others: ie: intra-vascular local anesthetic injection, vascular puncture, hemodynamical changes after injection,.. )
Outcome measures
| Measure |
Hypo
n=30 Participants
The participants with a superior hypogastric block
superior hypogastric block: superior hypogastric blockade during surgery
|
NoHypo
n=30 Participants
The participants without a superior hypogastric block; the patients with an epidural catheter, who receive a different block technique (ie: TAP block), or who are unsuitable for SHP block (ie: if retro-peritoneum is opened intraoperatively by the surgeon)
|
|---|---|---|
|
Number of Participants With Complications Due to SHP Block
PONV
|
7 Participants
|
8 Participants
|
|
Number of Participants With Complications Due to SHP Block
others
|
0 Participants
|
0 Participants
|
Adverse Events
Hypo
NoHypo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place