Trial Outcomes & Findings for RCT Superior Hypogastric Block During LH (NCT NCT03283436)
NCT ID: NCT03283436
Last Updated: 2020-10-27
Results Overview
The primary outcome will be immediate postoperative patient pain scores using the Visual Analog Scale (VAS) in the recovery unit. Postoperative pain scores will be collected every one hour, on a scale from 1 to 10. Higher score indicates greater pain intensity. The score reported here is the mean VAS score in the first 2 hours.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
100 participants
Primary outcome timeframe
Admission to recovery unit and every hour after for 2 hours
Results posted on
2020-10-27
Participant Flow
Participant milestones
| Measure |
Superior Hypogastric Plexus Block
Prior to the laparoscopic hysterectomy and any additional procedures, the SHPB will be performed on patients in the treatment arm. The block will contain 10 mL of 0.25% bupivacaine hydrochloride (Bupivacaine; 2.5 mg/mL = 25 mg). The anesthetic works by blocking nerve conduction and the steroid by reducing inflammation. The injection will be performed by tenting the presacral peritoneum, aspirating with a laparoscopic needle-tip syringe to ensure extravascular placement, and injecting the block.
Bupivacaine Hydrochloride 0.25% Injection Solution: 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)
|
No Block
Patients in the control arm will undergo the hysterectomy with no intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
44
|
50
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RCT Superior Hypogastric Block During LH
Baseline characteristics by cohort
| Measure |
Superior Hypogastric Plexus Block
n=50 Participants
Prior to the laparoscopic hysterectomy and any additional procedures, the SHPB will be performed on patients in the treatment arm. The block will contain 10 mL of 0.25% bupivacaine hydrochloride (Bupivacaine; 2.5 mg/mL = 25 mg). The anesthetic works by blocking nerve conduction and the steroid by reducing inflammation. The injection will be performed by tenting the presacral peritoneum, aspirating with a laparoscopic needle-tip syringe to ensure extravascular placement, and injecting the block.
Bupivacaine Hydrochloride 0.25% Injection Solution: 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)
|
No Block
n=50 Participants
Patients in the control arm will undergo the hysterectomy with no intervention.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 years
n=99 Participants
|
45 years
n=107 Participants
|
45 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White/Caucasian
|
35 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black/African American
|
8 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
50 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Body Mass Index (BMI)
|
28.7 kg/m^2
n=99 Participants
|
30.5 kg/m^2
n=107 Participants
|
29.5 kg/m^2
n=206 Participants
|
|
Gravidity
|
2 Pregnancies
n=99 Participants
|
2 Pregnancies
n=107 Participants
|
2 Pregnancies
n=206 Participants
|
|
Parity
|
2 Pregnancies
n=99 Participants
|
2 Pregnancies
n=107 Participants
|
2 Pregnancies
n=206 Participants
|
|
Indication for Surgery
Fibroids
|
25 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Indication for Surgery
Abnormal Uterine Bleeding
|
10 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Indication for Surgery
Pelvic pain
|
12 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Indication for Surgery
Other
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Admission to recovery unit and every hour after for 2 hoursThe primary outcome will be immediate postoperative patient pain scores using the Visual Analog Scale (VAS) in the recovery unit. Postoperative pain scores will be collected every one hour, on a scale from 1 to 10. Higher score indicates greater pain intensity. The score reported here is the mean VAS score in the first 2 hours.
Outcome measures
| Measure |
Superior Hypogastric Plexus Block
n=50 Participants
Prior to the laparoscopic hysterectomy and any additional procedures, the SHPB will be performed on patients in the treatment arm. The block will contain 10 mL of 0.25% bupivacaine hydrochloride (Bupivacaine; 2.5 mg/mL = 25 mg). The anesthetic works by blocking nerve conduction and the steroid by reducing inflammation. The injection will be performed by tenting the presacral peritoneum, aspirating with a laparoscopic needle-tip syringe to ensure extravascular placement, and injecting the block.
Bupivacaine Hydrochloride 0.25% Injection Solution: 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)
|
No Block
n=50 Participants
Patients in the control arm will undergo the hysterectomy with no intervention.
|
|---|---|---|
|
Postoperative Pain Scores
|
3.9 score on a scale
Interval 1.6 to 6.3
|
4.7 score on a scale
Interval 3.2 to 6.2
|
SECONDARY outcome
Timeframe: Admission to recovery unit to 1 week post op, assessed up to 1 week after surgeryPatients will be asked to complete a daily diary for one week that records their daily postoperative opioid consumption.
Outcome measures
| Measure |
Superior Hypogastric Plexus Block
n=50 Participants
Prior to the laparoscopic hysterectomy and any additional procedures, the SHPB will be performed on patients in the treatment arm. The block will contain 10 mL of 0.25% bupivacaine hydrochloride (Bupivacaine; 2.5 mg/mL = 25 mg). The anesthetic works by blocking nerve conduction and the steroid by reducing inflammation. The injection will be performed by tenting the presacral peritoneum, aspirating with a laparoscopic needle-tip syringe to ensure extravascular placement, and injecting the block.
Bupivacaine Hydrochloride 0.25% Injection Solution: 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)
|
No Block
n=50 Participants
Patients in the control arm will undergo the hysterectomy with no intervention.
|
|---|---|---|
|
Postoperative Opioid Use
postoperative day 0
|
5 milligrams morphine equivalents
Interval -1.9 to 11.9
|
10.2 milligrams morphine equivalents
Interval 4.0 to 16.5
|
|
Postoperative Opioid Use
postoperative day 1
|
2.5 milligrams morphine equivalents
Interval 0.0 to 5.0
|
5 milligrams morphine equivalents
Interval 0.0 to 10.0
|
|
Postoperative Opioid Use
postoperative day 2
|
0 milligrams morphine equivalents
Interval -2.5 to 2.5
|
2.5 milligrams morphine equivalents
Interval 0.0 to 5.0
|
|
Postoperative Opioid Use
postoperative day 3
|
0 milligrams morphine equivalents
Interval -1.3 to 1.3
|
3.5 milligrams morphine equivalents
Interval 1.0 to 6.0
|
|
Postoperative Opioid Use
postoperative day 4
|
0 milligrams morphine equivalents
Interval -1.3 to 1.3
|
0 milligrams morphine equivalents
Interval -1.3 to 1.3
|
|
Postoperative Opioid Use
postoperative day 5
|
0 milligrams morphine equivalents
Interval 0.0 to 0.0
|
0 milligrams morphine equivalents
Interval 0.0 to 0.0
|
|
Postoperative Opioid Use
postoperative day 6
|
0 milligrams morphine equivalents
Interval 0.0 to 0.0
|
0 milligrams morphine equivalents
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Discharge to 1 week after surgery, assessed up to 1 week after surgeryPatients will be asked to complete a daily diary for one week following the procedure, which details their pain level using VAS pain scores from the Brief Pain Inventory (BPI). Pain is reported on a scale of 1 to 10, and a higher score indicates greater pain intensity.
Outcome measures
| Measure |
Superior Hypogastric Plexus Block
n=50 Participants
Prior to the laparoscopic hysterectomy and any additional procedures, the SHPB will be performed on patients in the treatment arm. The block will contain 10 mL of 0.25% bupivacaine hydrochloride (Bupivacaine; 2.5 mg/mL = 25 mg). The anesthetic works by blocking nerve conduction and the steroid by reducing inflammation. The injection will be performed by tenting the presacral peritoneum, aspirating with a laparoscopic needle-tip syringe to ensure extravascular placement, and injecting the block.
Bupivacaine Hydrochloride 0.25% Injection Solution: 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)
|
No Block
n=50 Participants
Patients in the control arm will undergo the hysterectomy with no intervention.
|
|---|---|---|
|
Postoperative Pain Scores
postoperative day 0
|
5 score on a scale
Interval 2.3 to 7.8
|
6 score on a scale
Interval 4.6 to 7.4
|
|
Postoperative Pain Scores
postoperative day 1
|
6.3 score on a scale
Interval 4.5 to 8.1
|
5.6 score on a scale
Interval 4.2 to 7.0
|
|
Postoperative Pain Scores
postoperative day 2
|
5.5 score on a scale
Interval 3.6 to 7.5
|
5 score on a scale
Interval 3.9 to 6.2
|
|
Postoperative Pain Scores
postoperative day 3
|
4.1 score on a scale
Interval 2.4 to 5.8
|
4 score on a scale
Interval 2.6 to 5.4
|
|
Postoperative Pain Scores
postoperative day 4
|
4 score on a scale
Interval 2.3 to 5.7
|
4 score on a scale
Interval 2.5 to 5.5
|
|
Postoperative Pain Scores
postoperative day 5
|
3 score on a scale
Interval 1.5 to 4.6
|
3.5 score on a scale
Interval 2.3 to 4.8
|
|
Postoperative Pain Scores
postoperative day 6
|
2.8 score on a scale
Interval 1.3 to 4.4
|
2.8 score on a scale
Interval 1.6 to 4.1
|
Adverse Events
Superior Hypogastric Plexus Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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