Trial Outcomes & Findings for Reducing Post-Op Pain After Sacrospinous Ligament Colpopexy (NCT NCT02037061)
NCT ID: NCT02037061
Last Updated: 2019-08-14
Results Overview
Pain measured using a pain numeric rating scale from 0 to 10 (0=no pain, 10= worst pain imaginable)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
6-weeks
Results posted on
2019-08-14
Participant Flow
Participant milestones
| Measure |
Normal Saline
Intraoperatively the patient will receive 10ml of normal saline injected into the sacrospinous ligament.
Normal Saline
|
Bupivacaine
Intraoperatively the patient will receive 10 ml of bupivacaine injected into the sacrospinous ligament.
Bupivacaine: Intraoperatively the patient will receive 10ml of bupivacaine injected into the sacrospinous ligament.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
24
|
|
Overall Study
COMPLETED
|
22
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reducing Post-Op Pain After Sacrospinous Ligament Colpopexy
Baseline characteristics by cohort
| Measure |
Normal Saline
n=22 Participants
Intraoperatively the patient will receive 10ml of normal saline injected into the sacrospinous ligament.
Normal Saline
|
Bupivacaine
n=24 Participants
Intraoperatively the patient will receive 10 ml of bupivacaine injected into the sacrospinous ligament.
Bupivacaine: Intraoperatively the patient will receive 10ml of bupivacaine injected into the sacrospinous ligament.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age, Continuous
|
69 years
STANDARD_DEVIATION 7 • n=5 Participants
|
63 years
STANDARD_DEVIATION 9 • n=7 Participants
|
66 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6-weeksPain measured using a pain numeric rating scale from 0 to 10 (0=no pain, 10= worst pain imaginable)
Outcome measures
| Measure |
Normal Saline
n=22 Participants
Intraoperatively the patient will receive 10ml of normal saline injected into the sacrospinous ligament.
Normal Saline
|
Bupivacaine
n=24 Participants
Intraoperatively the patient will receive 10 ml of bupivacaine injected into the sacrospinous ligament.
Bupivacaine: Intraoperatively the patient will receive 10ml of bupivacaine injected into the sacrospinous ligament.
|
|---|---|---|
|
Postoperative Gluteal Pain
Mean gluteal pain in immediate post op
|
3.6 units on a scale
Standard Deviation 2.7
|
4.0 units on a scale
Standard Deviation 2.9
|
|
Postoperative Gluteal Pain
Mean gluteal pain within week 1 of procedure
|
2.0 units on a scale
Standard Deviation 2.4
|
2.0 units on a scale
Standard Deviation 2.6
|
|
Postoperative Gluteal Pain
Mean gluteal pain 2 weeks after procedure
|
1.1 units on a scale
Standard Deviation 1.3
|
1.0 units on a scale
Standard Deviation 1.1
|
|
Postoperative Gluteal Pain
Mean gluteal pain 4 weeks after procedure
|
0.3 units on a scale
Standard Deviation 0.5
|
0.3 units on a scale
Standard Deviation 0.4
|
|
Postoperative Gluteal Pain
Mean gluteal pain 6 weeks after procedure
|
0.1 units on a scale
Standard Deviation 0.3
|
0.1 units on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 6-weeksNeed for intervention through the use of trigger point injection, referral to pelvic floor physical therapy, or reoperation
Outcome measures
| Measure |
Normal Saline
n=22 Participants
Intraoperatively the patient will receive 10ml of normal saline injected into the sacrospinous ligament.
Normal Saline
|
Bupivacaine
n=24 Participants
Intraoperatively the patient will receive 10 ml of bupivacaine injected into the sacrospinous ligament.
Bupivacaine: Intraoperatively the patient will receive 10ml of bupivacaine injected into the sacrospinous ligament.
|
|---|---|---|
|
Need for Intervention for Postoperative Pain
Trigger point injection
|
0 participants
|
0 participants
|
|
Need for Intervention for Postoperative Pain
Referral to pelvic floor physical therapy
|
0 participants
|
0 participants
|
|
Need for Intervention for Postoperative Pain
Reoperation
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 weeksPain measured using the pain numeric rating scale from 0-10 (0=no pain, 10= worst pain imaginable)
Outcome measures
| Measure |
Normal Saline
n=22 Participants
Intraoperatively the patient will receive 10ml of normal saline injected into the sacrospinous ligament.
Normal Saline
|
Bupivacaine
n=24 Participants
Intraoperatively the patient will receive 10 ml of bupivacaine injected into the sacrospinous ligament.
Bupivacaine: Intraoperatively the patient will receive 10ml of bupivacaine injected into the sacrospinous ligament.
|
|---|---|---|
|
Overall Pain Beyond Day of Discharge
Mean overall pain 2 weeks after procedure
|
1.1 units on a scale
Standard Deviation 0.3
|
1.0 units on a scale
Standard Deviation 0.2
|
|
Overall Pain Beyond Day of Discharge
Mean overall pain 4 weeks after procedure
|
0.3 units on a scale
Standard Deviation 0.1
|
0.3 units on a scale
Standard Deviation 0.1
|
|
Overall Pain Beyond Day of Discharge
Mean overall pain 6 weeks after procedure
|
0.1 units on a scale
Standard Deviation 0.1
|
0.1 units on a scale
Standard Deviation 0.1
|
Adverse Events
Normal Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bupivacaine
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