Trial Outcomes & Findings for Extended Release Local Anesthetic for Postsurgical Pain After Posterior Colporrhaphy and Perineorrhaphy (NCT NCT03875664)

NCT ID: NCT03875664

Last Updated: 2022-09-13

Results Overview

As measured by a 100 mm Visual Analog Scale (VAS). This scale ranges from 0-100 mm with 0 mm indicating no pain and 100 mm indicating the most pain. The study is powered to detect a decrease in postoperative pain by 20 mm on this scale, which is considered to be a clinically meaningful difference in prior studies. Results will be reported as mean pain scores at each time point (night of surgery, morning and evening for the first 72 hours after surgery, i.e. until postoperative day#3).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 72 participants
• Primary outcome timeframe: Night of surgery (POD#0), POD#1 morning, POD#1 evening, POD#2 morning, POD#2 evening, POD#3 morning, POD#3 evening
• Results posted on: 2022-09-13

Participant Flow

Excluded after enrollment if intraoperative decision made not to perform posterior colporrhaphy or perineorrhaphy.

Participant milestones

Measure	Intervention Receives 20 mL liposomal bupivacaine expanded with 10 mL of injectable sterile normal saline solution (0.9%) for a total of 30 mL injected in the posterior vaginal compartment in a standardized technique Liposomal bupivacaine: Extended-release local anesthetic	Placebo Receives 30 mL of injectable sterile normal 0.9% saline solution injected in the posterior vaginal compartment in a standardized technique Placebo - injection: Injectable normal saline solution
Overall Study STARTED	37	35
Overall Study COMPLETED	37	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Extended Release Local Anesthetic for Postsurgical Pain After Posterior Colporrhaphy and Perineorrhaphy

Baseline characteristics by cohort

Measure	Intervention n=37 Participants Receives 20 mL liposomal bupivacaine expanded with 10 mL of injectable sterile normal saline solution (0.9%) for a total of 30 mL injected in the posterior vaginal compartment in a standardized technique Liposomal bupivacaine: Extended-release local anesthetic	Placebo n=35 Participants Receives 30 mL of injectable sterile normal 0.9% saline solution injected in the posterior vaginal compartment in a standardized technique Placebo - injection: Injectable normal saline solution	Total n=72 Participants Total of all reporting groups
Age, Continuous	63.4 years STANDARD_DEVIATION 13.5 • n=5 Participants	61 years STANDARD_DEVIATION 26.7 • n=7 Participants	62.7 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	35 Participants n=7 Participants	72 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants	35 Participants n=7 Participants	71 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants	35 Participants n=7 Participants	69 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Night of surgery (POD#0), POD#1 morning, POD#1 evening, POD#2 morning, POD#2 evening, POD#3 morning, POD#3 evening

As measured by a 100 mm Visual Analog Scale (VAS). This scale ranges from 0-100 mm with 0 mm indicating no pain and 100 mm indicating the most pain. The study is powered to detect a decrease in postoperative pain by 20 mm on this scale, which is considered to be a clinically meaningful difference in prior studies. Results will be reported as mean pain scores at each time point (night of surgery, morning and evening for the first 72 hours after surgery, i.e. until postoperative day#3).

Outcome measures

Measure	Intervention n=37 Participants Receives 20 mL liposomal bupivacaine expanded with 10 mL of injectable sterile normal saline solution (0.9%) for a total of 30 mL injected in the posterior vaginal compartment in a standardized technique Liposomal bupivacaine: Extended-release local anesthetic	Placebo n=35 Participants Receives 30 mL of injectable sterile normal 0.9% saline solution injected in the posterior vaginal compartment in a standardized technique Placebo - injection: Injectable normal saline solution
Postoperative Pain POD#0 evening	1.9 mm Interval 0.0 to 2.4	1.3 mm Interval 0.0 to 4.3
Postoperative Pain POD#1 morning	2.0 mm Interval 0.0 to 4.1	1.9 mm Interval 0.0 to 3.4
Postoperative Pain POD#1 evening	2.9 mm Interval 0.0 to 4.9	2.5 mm Interval 0.0 to 3.5
Postoperative Pain POD#2 morning	3.1 mm Interval 0.0 to 6.5	2.4 mm Interval 0.0 to 4.6
Postoperative Pain POD#2 evening	2.3 mm Interval 0.0 to 6.6	1.9 mm Interval 0.0 to 4.2
Postoperative Pain POD#3 morning	1.7 mm Interval 0.0 to 3.5	1.9 mm Interval 0.0 to 3.4
Postoperative Pain POD#3 evening	2.3 mm Interval 0.0 to 4.9	1.6 mm Interval 0.0 to 4.6

SECONDARY outcome

Timeframe: 2 weeks after surgery

As measured by a 5-question satisfaction survey administered at a 2 week postoperative visit. The survey includes Likert scale responses ranging from very unsatisfied to very satisfied with the surgical experience and specifically analgesia. "Patient Satisfaction" was defined as response "satisfied" or "very satisfied" on the Likert Scale. Average responses will be reported.

Outcome measures

Measure	Intervention n=37 Participants Receives 20 mL liposomal bupivacaine expanded with 10 mL of injectable sterile normal saline solution (0.9%) for a total of 30 mL injected in the posterior vaginal compartment in a standardized technique Liposomal bupivacaine: Extended-release local anesthetic	Placebo n=35 Participants Receives 30 mL of injectable sterile normal 0.9% saline solution injected in the posterior vaginal compartment in a standardized technique Placebo - injection: Injectable normal saline solution
Number of Participants Reporting Satisfaction With Pain Control	32 Participants	33 Participants

SECONDARY outcome

Timeframe: Assessed up to 72 hours after surgery

Median time until first opioid administered after surgery

Outcome measures

Measure	Intervention n=37 Participants Receives 20 mL liposomal bupivacaine expanded with 10 mL of injectable sterile normal saline solution (0.9%) for a total of 30 mL injected in the posterior vaginal compartment in a standardized technique Liposomal bupivacaine: Extended-release local anesthetic	Placebo n=35 Participants Receives 30 mL of injectable sterile normal 0.9% saline solution injected in the posterior vaginal compartment in a standardized technique Placebo - injection: Injectable normal saline solution
Time to First Opioid Administration	89.5 minutes Interval 60.0 to 219.0	68 minutes Interval 60.0 to 234.0

SECONDARY outcome

Timeframe: Cumulatively, over a time period of 72 hours after surgery

Measured in milligram morphine equivalents

Outcome measures

Measure	Intervention n=37 Participants Receives 20 mL liposomal bupivacaine expanded with 10 mL of injectable sterile normal saline solution (0.9%) for a total of 30 mL injected in the posterior vaginal compartment in a standardized technique Liposomal bupivacaine: Extended-release local anesthetic	Placebo n=35 Participants Receives 30 mL of injectable sterile normal 0.9% saline solution injected in the posterior vaginal compartment in a standardized technique Placebo - injection: Injectable normal saline solution
Total Opioid Administration	37.5 mme Standard Deviation 40	37.5 mme Standard Deviation 43.5

SECONDARY outcome

Timeframe: Cumulatively, over a time period of 72 hours after surgery

Number of as-needed antiemetic doses patient received while in the hospital after surgery

Outcome measures

Measure	Intervention n=37 Participants Receives 20 mL liposomal bupivacaine expanded with 10 mL of injectable sterile normal saline solution (0.9%) for a total of 30 mL injected in the posterior vaginal compartment in a standardized technique Liposomal bupivacaine: Extended-release local anesthetic	Placebo n=35 Participants Receives 30 mL of injectable sterile normal 0.9% saline solution injected in the posterior vaginal compartment in a standardized technique Placebo - injection: Injectable normal saline solution
Number of Antiemetic Doses Required Per Participant While Inpatient	2 doses Interval 1.0 to 2.0	3 doses Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: Assessed until 30 days after surgery

Total length of hospital stay measured in hours, including readmissions

Outcome measures

Measure	Intervention n=37 Participants Receives 20 mL liposomal bupivacaine expanded with 10 mL of injectable sterile normal saline solution (0.9%) for a total of 30 mL injected in the posterior vaginal compartment in a standardized technique Liposomal bupivacaine: Extended-release local anesthetic	Placebo n=35 Participants Receives 30 mL of injectable sterile normal 0.9% saline solution injected in the posterior vaginal compartment in a standardized technique Placebo - injection: Injectable normal saline solution
Hospital Length of Stay	21.9 hours Standard Deviation 20	24 hours Standard Deviation 19.6

SECONDARY outcome

Timeframe: Assessed up to 72 hours after surgery

Total length of stay in PACU measured in minutes

Outcome measures

Measure	Intervention n=37 Participants Receives 20 mL liposomal bupivacaine expanded with 10 mL of injectable sterile normal saline solution (0.9%) for a total of 30 mL injected in the posterior vaginal compartment in a standardized technique Liposomal bupivacaine: Extended-release local anesthetic	Placebo n=35 Participants Receives 30 mL of injectable sterile normal 0.9% saline solution injected in the posterior vaginal compartment in a standardized technique Placebo - injection: Injectable normal saline solution
Length of Stay in Post-anesthesia Care Unit (PACU)	100 minutes Standard Deviation 61	93 minutes Standard Deviation 40

SECONDARY outcome

Timeframe: 72 hours after surgery

As recorded by patient - patients were asked each postoperative day (i.e. POD#0, POD#1, POD#2, POD#3) if they had a bowel movement that day, yes or no.

Outcome measures

Measure	Intervention n=37 Participants Receives 20 mL liposomal bupivacaine expanded with 10 mL of injectable sterile normal saline solution (0.9%) for a total of 30 mL injected in the posterior vaginal compartment in a standardized technique Liposomal bupivacaine: Extended-release local anesthetic	Placebo n=35 Participants Receives 30 mL of injectable sterile normal 0.9% saline solution injected in the posterior vaginal compartment in a standardized technique Placebo - injection: Injectable normal saline solution
Number of Participants Who Had a Bowel Movement Within the First 3 Postoperative Days	22 Participants	23 Participants

SECONDARY outcome

Timeframe: 2 weeks after surgery

Proportion of patients discharged home with Foley catheters after failed voiding trials in the hospital

Outcome measures

Measure	Intervention n=37 Participants Receives 20 mL liposomal bupivacaine expanded with 10 mL of injectable sterile normal saline solution (0.9%) for a total of 30 mL injected in the posterior vaginal compartment in a standardized technique Liposomal bupivacaine: Extended-release local anesthetic	Placebo n=35 Participants Receives 30 mL of injectable sterile normal 0.9% saline solution injected in the posterior vaginal compartment in a standardized technique Placebo - injection: Injectable normal saline solution
Voiding Trial Failures	15 Participants	19 Participants

SECONDARY outcome

Timeframe: Assessed until 30 days after surgery

Total adverse postoperative events

Outcome measures

Measure	Intervention n=37 Participants Receives 20 mL liposomal bupivacaine expanded with 10 mL of injectable sterile normal saline solution (0.9%) for a total of 30 mL injected in the posterior vaginal compartment in a standardized technique Liposomal bupivacaine: Extended-release local anesthetic	Placebo n=35 Participants Receives 30 mL of injectable sterile normal 0.9% saline solution injected in the posterior vaginal compartment in a standardized technique Placebo - injection: Injectable normal saline solution
Number of Patients With Adverse Events	6 Participants	11 Participants

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intervention n=37 participants at risk Receives 20 mL liposomal bupivacaine expanded with 10 mL of injectable sterile normal saline solution (0.9%) for a total of 30 mL injected in the posterior vaginal compartment in a standardized technique Liposomal bupivacaine: Extended-release local anesthetic	Placebo n=37 participants at risk；n=35 participants at risk Receives 30 mL of injectable sterile normal 0.9% saline solution injected in the posterior vaginal compartment in a standardized technique Placebo - injection: Injectable normal saline solution
Infections and infestations Urinary Tract Infections	10.8% 4/37 • Number of events 4 • 30 days We also investigated postoperative complications defined by the American College of Surgeon's National Surgical Quality Improvement Program (NSQIP). Adverse events were collected by chart review within 30 days of surgery. Charts were independently reviewed by 2 study personal for accuracy.	24.3% 9/37 • Number of events 9 • 30 days We also investigated postoperative complications defined by the American College of Surgeon's National Surgical Quality Improvement Program (NSQIP). Adverse events were collected by chart review within 30 days of surgery. Charts were independently reviewed by 2 study personal for accuracy.
Infections and infestations Hospital readmission	2.7% 1/37 • Number of events 1 • 30 days We also investigated postoperative complications defined by the American College of Surgeon's National Surgical Quality Improvement Program (NSQIP). Adverse events were collected by chart review within 30 days of surgery. Charts were independently reviewed by 2 study personal for accuracy.	2.7% 1/37 • Number of events 1 • 30 days We also investigated postoperative complications defined by the American College of Surgeon's National Surgical Quality Improvement Program (NSQIP). Adverse events were collected by chart review within 30 days of surgery. Charts were independently reviewed by 2 study personal for accuracy.
Infections and infestations Pneumonia	2.7% 1/37 • Number of events 1 • 30 days We also investigated postoperative complications defined by the American College of Surgeon's National Surgical Quality Improvement Program (NSQIP). Adverse events were collected by chart review within 30 days of surgery. Charts were independently reviewed by 2 study personal for accuracy.	0.00% 0/37 • 30 days We also investigated postoperative complications defined by the American College of Surgeon's National Surgical Quality Improvement Program (NSQIP). Adverse events were collected by chart review within 30 days of surgery. Charts were independently reviewed by 2 study personal for accuracy.
Surgical and medical procedures Return to operating room	0.00% 0/37 • 30 days We also investigated postoperative complications defined by the American College of Surgeon's National Surgical Quality Improvement Program (NSQIP). Adverse events were collected by chart review within 30 days of surgery. Charts were independently reviewed by 2 study personal for accuracy.	2.7% 1/37 • Number of events 1 • 30 days We also investigated postoperative complications defined by the American College of Surgeon's National Surgical Quality Improvement Program (NSQIP). Adverse events were collected by chart review within 30 days of surgery. Charts were independently reviewed by 2 study personal for accuracy.

Additional Information

Dr. Sarah Evans

Atrium Health

Phone: 704-304-1660

Email: sarah.evans@atriumhealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place