NCT03875664

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

Completed Phase 4 Results posted Last updated 13 September 2022

What this trial tests

Phase 4 trial testing Liposomal bupivacaine in Postoperative Pain in 72 participants. Completed in 31 March 2019.

Timeline

23 July 2018

Primary endpoint
12 March 2019

31 March 2019

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	72
Start date	23 July 2018
Primary completion	12 March 2019
Estimated completion	31 March 2019
Sites	1 location across United States

Drugs / interventions tested

• Liposomal bupivacaine — full drug profile →
• Placebo - injection

Conditions studied

• Postoperative Pain — all drugs for Postoperative Pain →

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, female only, with Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Postoperative Pain Primary · 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).

POD#0 evening

Group	Value	95% CI
Intervention	1.9	0 – 2.4
Placebo	1.3	0 – 4.3

POD#1 morning

Group	Value	95% CI
Intervention	2.0	0 – 4.1
Placebo	1.9	0 – 3.4

POD#1 evening

Group	Value	95% CI
Intervention	2.9	0 – 4.9
Placebo	2.5	0 – 3.5

POD#2 morning

Group	Value	95% CI
Intervention	3.1	0 – 6.5
Placebo	2.4	0 – 4.6

POD#2 evening

Group	Value	95% CI
Intervention	2.3	0 – 6.6
Placebo	1.9	0 – 4.2

POD#3 morning

Group	Value	95% CI
Intervention	1.7	0 – 3.5
Placebo	1.9	0 – 3.4

POD#3 evening

Group	Value	95% CI
Intervention	2.3	0 – 4.9
Placebo	1.6	0 – 4.6

Number of Participants Reporting Satisfaction With Pain Control Secondary · 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.

Group	Value	95% CI
Intervention	32
Placebo	33

Time to First Opioid Administration Secondary · Assessed up to 72 hours after surgery

Median time until first opioid administered after surgery

Group	Value	95% CI
Intervention	89.5	60 – 219
Placebo	68	60 – 234

Total Opioid Administration Secondary · Cumulatively, over a time period of 72 hours after surgery

Measured in milligram morphine equivalents

Group	Value	95% CI
Intervention	37.5	± 40
Placebo	37.5	± 43.5

Number of Antiemetic Doses Required Per Participant While Inpatient Secondary · Cumulatively, over a time period of 72 hours after surgery

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

Group	Value	95% CI
Intervention	2	1 – 2
Placebo	3	1 – 3

Hospital Length of Stay Secondary · Assessed until 30 days after surgery

Total length of hospital stay measured in hours, including readmissions

Group	Value	95% CI
Intervention	21.9	± 20
Placebo	24	± 19.6

Length of Stay in Post-anesthesia Care Unit (PACU) Secondary · Assessed up to 72 hours after surgery

Total length of stay in PACU measured in minutes

Group	Value	95% CI
Intervention	100	± 61
Placebo	93	± 40

Number of Participants Who Had a Bowel Movement Within the First 3 Postoperative Days Secondary · 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.

Group	Value	95% CI
Intervention	22
Placebo	23

Voiding Trial Failures Secondary · 2 weeks after surgery

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

Group	Value	95% CI
Intervention	15
Placebo	19

Number of Patients With Adverse Events Secondary · Assessed until 30 days after surgery

Total adverse postoperative events

Group	Value	95% CI
Intervention	6
Placebo	11

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention

Serious: 0/37 (0%)

Deaths: 0/37

Placebo

Serious: 0/35 (0%)

Deaths: 0/35

Other adverse events (4 terms — click to expand)

Reaction	System	Intervention	Placebo
Urinary Tract Infections	Infections and infestations	—	—
Hospital readmission	Infections and infestations	—	—
Pneumonia	Infections and infestations	—	—
Return to operating room	Surgical and medical procedures	—	—

Data from ClinicalTrials.gov NCT03875664 adverse events section.

Sponsor's own description

The specific aim of this randomized double-blind clinical trial is to evaluate the effect of intraoperative infiltration of liposomal bupivacaine at the time of posterior colporrhaphy and/or perineorrhaphy on postsurgical pain scores during the first 72 hours after surgery as measured by visual analog scales (VAS) for patients undergoing surgery for pelvic organ prolapse. Study subjects are randomized to 30 mL of liposomal bupivacaine versus 30 mL of injectable normal saline administered in a standardized technique into the posterior vaginal compartment at the time of posterior repair and/or perineorrhaphy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.