NCT04032327

Local Anesthetics on Postsurgical Analgesia Following Posterior Colporrhaphy

Completed Phase 2 Results posted Last updated 18 November 2021

What this trial tests

Phase 2 trial testing Exparel plus plain bupivacaine in Postoperative Pain in 120 participants. Completed in 25 August 2020.

Timeline

1 July 2018

Primary endpoint
25 August 2020

25 August 2020

Quick facts

Lead sponsor	Walter Reed National Military Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	120
Start date	1 July 2018
Primary completion	25 August 2020
Estimated completion	25 August 2020
Sites	1 location across United States

Drugs / interventions tested

• Exparel plus plain bupivacaine — full drug profile →
• Bupivacaine (BUPIVACAINE) — full drug profile →

Conditions studied

• Postoperative Pain — all drugs for Postoperative Pain →

Sponsor

Walter Reed National Military Medical Center

Who can join

Adults 18 to 120, 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.

Change in Vaginal Pain Scores Using the Defense and Veterans Pain Rating Scale (Visual Analog Scale) Between Bupivacaine Alone Versus Exparel® Following Posterior Colporrhaphy Post-operatively Primary · Subjects will be asked to provide numerical values on postoperative day 1.

Patients will be asked on postoperative day (POD) 1 to provide numerical values regarding vaginal pain from 0-10 (zero being no pain and 10 being the worst pain) utilizing the Defense and Veterans Pain Rating Scale (visual analog scale)

Group	Value	95% CI
Plain Bupivacaine	2	0 – 4
Exparel Plus Plain Bupivacaine	0	0 – 2

Change in Vaginal Pain Scores Using the Defense and Veterans Pain Rating Scale (Visual Analog Scale) Between Bupivacaine Alone Versus Exparel® Following Posterior Colporrhaphy Post-operatively Primary · Subjects will be asked to provide numerical values on postoperative day 2.

Patients will be asked on postoperative day (POD) 2 to provide numerical values for vaginal pain from 0-10 (zero being no pain and 10 being the worst pain) utilizing the Defense and Veterans Pain Rating Scale (visual analog scale)

Group	Value	95% CI
Plain Bupivacaine	3	2 – 5
Exparel Plus Plain Bupivacaine	2	1 – 4

Change in Vaginal Pain Scores Using the Defense and Veterans Pain Rating Scale (Visual Analog Scale) Between Bupivacaine Alone Versus Exparel® Following Posterior Colporrhaphy Post-operatively Primary · Subjects will be asked to provide numerical values on postoperative day 3.

Patients will be asked on postoperative day (POD) 3 to provide numerical values for vaginal pain from 0-10 (zero being no pain and 10 being the worst pain) utilizing the Defense and Veterans Pain Rating Scale (visual analog scale)

Group	Value	95% CI
Plain Bupivacaine	3	2 – 5
Exparel Plus Plain Bupivacaine	2	1 – 4

Amount Ibuprofen Pain Medication Required During the Postoperative Period at Home Secondary · Calculated with phone call on postoperative day 1, 2, and 3 (total acetaminophen utilized at home)

Calculate total postoperative ibuprofen used while at home via perform pill counts on postoperative days 1, 2, 3 (done via a phone call). This will allow calculation of total amount of ibuprofen utilized at home through postoperative day #3

Group	Value	95% CI
Plain Bupivacaine	3600	2400 – 4800
Exparel Plus Plain Bupivacaine	2400	0 – 4050

Amount Acetaminophen Pain Medication Required During the Postoperative Period at Home Secondary · Calculated with phone call on postoperative day 1, 2, and 3 (total acetaminophen utilized at home)

Calculate total postoperative acetaminophen used while at home via perform pill counts on postoperative days 1, 2, 3 (done via a phone call). This will allow calculation of total amount of acetaminophen utilized at home through postoperative day #3

Group	Value	95% CI
Plain Bupivacaine	4000	2110 – 5930
Exparel Plus Plain Bupivacaine	3250	1300 – 4550

Amount Opioid Pain Medication Required During the Postoperative Period (Through Day 3) Secondary · Calculated throughout hospitalization and/or with phone call on postoperative day 1, 2, and 3 (total opioids utilized)

Calculate total postoperative opioid medications used while inpatient and perform pill counts on postoperative days 1, 2, 3 (done via a phone call or inpatient). This will allow calculation of total amount of opioid pain medications utilized through postoperative day #3

Group	Value	95% CI
Plain Bupivacaine	45.0	22.5 – 118
Exparel Plus Plain Bupivacaine	57.1	30.0 – 93.5

Percentage of Participants Who Passed Active Voiding Trial Comparing the Bupivacaine Plus Exparel® Group Versus the Bupivacaine Plain Group. Secondary · Postoperative active voiding trial on postoperative day 1.

Investigators will record in patients passed active voiding trail prior to discharge home.

Group	Value	95% CI
Plain Bupivacaine	82
Exparel Plus Plain Bupivacaine	72

Rate of Post-operative Defecatory Function After Posterior Colporrhaphy, Comparing the Bupivacaine Plus Exparel® Group Versus the Bupivacaine Plain Group. Secondary · Postoperatively up to day 3

Investigators will record in patients have had a bowel movement within the first three days postoperatively.

Group	Value	95% CI
Plain Bupivacaine	71.6
Exparel Plus Plain Bupivacaine	73.3

Impact of Vaginal Pain Scores on Quality of Life Measures (ACTIVITY) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group Secondary · Subjects will be asked to provide numerical value on postoperative day 3.

Investigators will ask patients "how is your vaginal pain impacting your ACTIVITY (quality of life question)" and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3

Group	Value	95% CI
Plain Bupivacaine	3.5	0.250 – 6
Exparel Plus Plain Bupivacaine	3	0.500 – 5

Impact of Vaginal Pain Scores on Quality of Life Measure (SLEEP) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group Secondary · Subjects will be asked to provide numerical value on postoperative day 3.

Investigators will ask patients "how is your vaginal pain impacting your SLEEP (quality of life question)" and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3

Group	Value	95% CI
Plain Bupivacaine	0.500	0 – 3
Exparel Plus Plain Bupivacaine	1	0 – 3

Impact of Vaginal Pain Scores on Quality of Life Measure (MOOD) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group Secondary · Subjects will be asked to provide numerical value on postoperative day 3.

Investigators will ask patients "how is your vaginal pain impacting your MOOD (quality of life question)" and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3

Group	Value	95% CI
Plain Bupivacaine	1	0 – 3
Exparel Plus Plain Bupivacaine	1	0 – 3

Impact of Vaginal Pain Scores on Quality of Life Measure (STRESS) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group Secondary · Subjects will be asked to provide numerical value on postoperative day 3.

Investigators will ask patients "how is your vaginal pain impacting your STRESS (quality of life question)" and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3

Group	Value	95% CI
Plain Bupivacaine	0	0 – 3
Exparel Plus Plain Bupivacaine	1	0 – 3

Adverse events — posted to ClinicalTrials.gov

Time frame: entirety of the study (AUG2018-AUG2020); patients were followed out to 6 weeks postoperatively. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Plain Bupivacaine

Serious: 0/60 (0%)

Deaths: 0/60

Exparel Plus Plain Bupivacaine

Serious: 0/60 (0%)

Deaths: 0/60

Other adverse events (1 terms — click to expand)

Reaction	System	Plain Bupivacaine	Exparel Plus Plain Bupivac…
Postoperative sensory numbness/tingling in the lower extremities	Musculoskeletal and connective tissue disorders	—	—

Data from ClinicalTrials.gov NCT04032327 adverse events section.

Sponsor's own description

Effective post-surgical pain management is a crucial component of a patient's postoperative course following posterior colporrhaphy. Narcotics are the cornerstone for postoperative analgesia with a frequent re-dosing requirement, a lengthy list of side effects and adverse reaction risks. The colorectal, orthopedic and general surgery literatures have reported on an extended-release bupivacaine liposomal injection, Exparel®, which remarkably reduces acute post-operative pain; however, literature regarding this medication specific to Urogynecology and Gynecology is limited.

The investigators propose a prospective, randomized, double blind, trial with 120 subjects recruited from the Walter Reed National Military Medical Center (WRNMMC) Urogynecology Clinic to study postsurgical pain control after posterior repair. There will be two arms in the study; one arm with bupivacaine alone and a second arm with bupivacaine mixed with Exparel®(extended-release, liposomal bupivacaine) injected vaginally in patients undergoing posterior colporrhaphy. Subjects will be randomized to receive either 20 milliliter (mL) of plain bupivacaine or 20mL (10ml+10ml) mixture of bupivacaine plus Exparel®.

The primary objective of the trial will be to evaluate the postsurgical vaginal pain using a visual analog pain scale at days 1, 2, 3 post-procedure. All subjects will have acetaminophen, a non-steroidal anti-inflammatory drug and narcotic pain medication available for pain control regardless of assignment, which is the usual postoperative pain control regimen. The investigators hypothesize a 30% difference in post-operative pain measurements between the two groups.

Additional objectives of this study are to evaluate total medication usage on days 1, 2 and 3 and any post-operative voiding and defecatory dysfunction, comparing the two groups

Publications & conference data

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