Local Anesthetics on Postsurgical Analgesia Following Posterior Colporrhaphy

NCT04032327 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 11111
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (3)

• 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

  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)

  Subjects will be asked to provide numerical values on postoperative day 1.

• 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

  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)

  Subjects will be asked to provide numerical values on postoperative day 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

  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)

  Subjects will be asked to provide numerical values on postoperative day 3.

Secondary Outcomes (9)

• Amount Ibuprofen Pain Medication Required During the Postoperative Period at Home

  Calculated with phone call on postoperative day 1, 2, and 3 (total acetaminophen utilized at home)

• Amount Acetaminophen Pain Medication Required During the Postoperative Period at Home

  Calculated with phone call on postoperative day 1, 2, and 3 (total acetaminophen utilized at home)

• Amount Opioid Pain Medication Required During the Postoperative Period (Through Day 3)

  Calculated throughout hospitalization and/or with phone call on postoperative day 1, 2, and 3 (total opioids utilized)

• Percentage of Participants Who Passed Active Voiding Trial Comparing the Bupivacaine Plus Exparel® Group Versus the Bupivacaine Plain Group.

  Postoperative active voiding trial on postoperative day 1.

• Rate of Post-operative Defecatory Function After Posterior Colporrhaphy, Comparing the Bupivacaine Plus Exparel® Group Versus the Bupivacaine Plain Group.

  Postoperatively up to day 3

Study Arms (2)

Plain Bupivacaine

ACTIVE COMPARATOR

20 mL of 0.25% plain bupivacaine

Drug: Bupivacaine

Exparel plus plain bupivacaine

ACTIVE COMPARATOR

10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed

Drug: Exparel plus plain bupivacaine

Interventions

Exparel plus plain bupivacaine DRUG

10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy

Also known as: extended release liposomal bupivacaine plus marcaine

Exparel plus plain bupivacaine

Bupivacaine DRUG

20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy

Also known as: marcaine

Plain Bupivacaine

Eligibility Criteria

• Age: 18 Years - 120 Years
• Gender Eligibility Details: females only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females \>18 years of age undergoing Urogynecologic surgery involving the posterior vaginal wall mucosa or muscularis including posterior colporrhaphy at Walter Reed National Military Medical Center.
• Patients must be able to read and understand written English or have an appropriate certified medical translator available.

You may not qualify if:

• Known allergy to amide local anesthetics.
• Unstable cardiac arrhythmia.
• Hepatic impairment (including but not limited to patients under the care of their physician for severe hepatic disease, cirrhosis or hepatic cancer).
• Known pregnancy at time of surgery (pregnancy test morning of surgery if applicable).
• Regular use of narcotic pain medication, defined as use on most days of week at any time in the three months prior to surgery.
• Significant history of opioid or alcohol abuse or addiction (requiring treatment).
• Concurrent pain management requiring the use of epidural anesthesia.

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

Study Sites (1)

Walter Reed National Military Medical Center (WRNMMC)

Bethesda, Maryland, 20889, United States

Location

Related Publications (1)

• Dengler KL, Craig ER, DiCarlo-Meacham AM, Welch EK, Brooks DI, Vaccaro CM, Gruber DD. Preoperative pudendal block with liposomal and plain bupivacaine reduces pain associated with posterior colporrhaphy: a double-blinded, randomized controlled trial. Am J Obstet Gynecol. 2021 Nov;225(5):556.e1-556.e10. doi: 10.1016/j.ajog.2021.08.034. Epub 2021 Aug 30.

  PMID: 34473963 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Katherine L Dengler, MD
• Organization: Walter Reed National Military Medical Center

katherine.l.dengler.mil@mail.mil

301-400-2468

Study Officials

• Daniel Gruber, MD

  Walter Reed National Military Medical Center (WRNMMC)

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FPMRS Fellow

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: July 25, 2019
• Study Start: July 1, 2018
• Primary Completion: August 25, 2020
• Study Completion: August 25, 2020
• Last Updated: November 18, 2021
• Results First Posted: November 18, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)