Local Anesthetics on Postsurgical Analgesia Following Posterior Colporrhaphy

NCT ID: NCT04032327

Last Updated: 2021-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2020-08-25

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Plain Bupivacaine

20 mL of 0.25% plain bupivacaine

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

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

Exparel plus plain bupivacaine

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

Group Type: ACTIVE_COMPARATOR

Exparel plus plain bupivacaine

Intervention Type: 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

Interventions

Exparel plus plain bupivacaine

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

Intervention Type: DRUG

Bupivacaine

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

Intervention Type: DRUG

Other Intervention Names

extended release liposomal bupivacaine plus marcaine; marcaine

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Walter Reed National Military Medical Center

FED

Sponsor Role: lead

Responsible Party

Katherine Dengler, MD

FPMRS Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Gruber, MD

Role: STUDY_CHAIR

Walter Reed National Military Medical Center (WRNMMC)

Locations

Walter Reed National Military Medical Center (WRNMMC)

Bethesda, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34473963 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

11111

Identifier Type: -

Identifier Source: org_study_id