Vaginal Cuff Infiltration With Liposomal Bupivacaine for Pain Relief: A Double Blind, Randomized Controlled Trial

NCT05823363 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 2022-02-12
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The goal is to find out if Exparel (liposomal bupivacaine) given as an injection decreases pain score if given into the vaginal cuff right before starting the minimally invasive (robotic-assisted or laparoscopic) total hysterectomy in patients scheduled for benign indication? Participants will write down

1. 1.pain score at various intervals
2. 2.pain medication used Treatment patients will receive

Conditions

Postoperative Pain

Keywords

pain; bupivicaine; local infiltration

Outcome Measures

Primary Outcomes (1)

• Pain reduction after surgery

  A reduction in pain on a 11 point Likert Scale with 0 being no pain and 10 being very severe pain.

  72 hours after surgery

Study Arms (2)

Exparel and Bupivacaine Group

EXPERIMENTAL

The participants in this group will receive 10 ml of xxparel and 10 ml of bupivacaine in the vaginal cuff

Drug: Exparel with Bubivacaine

Bupivacaine Only Group

ACTIVE COMPARATOR

This group will receive 20ml of bupivicaine in the vaginal cuff

Drug: Bupivacaine only

Interventions

Exparel with Bubivacaine DRUG

10ml Exparel mixed with10ml bupivicaine in vaginal cuff

Exparel and Bupivacaine Group

Bupivacaine only DRUG

20ml of Bubivacaine in the vaginal cugg

Bupivacaine Only Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient age \> 18 years who is having minimally invasive robotic or laparoscopic total hysterectomy for any indication without any anesthetic block.

You may not qualify if:

• \) Use of any of the following medications within the times specified before surgery: a. opioid, SSRI, tricyclic antidepressant, gabapentin, pregabalin within three days of surgery. b. Use of acetaminophen within 24 hours of surgery 2) Concurrent painful physical condition or concurrent surgery that may require analgesic treatment (such as NSAID, opioid, SSRI, tricyclic antidepressant, gabapentin, pregabalin) in the postoperative period for pain that is not strictly related to the minimally invasive supracervical hysterectomy procedure and may confound the postoperative assessments (e.g., rheumatoid arthritis, chronic neuropathic pain.
• \) Chronic user of analgesic medications, including taking opioid medications for more than 14 days in the last 3 months, or nonopioid pain medications more than 5 times per week.
• \) Current use of systemic glucocorticosteroids (e.g. Decadron) or use of glucocorticoids within one month of enrollment into this study.
• \) History of hepatitis (other than hepatitis A). 6) History of hypersensitivity or idiosyncratic reactions to amide type local anesthetics, opioids, or propofol.
• \) Administration of an investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.
• \) Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance.
• \) Significant medical conditions or laboratory results that, in the opinion of the Investigator indicate an increased vulnerability to study drug and procedures, and expose subjects to an unreasonable risk as a result of participating in this clinical trial.
• \) Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postoperative course. 11) women with endometriosis 12) contraindications to any medication used in the study (acetaminophen, NSAID or opioid).

Sponsors & Collaborators

• Maimonides Medical Center: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Related Publications (1)

• Ishio J, Komasawa N, Kido H, Minami T. Evaluation of ultrasound-guided posterior quadratus lumborum block for postoperative analgesia after laparoscopic gynecologic surgery. J Clin Anesth. 2017 Sep;41:1-4. doi: 10.1016/j.jclinane.2017.05.015. Epub 2017 Jun 1.

  PMID: 28802593 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Scott Chudnoff, MD

  MMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: April 21, 2023
• Study Start: September 9, 2024
• Primary Completion: September 9, 2024
• Study Completion: September 9, 2024
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)