Pain with Differing Intraperitoneal Washes At the End of Laparoscopic Gynecologic Surgery

NCT06842771 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 24-10173-FB
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

We hypothesize that instilling intraperitoneal Marcaine (without epinephrine) at the end of a non-total laparoscopic gynecologic surgery (adnexa only, which includes the ovaries, fallopian tubes, and associated ligaments, vessels, and connective tissue) will result in less pain and reduced opioid use postoperatively.

Conditions

Laparoscopic Adnexal Surgery

Keywords

laparoscopic gynecologic surgery; adnexal laparoscopic surgery; ovarian laparoscopic surgery; fallopian tube laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• subjective pain scores

  At approximately 24 hours after surgery completion, we will contact the participant in person if still hospitalized, or via telephone if discharged home, to ask what their pain level is (utilizing the VAS) and how many opioid tablets (mg dosage and number) they have used since hospital discharge.

  At approximately 24 hours after surgery completion

Study Arms (2)

Normal saline intraperitoneal wash post procedure

ACTIVE COMPARATOR

The control group (standard care) will receive an intraperitoneal wash with a fixed amount of saline.

Other: Normal Saline (0.9% NaCl)

Marcaine hydrochloride without epinephrine 0.5% intraperitoneal wash

ACTIVE COMPARATOR

The experimental group (comparison treatment) will receive an intraperitoneal wash with 20 mL of Marcaine hydrochloride (bupivacaine) without epinephrine 0.5% at the end of surgery.

Drug: Marcaine hydrochloride without epinephrine 0.5%

Interventions

Normal Saline (0.9% NaCl) OTHER

Women will undergo planned, laparoscopic gynecologic surgery with an intraperitoneal wash of 20 mL of saline (standard) at the end of the operation, prior to insufflation, release, and skin closure. The wash will be instilled into the peritoneal cavity and the surgical area (over the vaginal cuff and along the bilateral pelvic sidewalls to the paracolic gutters). All participants will rate their pain using a Visual Analogue Scale (VAS). The VAS is a numerical rating system where the scores range from zero (0) to ten (10), with zero indicating 'no pain at all' and ten indicating 'the worst possible pain'. Participants will be asked to rate their current level of pain and also report their current dosage of pain medication at the following intervals: pre-operatively, 2 hours post-operatively, and 24 hours post-operatively.

Normal saline intraperitoneal wash post procedure

Marcaine hydrochloride without epinephrine 0.5% DRUG

Women will undergo planned, laparoscopic gynecologic surgery with an intraperitoneal wash of 20 mL Marcaine hydrochloride (bupivacaine) without epinephrine 0.5% (the comparator) at the end of the operation, prior to insufflation, release, and skin closure. The wash will be instilled into the peritoneal cavity and the surgical area (over the vaginal cuff and along the bilateral pelvic sidewalls to the paracolic gutters). All participants will rate their pain using a Visual Analogue Scale (VAS). The VAS is a numerical rating system where the scores range from zero (0) to ten (10), with zero indicating 'no pain at all' and ten indicating 'the worst possible pain'. Participants will be asked to rate their current level of pain and also report their current dosage of pain medication at the following intervals: pre-operatively, 2 hours post-operatively, and 24 hours post-operatively.

Marcaine hydrochloride without epinephrine 0.5% intraperitoneal wash

Eligibility Criteria

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

You may qualify if:

• Age 18 years and older
• Undergoing planned laparoscopic adnexal surgery as a day surgery procedure; The surgical site is the "adnexa" which contains the ovaries, fallopian tubes, and associated ligaments, vessels, and connective tissue. The "adnexa" does not include the uterus.
• BMI 55.0 or less

You may not qualify if:

• Under age 18
• Undergoing a non-laparoscopic unplanned surgical procedure Patients having a laparoscopic partial or complete removal of the uterus, a hysterectomy, will NOT be included in this study population for enrollment.
• septicemia
• severe hemorrhage
• severe hypotension or shock
• arrhythmias
• known hypersensitivity to bupivacaine or to any other local anesthetic agent
• local infection at the injection site

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (1)

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

John O. Schorge, MD

CONTACT

901-448-2531; jschorge@uthsc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: OB/GYN Chair and Professor

Model Details: Prospective, single-blind, randomized clinical trial in participants who are undergoing planned, laparoscopic gynecologic surgery (adnexa only- the ovaries, fallopian tubes, and associated ligaments, vessels \& connective tissue). A total of 96 women will be randomized to either the standard group or the comparator group. The control group (standard care) will receive an intraperitoneal wash with a fixed amount of saline. The experimental group (comparison treatment) will receive an intraperitoneal wash with an equal amount of pain medication. We have created a list of the participant counts; 1. 8 blocks of 12, divided into 6 each: control and experimental. 2. We have assigned a random number to each participant counted. 3. Then, we have sorted each block by the random numbers. This gives a random ordering to the 6 control and 6 experimental participants within each block of 12. We will assign each participant to a condition in order of this sorted list.

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 24, 2025
• Study Start: March 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)