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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Laparoscopic Adnexal Surgery
• Intervention / Treatment: Other: Normal Saline (0.9% NaCl); Drug: Marcaine hydrochloride without epinephrine 0.5%

Detailed Description

Minimally invasive gynecologic surgery has been shown to reduce postoperative pain, length of hospital stay, and prescription opioid use when compared to open procedures. However, postoperative abdominal pain is still significant, and the ways in which this pain can be reduced requires further exploration.

It is standard procedure to inject the surgical incision sites with long-acting analgesics such as Marcaine or Ropivacaine. However, intraperitoneal instillation of these pain medications and their effect on postoperative pain and prescription opioid use has only minimally been explored thus far.

In a retrospective cohort study, the effectiveness of administering intraperitoneal bupivacaine on decreasing postoperative pain in patients undergoing minimally invasive gynecologic surgery was evaluated. For the 130 patients included in the study, those who received the intraperitoneal bupivacaine "had lower median narcotic use on the day of surgery and the first postoperative day, compared with those who did not receive intraperitoneal bupivacaine".

Given these results, we believe that it will be beneficial to include the use of intraperitoneal anesthetics for patients receiving laparoscopic gynecologic surgery (adnexa only, which includes the ovaries, fallopian tubes, and associated ligaments, vessels, and connective tissue).

Marcaine hydrochloride (bupivacaine) without epinephrine 0.5% was chosen for this study because this was used in previous studies, and it is used for analgesia at the trocar incisions during the laparoscopic procedure. The extra Marcaine hydrochloride (bupivacaine) without epinephrine 0.5% will, therefore, be available for use instead of being discarded. The use of Marcaine hydrochloride (bupivacaine) without epinephrine 0.5% will not incur any additional cost. Similarly, normal saline is used routinely during these types of surgical procedures, is available post-operatively for use as an intraperitoneal wash instead of being discarded. The participants will be randomized to Marcaine hydrochloride (bupivacaine) without epinephrine 0.5% or normal saline.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: John O. Schorge, MD; Phone Number: 901-448-2531; Email: jschorge@uthsc.edu

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38163
      • University of Tennessee Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Normal saline intraperitoneal wash post procedure; The control group (standard care) will receive an intraperitoneal wash with a fixed amount of saline.	Other: Normal Saline (0.9% NaCl); 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.
Active Comparator: Marcaine hydrochloride without epinephrine 0.5% intraperitoneal wash; 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%; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Tennessee

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: laparoscopic gynecologic surgery; adnexal laparoscopic surgery; ovarian laparoscopic surgery; fallopian tube laparoscopic surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Neurotransmitter Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Bupivacaine; Epinephrine
• Other Study ID Numbers: 24-10173-FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No