Clinical trial NCT06842771: Pain with Differing Intraperitoneal Washes At the End of Laparoscopic Gynecologic Surgery
Official title: Pain with Differing Intraperitoneal Washes At the End of Laparoscopic Gynecologic Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Laparoscopic Adnexal Surgery
Keywords: laparoscopic gynecologic surgery
adnexal laparoscopic surgery
ovarian laparoscopic surgery
fallopian tube laparoscopic surgery
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: subjective pain scores
timeFrame: At approximately 24 hours after surgery completion
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
Study officials:
References: