NCT06842771

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: University of Tennessee · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Laparoscopic Adnexal Surgery

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-02-01
• Completion: 2027-03-01
• First posted: 2025-02-24
• Last updated: 2025-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study