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

Conditions

• Laparoscopic Adnexal Surgery

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

Mar 31, 2025

Status verified

Feb 2025

Primary completion

Feb 28, 2026

Completion

Mar 31, 2027

Study Design

Enrollment

96 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Active Comparator: Normal saline intraperitoneal wash post procedure
  The control group (standard care) will receive an intraperitoneal wash with a fixed amount of saline.
• 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.

Primary Outcome Measure

subjective pain scores [ Time Frame: At approximately 24 hours after surgery completion ]

Central Contacts

• John O. Schorge, MD
  901-448-2531
  [email protected]

Locations (1)

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