RecruitingPhase 4

Intraperitoneal Infusion of Analgesic for Postoperative Pain Management

United States120 participantsStarted 2019-09-30

Plain-language summary

The study is a prospective, double-blinded, placebo-controlled multi-center trial to measure if postoperative pain and the amount of narcotics used are reduced by a clinically significant amount in women undergoing minimally invasive hysterectomy receiving a continuous infusion of intraperitoneal (IP) local anesthetic (LA) or a continuous infusion of LA combined with an NSAID compared with a control group who receives only 0.9% normal saline.

Who can participate

Age range

18 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Hysterectomy planned for a benign gynecologic reason (no evidence of, or concern for, malignancy in the cervix, uterus, tubes or ovaries. Benign gynecologic reasons to have a hysterectomy include fibroids, abnormal uterine bleeding, endometriosis, and pelvic pain.) * Patient is scheduled to have surgery with a fellowship trained minimally invasive gynecologic surgeons at one of the study sites. * Patient is planned for a robotic assisted total laparoscopic hysterectomy (RA-TLH) or a total laparoscopic hysterectomy (TLH). * Patient is capable of informed consent. * Patient is capable of completing the questionnaires. Exclusion Criteria: * Concern for malignancy * The procedure is scheduled outside MIGS department. * Allergy to any study related medication (i.e. Ketorolac and Ropivacaine) * Patient is enrolled in another pain management study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain Level 1 Hour Postoperative

Timeframe: 1 hour postoperative

Pain Level 2 Hours Postoperative

Timeframe: 2 hours postoperative

Pain Level 4 Hours Postoperative

Timeframe: 4 hours postoperative

Pain Level 6 Hours Postoperative

Timeframe: 6 hours postoperative

Pain Level 24 Hours Postoperative

Timeframe: 24 hours postoperative

Pain Level 48 Hours Postoperative

Timeframe: 48 hours postoperative

Pain Level 72 Hours Postoperative

Timeframe: 72 hours postoperative

Trial details

NCT IDNCT04130464

SponsorYing Liu

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09

Contact for this trial

Radwa Aly

202 677 6209 raly@mfa.gwu.edu

View on ClinicalTrials.gov More Hysterectomy trials