Infusion of pain relief medication after minimally invasive hysterectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of continuous intraperitoneal infusion of local anesthetic and NSAID for managing postoperative pain in women undergoing minimally invasive hysterectomy. Participants will be randomly assigned to receive either a local anesthetic, a combination of local anesthetic and NSAID, or a placebo. The study aims to determine if these interventions can significantly reduce pain and the need for narcotics post-surgery compared to a control group receiving saline. The trial will involve multiple centers and will utilize a double-blinded, placebo-controlled design to ensure unbiased results.

Why it matters

Who can join: the full rules

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.

Where it's running

• MedStar Washington Hospital Center
  Washington D.C., District of Columbia, United States Recruiting
• The GW Medical Faculty Associates
  Washington D.C., District of Columbia, United States Recruiting

Study contacts

• Principal investigator: Jennifer Keller, MD — Physician
• Study coordinator: Radwa Aly
• Email: raly@mfa.gwu.edu
• Phone: 202 677 6209

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Biofeedback-Assisted Pelvic Floor Training After Hysterectomy

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• Single-level vs two-level erector spinae plane block for breast surgery

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.