Infusion of pain relief medication after minimally invasive hysterectomy
The Impact of the Continuous Infusion of Intraperitoneal Analgesics on Postoperative Pain After Minimally Invasive Hysterectomy: a Randomized Controlled Trial
This study is testing if a continuous infusion of pain relief medication can help women feel less pain after having a minimally invasive hysterectomy compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | George Washington University Academic / other |
| Locations | 2 sites (Washington D.C., District of Columbia and 1 other locations) |
| Trial ID | NCT04130464 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women scheduled for a minimally invasive hysterectomy for benign gynecologic conditions.
Not a fit: Patients with concerns for malignancy or allergies to study medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative pain and narcotic use, improving recovery for patients.
How similar studies have performed: Other studies have shown promising results with similar approaches to postoperative pain management, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Washington D.C., District of Columbia and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.