Actively Recruiting
The Impact of the Continuous Infusion of Intraperitoneal Analgesics on Postoperative Pain After Minimally Invasive Hysterectomy: A Randomized Controlled Trial
Led by Ying Liu · Updated on 2026-04-09
120
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
Sponsors
Y
Ying Liu
Lead Sponsor
A
Avanos Medical
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating if continuous infusion of intraperitoneal local anesthetic (LA), alone or combined with an NSAID, can reduce postoperative pain and narcotic use in women undergoing minimally invasive hysterectomy. This randomized, double-blinded, placebo-controlled trial compares these treatments to a placebo infusion in women planned for robotic-assisted or total laparoscopic hysterectomy for benign gynecologic reasons. The study focuses on women aged 18 to 65 undergoing this surgery with experienced minimally invasive gynecologic surgeons.
CONDITIONS
Brief Title
Intraperitoneal Infusion of Analgesic for Postoperative Pain Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Planned hysterectomy for a benign gynecologic reason with no concern for malignancy
- Scheduled surgery with a fellowship-trained minimally invasive gynecologic surgeon at a study site
- Planned robotic-assisted total laparoscopic hysterectomy (RA-TLH) or total laparoscopic hysterectomy (TLH)
- Ability to provide informed consent
- Ability to complete questionnaires
You will not qualify if you...
- Concern for malignancy
- Procedure scheduled outside the minimally invasive gynecologic surgery department
- Allergy to ketorolac or ropivacaine
- Enrollment in another pain management study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 2 weeks before surgery
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during pre-surgery clinic visit
Duration - 72 hours
Participants undergo minimally invasive hysterectomy surgery and receive a continuous intraperitoneal infusion of assigned medication (ropivacaine, ropivacaine with ketorolac, or placebo) via an ON-Q pump for 72 hours following surgery.
Hospital stay usually same day discharge with catheter removal instructions if discharged earlier; continuous infusion pump administered during this period
Duration - Approximately 2 weeks
Participants complete a pain diary and quality of life questionnaire during their 2-week recovery period. They return for a post-operative visit to review pain, medication use, and any complications.
1 follow-up visit at around 2 weeks postoperatively
Trial Site Locations
Total: 2 locations
1
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
2
The GW Medical Faculty Associates
Washington D.C., District of Columbia, United States, 20037
Actively Recruiting
Research Team
R
Radwa Aly
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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