Managing Pain After Hysterectomy with Intraperitoneal Infusion

This study is looking at ways to reduce pain and the need for strong pain medications (narcotics) after a hysterectomy (surgery to remove the uterus). You might be eligible if you are a woman between 18 and 65 years old, planning a minimally invasive hysterectomy for a non-cancerous reason like fibroids or endometriosis. The study will compare three different treatments given directly into the abdomen (intraperitoneal) using a special pump for 72 hours after surgery: ropivacaine, a combination of ropivacaine and ketorolac (an anti-inflammatory drug), or a saline solution (placebo). Researchers will measure your pain levels at 1, 2, and 4 hours after surgery to see if these treatments are effective. The study aims to find out if these infusions can significantly lower your pain and narcotic use.

Study design
This is a prospective, double-blinded, placebo-controlled study involving 120 participants. Participants will be randomly assigned to one of three treatment groups.
What's involved
You will complete a health-related quality of life questionnaire before surgery. After surgery, you will receive an infusion for 72 hours, and your pain levels will be measured at 1, 2, and 4 hours post-operation.
Compensation
Not stated in the trial record.
Follow-up
Your pain levels will be measured at 1, 2, and 4 hours after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04130464

Intraperitoneal Infusion of Analgesic for Postoperative Pain Management

Recruiting
PHASE4Ages 18–65InterventionalTreatment
Ying Liu
~120 participants
Updated 2026-04-09 on ClinicalTrials.gov
What's tested:Ropivacaine Infusion from ON-Q PumpRopivacaine + Ketorolac Infusion from ON-Q PumpNormal Saline Infusion from ON-Q Pump

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain Level 1 Hour Postoperative
Measured over 1 hour postoperative
+6 more outcomes measured
Hysterectomy
Gynecologic Surgical Procedures
Narcotic Use
Pain, Postoperative

NCT04130464

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbiastudy coordinator listed

    Recruiting

  • The GW Medical Faculty Associates

    Washington D.C., District of Columbiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Jennifer Keller, MD · PRINCIPAL_INVESTIGATOR · Physician

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Eligibility criteria

Inclusion

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

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.
  • Pain Level 1 Hour Postoperative1 hour postoperative

    Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"

  • Pain Level 2 Hours Postoperative2 hours postoperative

    Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"

  • Pain Level 4 Hours Postoperative4 hours postoperative

    Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"

  • Pain Level 6 Hours Postoperative6 hours postoperative

    Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"

  • Pain Level 24 Hours Postoperative24 hours postoperative

    Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"

  • Pain Level 48 Hours Postoperative48 hours postoperative

    Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"

  • Pain Level 72 Hours Postoperative72 hours postoperative

    Rating from 0 "No pain sensation" to 10 "most intense pain imaginable"