Recruiting

Intraperitoneal Infusion

Sponsor:

Ying Liu

Code:

NCT04130464

Conditions

Hysterectomy

Gynecologic Surgical Procedures

Narcotic Use

Pain, Postoperative

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Ropivacaine Infusion from ON-Q Pump

Ropivacaine + Ketorolac Infusion from ON-Q Pump

Normal Saline Infusion from ON-Q Pump

Study Details

Brief 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.

Conditions

Hysterectomy

Gynecologic Surgical Procedures

Narcotic Use

Pain, Postoperative

Study ID

NCT04130464

Start date

Sep 30, 2019

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ropivacaine

Subjects will receive a continuous intraperitoneal infusion of ropivacaine

experimental: Ropivacaine + Ketorolac

Subjects will receive a continuous intraperitoneal infusion of ropivacaine + ketorolac

placebo comparator: Normal Saline

Subjects will receive a continuous intraperitoneal infusion of normal saline

Interventions

Ropivacaine Infusion from ON-Q Pump

Infusion of 0.2% ropivacaine at 8 mL/hour for 72 hours

Ropivacaine + Ketorolac Infusion from ON-Q Pump

Infusion of 0.2% ropivacaine + 30 mg ketorolac at 8 mL/hour for 72 hours

Normal Saline Infusion from ON-Q Pump

Infusion of 0.9% normal saline at 8 mL/hour for 72 hours

Primary outcome measure

  • Pain Level 1 Hour Postoperative [ Time Frame: 1 hour postoperative ]
  • Pain Level 2 Hours Postoperative [ Time Frame: 2 hours postoperative ]
  • Pain Level 4 Hours Postoperative [ Time Frame: 4 hours postoperative ]
  • Pain Level 6 Hours Postoperative [ Time Frame: 6 hours postoperative ]
  • Pain Level 24 Hours Postoperative [ Time Frame: 24 hours postoperative ]
  • Pain Level 48 Hours Postoperative [ Time Frame: 48 hours postoperative ]
  • Pain Level 72 Hours Postoperative [ Time Frame: 72 hours postoperative ]

Central Contacts and Locations

Central contacts

Radwa Aly

202 677 6209raly@mfa.gwu.edu

Locations

MedStar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

James Robinson, MD

202-877-0526james.k.robinson@medstar.net

Principal Investigator:

James Robinson, MD

The GW Medical Faculty Associates

Recruiting

Washington D.C., District of Columbia, United States, 20037

Contacts

Jennifer Keller, MD

202 741 2524jkeller@mfa.gwu.edu

Principal Investigator:

Jennifer Keller, MD

More Information

Sponsor

Ying Liu

Last update posted

Apr 9, 2026

Last verified

Apr, 2026

Keywords

  • Intraperitoneal
  • Pain Pump
  • Ropivacaine
  • Ketorolac Tromethamine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ying Liu on 2026-04-09.