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Intraperitoneal Infusion of Analgesic for Postoperative Pain Management

NCT04130464 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-09

No results posted yet for this study

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

Interventions

DRUG

Ropivacaine Infusion from ON-Q Pump

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

DRUG

Ropivacaine + Ketorolac Infusion from ON-Q Pump

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

DRUG

Normal Saline Infusion from ON-Q Pump

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

Sponsors & Collaborators

  • Avanos Medical

    collaborator OTHER

  • Ying Liu

    lead OTHER

Principal Investigators

  • Jennifer Keller, MD · Physician

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2026-09-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04130464 on ClinicalTrials.gov