Intraperitoneal Infusion of Analgesic for Postoperative Pain Management

NCT04130464 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 180423
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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

Keywords

Intraperitoneal; Pain Pump; Ropivacaine; Ketorolac Tromethamine

Outcome Measures

Primary Outcomes (7)

• Pain Level 1 Hour Postoperative

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

  1 hour postoperative

• Pain Level 2 Hours Postoperative

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

  2 hours postoperative

• Pain Level 4 Hours Postoperative

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

  4 hours postoperative

• Pain Level 6 Hours Postoperative

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

  6 hours postoperative

• Pain Level 24 Hours Postoperative

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

  24 hours postoperative

• Pain Level 48 Hours Postoperative

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

  48 hours postoperative

• Pain Level 72 Hours Postoperative

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

  72 hours postoperative

Secondary Outcomes (1)

• The total dose of analgesics taken over the 72 postoperative hours

  Within 72 hours postoperative

Study Arms (3)

Ropivacaine

EXPERIMENTAL

Subjects will receive a continuous intraperitoneal infusion of ropivacaine

Drug: Ropivacaine Infusion from ON-Q Pump

Ropivacaine + Ketorolac

EXPERIMENTAL

Subjects will receive a continuous intraperitoneal infusion of ropivacaine + ketorolac

Drug: Ropivacaine + Ketorolac Infusion from ON-Q Pump

Normal Saline

PLACEBO COMPARATOR

Subjects will receive a continuous intraperitoneal infusion of normal saline

Drug: Normal Saline Infusion from ON-Q Pump

Interventions

Ropivacaine Infusion from ON-Q Pump DRUG

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

Also known as: Naropin

Ropivacaine

Ropivacaine + Ketorolac Infusion from ON-Q Pump DRUG

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

Also known as: Naropin, Toradol

Ropivacaine + Ketorolac

Normal Saline Infusion from ON-Q Pump DRUG

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

Also known as: Saline solution

Normal Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ying Liu: lead
• Avanos Medical: collaborator

Study Sites (2)

MedStar Washington Hospital Center

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

RECRUITING

The GW Medical Faculty Associates

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

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Ketorolac Tromethamine; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jennifer Keller, MD

  Physician

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Radwa Aly

CONTACT

202 677 6209; raly@mfa.gwu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study; the surgeon and the patient will not know which study group they are a part of. Only the IDS pharmacist and IDS pharmacy technician will know which group each study patient has been assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 17, 2019
• Study Start: September 30, 2019
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (2)