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Local Anesthetic

Analgesic Infusion for Postoperative Pain (ON-Q Trial)

Phase 4
Recruiting
Led By Gaby Moawad, MD
Research Sponsored by Ying Liu
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is planned for a robotic assisted total laparoscopic hysterectomy (RA-TLH) or a total laparoscopic hysterectomy (TLH).
Patient is scheduled to have surgery with a fellowship trained minimally invasive gynecologic surgeons at one of the study sites.
Must not have
Allergy to any study related medication (i.e. Ketorolac and Ropivacaine)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours postoperative
Awards & highlights
Drug Has Already Been Approved
Approved for 5 Other Conditions
Pivotal Trial
All Individual Drugs Already Approved

Summary

This trial will test if a continuous infusion of local anesthetic or local anesthetic combined with an NSAID can reduce postoperative pain and the amount of narcotics used compared to a control group who only receives saline.

Who is the study for?
This trial is for women undergoing minimally invasive hysterectomy without cancer concerns, who can consent and complete questionnaires. They must be having surgery with a trained surgeon at a study site and not be part of another pain study or allergic to the medications tested.
What is being tested?
The trial tests if post-surgery pain and narcotic use decrease significantly with an infusion of local anesthetic (LA) or LA plus NSAID from an ON-Q pump compared to saline. It's double-blinded, meaning neither patients nor researchers know who gets which treatment.
What are the potential side effects?
Possible side effects include reactions at the infusion site, potential nerve damage due to incorrect placement, allergic reactions to Ropivacaine or Ketorolac, bleeding issues from NSAIDs, and general discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a robotic or total laparoscopic hysterectomy.
Select...
I am scheduled for surgery with a specialized surgeon at a study site.
Select...
I am planning a hysterectomy for a non-cancerous condition like fibroids or endometriosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not allergic to Ketorolac or Ropivacaine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours postoperative
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours postoperative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain Level 1 Hour Postoperative
Pain Level 2 Hours Postoperative
Pain Level 24 Hours Postoperative
+4 more
Secondary study objectives
The total dose of analgesics taken over the 72 postoperative hours

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Ropivacaine + KetorolacExperimental Treatment1 Intervention
Subjects will receive a continuous intraperitoneal infusion of ropivacaine + ketorolac
Group II: RopivacaineExperimental Treatment1 Intervention
Subjects will receive a continuous intraperitoneal infusion of ropivacaine
Group III: Normal SalinePlacebo Group1 Intervention
Subjects will receive a continuous intraperitoneal infusion of normal saline

Find a Location

Who is running the clinical trial?

Ying LiuLead Sponsor
Avanos MedicalOTHER
8 Previous Clinical Trials
1,778 Total Patients Enrolled
George Washington UniversityLead Sponsor
252 Previous Clinical Trials
461,030 Total Patients Enrolled

Media Library

Ropivacaine Infusion from ON-Q Pump (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT04130464 — Phase 4
Postoperative Pain Research Study Groups: Normal Saline, Ropivacaine + Ketorolac, Ropivacaine
Postoperative Pain Clinical Trial 2023: Ropivacaine Infusion from ON-Q Pump Highlights & Side Effects. Trial Name: NCT04130464 — Phase 4
Ropivacaine Infusion from ON-Q Pump (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04130464 — Phase 4
~20 spots leftby Nov 2025
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