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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours postoperative
Awards & highlights

ON-Q Trial 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.Check my eligibility
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.See study design
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.

ON-Q Trial 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.

ON-Q Trial 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

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

ON-Q 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
243 Previous Clinical Trials
453,654 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other empirical experiments have been performed with regard to Ropivacaine Infusion from ON-Q Pump?

"Currently, there are 101 clinical trials actively researching the efficacy of Ropivacaine Infusion from ON-Q Pump with 22 in Phase 3. These studies can be found at 138 locations around the world, though a majority have their base of operations situated in Boston."

Answered by AI

How many participants are signed up for this research study?

"Affirmative. Clinicaltrials.gov documents that recruiting for this medical trial, which was initially posted on September 30th 2019, is currently in progress. The study requires 120 individuals to be enrolled across two distinct sites."

Answered by AI

Do I meet the criteria to be a participant in this clinical research?

"To be eligible for this trial, participants must demonstrate postoperative pain and are required to fall within the age range of 18-65. The clinical team is currently recruiting approximately 120 individuals."

Answered by AI

How does the ON-Q Pump with Ropivacaine Infusion affect human health?

"The safety rating of Ropivacaine Infusion from ON-Q Pump is 3, as the treatment has already been approved after multiple rounds of trials."

Answered by AI

Does this research accept participants aged 55 or older?

"The cutoff for eligible participants in this trial is 65 years of age, with a minimum requirement of 18 years."

Answered by AI

What medical maladies can be addressed with Ropivacaine Infusion from ON-Q Pump?

"The preferred method of treating pericarditis acute is Ropivacaine Infusion from ON-Q Pump, as well assisting with ocular itching, pain control and establishing nerve block."

Answered by AI

Are there any vacancies for the clinical experiment at this time?

"Affirmative. According to clinicaltrials.gov, this experiment is actively recruiting test subjects; it was first posted on September 30th 2019 and recently updated on October 10 2022. Presently, 120 prospective participants are required from two distinct medical sites."

Answered by AI
~8 spots leftby Sep 2024