120 Participants NeededMy employer runs this trial

Analgesic Infusion for Postoperative Pain

(ON-Q Trial)

Recruiting at 3 trial locations
RA
Overseen ByRadwa Aly
Age: 18+
Sex: Female
Trial Phase: Phase 4
Sponsor: Ying Liu
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special pain relief method can reduce pain and the need for narcotics after a minimally invasive hysterectomy. It will compare three groups: one receiving a regular saline solution, another receiving a local anesthetic (ropivacaine), and a third receiving both the anesthetic and an anti-inflammatory drug (ketorolac). Women planning to undergo a hysterectomy for non-cancerous reasons, such as fibroids or abnormal bleeding, might be suitable candidates. The trial seeks to find a better way to manage post-surgery pain. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these treatments?

Research has shown that ropivacaine is generally safe for adults to use for post-surgery pain. Patients often experience less pain and require fewer strong painkillers. Doses up to 800 mg over 24 hours have not raised major safety concerns.

Studies have also examined the combination of ropivacaine with ketorolac for post-surgery pain management. Administered through a pump, this combination helps maintain low pain levels. Research indicates that this method enhances pain relief without significant safety issues.

Overall, both treatments—ropivacaine alone and ropivacaine with ketorolac—are well-tolerated, with no major safety problems reported in the studies. These treatments are promising options for managing post-surgery pain.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for postoperative pain because they offer innovative approaches to pain management using continuous infusion. Unlike traditional oral or injectable pain medications, the ON-Q Pump delivers a steady, targeted infusion of ropivacaine, a local anesthetic, directly at the surgical site, potentially reducing the need for systemic opioids and their side effects. The addition of ketorolac, a nonsteroidal anti-inflammatory drug (NSAID), to ropivacaine in one of the treatment arms aims to enhance pain relief by combining anti-inflammatory effects with local anesthesia. This dual-action approach could provide more effective pain control and faster recovery compared to standard treatments, which often rely heavily on opioids.

What evidence suggests that this trial's treatments could be effective for postoperative pain?

Research has shown that ropivacaine effectively reduces pain after surgery and lessens the need for opioids. In this trial, some participants will receive a continuous intraperitoneal infusion of ropivacaine, which studies have found significantly improves pain control and speeds recovery. Another group will receive a combination of ropivacaine and ketorolac, offering even better pain relief and further reducing opioid use. This combination has proven more effective in managing pain than treatments without active ingredients. Overall, these treatments offer promising options for post-surgical pain management.12678

Who Is on the Research Team?

JK

Jennifer Keller, MD

Principal Investigator

Physician

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can fill out questionnaires by myself.
I am scheduled for a robotic or total laparoscopic hysterectomy.
I am scheduled for surgery with a specialized surgeon at a study site.
See 2 more

Exclusion Criteria

Patient is enrolled in another pain management study.
I am worried I might have cancer.
I am not allergic to Ketorolac or Ropivacaine.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants receive a continuous infusion of intraperitoneal analgesics or placebo for 72 hours post-surgery

72 hours
Inpatient stay

Immediate Postoperative Monitoring

Pain levels and analgesic use are monitored at 1, 2, 4, 6, 24, 48, and 72 hours postoperatively

72 hours

Follow-up

Participants complete a post-operative pain diary and are monitored for complications during a 2-week recovery period

2 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Normal Saline Infusion from ON-Q Pump
  • Ropivacaine Infusion from ON-Q Pump
  • Ropivacaine + Ketorolac Infusion from ON-Q Pump

Trial Overview

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.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Ropivacaine + KetorolacExperimental Treatment1 Intervention
Group II: RopivacaineExperimental Treatment1 Intervention
Group III: Normal SalinePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ying Liu

Lead Sponsor

Trials
1
Recruited
120+

George Washington University

Lead Sponsor

Trials
263
Recruited
476,000+

Avanos Medical

Collaborator

Trials
9
Recruited
1,900+

Citations

ON-Q Pump Infusion of Ketorolac and Ropivacaine at the ...

The primary aim of the present study is to evaluate the relative efficacy of the drugs Ketorolac and Ropivacaine infused through the ON-Q pump in reducing the ...

Postoperative Analgesia in TKA: Ropivacaine Continuous ...

Conclusions. Use of an infusion pump is effective in treating pain after TKA, reducing postoperative pain and opioid use. It also improves immediate ...

Postoperative Pain Control After Cesarean Section by ...

Postoperative Pain Control After Cesarean Section by Continuous Infusion Pump System Versus Ropivacaine Hydrogel: A Prospective Randomized Clinical Trial.

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31923061/

Ropivacaine and Ketorolac Wound Infusion for Post ...

Objective: To evaluate the efficacy of wound infusion with ropivacaine plus ketorolac compared with placebo for post-cesarean delivery analgesia in women who ...

The ON-Q pain management system in elective gynecology ...

This study revealed that the ON-Q pain management system is a more effective approach than IV PCA for acute postoperative surgical site pain relief.

Pain Effectiveness of continuous wound infusion of 0.5% ...

Patients who received a continuous surgical wound infusion of ropivacaine after surgical treatment had improved outcomes in terms of pain relief, lower morphine ...

A prospective randomized trial comparing the efficacy of ...

The total ketorolac administered over the 72 hours after surgery averaged 188.0 ± 84.6 mg for the Welpass group and 198.7 ± 50.0 mg for the On-Q ...

Efficacy of continuous preperitoneal ropivacaine infusion in ...

Pain was evaluated less than 8 h after surgery, POD 1 and POD 2: A, corresponding to the intensity of pain on visual analog scale(VAS, 0–10) ...