Infusion Pump for Postoperative Pain

Overseen By Charles Gatt, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Rutgers, The State University of New Jersey

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will be a pragmatic, prospective cluster randomized trial, where clusters will formed based on sequential 2 week time increments across the study recruitment period.. Patients 18 years or older undergoing ACL reconstruction, open shoulder labrum or rotator cuff surgery, arthroscopic rotator cuff repair, proximal or distal patellar realignment surgery, open knee arthrotomy cases (i.e. inside out meniscus repair, osteochondral allograft transplantation (OCA), meniscal allograft transplantation (MAT)) at University Center for Ambulatory Surgery, LLC (UOA) will be reviewed for eligibility. Once identified, potential study subjects will be asked whether they are interested in participating in the project. If the patient agrees, the subject will be given the informed consent to read and sign.

Objectives: The primary objective is to compare the effectiveness of postoperative infusion pain pump versus preoperative nerve block in reducing visual analog pain scores/numerical pain rating scale (VAS/NPRS) in the postoperative period. The second objective is to evaluate the requirement of narcotic and non-narcotic analgesic medications between the two groups.

Hypotheses: Use of continuous infusion pain pump or single shot peripheral block will result in similar post-operative pain control after outpatient sports medicine surgical cases.

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are undergoing specific surgeries like ACL reconstruction, shoulder labrum or rotator cuff surgery, and certain knee operations at the University Center for Ambulatory Surgery. Participants must be interested in joining and able to give informed consent.

Inclusion Criteria

I have had surgery to realign my kneecap.

I am 18 years old or older.

I have had ACL reconstruction surgery.

Exclusion Criteria

Existing nerve injury

I am under 18 years old.

I am allergic to certain local anesthetics like bupivacaine or ropivacaine.

What Are the Treatments Tested in This Trial?

Interventions

• 1.3% liposomal bupivacaine (Exparel)
• Bupivacaine 0.5% Injectable Solution
• Ropivacaine 0.2% Injectable Solution

Trial Overview

The study compares two pain management methods after surgery: a postoperative infusion pump delivering local anesthetics directly to the surgical site versus a preoperative nerve block. The goal is to see which method better reduces pain scores and lessens the need for painkillers.

How Is the Trial Designed?

Group I: Post-Operative: Continuous ropivacaine via Ambit pump Experimental Treatment 3 Interventions

Postoperatively, infusion pump reservoirs will contain 0.20% ropivacaine and infused via the Ambit pump (8cc/hr for knees, 6cc/hr for shoulders).

Group II: Pre-Operative: Liposomal bupivacaine (Exparel) Active Control 2 Interventions

A single-shot of Liposomal Bupivicaine (Exparel) will be administered pre-operatively

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+