Post Operative Infusion Pump Pain Study

Rutgers The State University of New Jersey

Status and phase: Enrolling; Phase 4

Conditions: Post Operative Pain

Treatments: Drug: 1.3% liposomal bupivacaine (Exparel); Device: ambIT Infusion Pump; Drug: Bupivacaine 0.5% Injectable Solution; Drug: Ropivacaine 0.2% Injectable Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT07349810

Pro2022000405

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years or older
• ACL reconstruction
• Open shoulder labrum or rotator cuff surgery
• Arthroscopic rotator cuff repair
• Proximal or distal patellar realignment surgery
• Open knee arthrotomy cases - Inside out meniscus repair, OCA, MAT

Exclusion criteria

• Age under 18 years
• Body mass index of greater than 40 kg/m2
• American Society of Anesthesiologist class 4 physical status or greater
• History of drug or alcohol abuse
• Chronic opioid use/pain management doctor
• Allergy to bupivacaine, ropivacaine or pharmacologic analogs
• Any coagulation disorders
• Existing nerve injury
• Severe bronchopulmonary disease
• Pregnant patients

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Post-Operative: Continuous ropivacaine via Ambit pump

Experimental group

Description:

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

Treatment:

Drug: Ropivacaine 0.2% Injectable Solution

Device: ambIT Infusion Pump

Drug: Bupivacaine 0.5% Injectable Solution

Pre-Operative: Liposomal bupivacaine (Exparel)

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine 0.5% Injectable Solution

Drug: 1.3% liposomal bupivacaine (Exparel)