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Post Operative Infusion Pump Pain Study

NCT07349810 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-01-21

No results posted yet for this study

Summary

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.

Conditions

  • Post Operative Pain

Interventions

DRUG

Bupivacaine 0.5% Injectable Solution

Preoperatively, a nerve block consisting of 0.5% bupivacaine will be given to ALL patients * A bolus of 20cc will be used for saphenous nerve blocks for knee surgeries * A bolus of 15cc will be used for interscalene nerve blocks for shoulder surgeries

DRUG

Ropivacaine 0.2% Injectable Solution

Post-operative continuous infusion

DRUG

1.3% liposomal bupivacaine (Exparel)

Pre-operative infiltrative of 10cc of 1.3% liposomal bupivacaine (Exparel)

DEVICE

ambIT Infusion Pump

A pain pump provides intermittent delivery of medication to manage post-surgery pain.

Sponsors & Collaborators

  • Rutgers, The State University of New Jersey

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-06-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07349810 on ClinicalTrials.gov