Post Operative Infusion Pump Pain Study

Part of paid clinical trials in Somerset, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT07349810
Phase
PHASE4
Status
Recruiting
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Conditions

  • Post Operative Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bupivacaine 0.5% Injectable Solution — DRUG
    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
  • Ropivacaine 0.2% Injectable Solution — DRUG
    Post-operative continuous infusion
  • 1.3% liposomal bupivacaine (Exparel) — DRUG
    Pre-operative infiltrative of 10cc of 1.3% liposomal bupivacaine (Exparel)
  • ambIT Infusion Pump — DEVICE
    A pain pump provides intermittent delivery of medication to manage post-surgery pain.

Study Details

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.

Key Dates

Start date
Jan 1, 2026
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Post-Operative: Continuous ropivacaine via Ambit pump
    Postoperatively, infusion pump reservoirs will contain 0.20% ropivacaine and infused via the Ambit pump (8cc/hr for knees, 6cc/hr for shoulders).
  • Active Comparator: Pre-Operative: Liposomal bupivacaine (Exparel)
    A single-shot of Liposomal Bupivicaine (Exparel) will be administered pre-operatively

Primary Outcome Measure

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 [ Time Frame: Postoperative days 0, 1,2,3,4,7,10, 14 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Center for Ambulatory SurgerySomersetNew Jersey08873-

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By research site
University Center for Ambulatory Surgery· Somerset, NJ

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