Post Operative Infusion Pump Pain Study

NCT07349810 | Recruiting Phase 4 FDA Drug

• 1 other identifier: Pro2022000405
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

  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. NPRS score difference of approximately 1.5 +/- 1 (approximately 2 points) to detect clinically significant difference in pain score.

  Postoperative days 0, 1,2,3,4,7,10, 14

Secondary Outcomes (2)

• Evaluate the requirement of narcotic and non-narcotic analgesic medications between the two groups

  Postoperative period through day 14

• Safety Outcomes

  Postoperative period through day 14

Study Arms (2)

Post-Operative: Continuous ropivacaine via Ambit pump

EXPERIMENTAL

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

Drug: Bupivacaine 0.5% Injectable Solution; Drug: Ropivacaine 0.2% Injectable Solution; Device: ambIT Infusion Pump

Pre-Operative: Liposomal bupivacaine (Exparel)

ACTIVE COMPARATOR

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

Drug: Bupivacaine 0.5% Injectable Solution; Drug: 1.3% liposomal bupivacaine (Exparel)

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

Post-Operative: Continuous ropivacaine via Ambit pump; Pre-Operative: Liposomal bupivacaine (Exparel)

Ropivacaine 0.2% Injectable Solution DRUG

Post-operative continuous infusion

Post-Operative: Continuous ropivacaine via Ambit pump

1.3% liposomal bupivacaine (Exparel) DRUG

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

Pre-Operative: Liposomal bupivacaine (Exparel)

ambIT Infusion Pump DEVICE

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

Post-Operative: Continuous ropivacaine via Ambit pump

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

University Center for Ambulatory Surgery

Somerset, New Jersey, 08873, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Charles Gatt, MD

CONTACT

732-537-0909; cjgatt85@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of the Department of Orthopaedic Surgery at Rutgers Robert Wood Johnson

Model Details: This study will be a pragmatic, prospective cluster randomized trial, where clusters will formed based on sequential 4 week time increments across the study recruitment period.

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 20, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.

Locations

US (1)