Post Operative Infusion Pump Pain Study

Continuous Infusion Pump Versus Single Shot Peripheral Block for Pain Management After Same-day Orthopaedic Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Post Operative Pain
• Intervention / Treatment: Drug: Bupivacaine 0.5% Injectable Solution; Drug: Ropivacaine 0.2% Injectable Solution; Drug: 1.3% liposomal bupivacaine (Exparel); Device: ambIT Infusion Pump

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Charles Gatt, MD; Phone Number: 732-537-0909; Email: cjgatt85@gmail.com

Study Locations

• United States
  • New Jersey
    • Somerset, New Jersey, United States, 08873
      • Recruiting
      • University Center for Ambulatory Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	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; Device: ambIT Infusion Pump; A pain pump provides intermittent delivery of medication to manage post-surgery pain.
Active Comparator: Pre-Operative: Liposomal bupivacaine (Exparel); A single-shot of Liposomal Bupivicaine (Exparel) will be administered pre-operatively	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: 1.3% liposomal bupivacaine (Exparel); Pre-operative infiltrative of 10cc of 1.3% liposomal bupivacaine (Exparel)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the requirement of narcotic and non-narcotic analgesic medications between the two groups	use of narcotic and other analgesic pain medication throughout the 14 day postoperative period	Postoperative period through day 14
Safety Outcomes	Evaluate the rates of catheter site infection, extravasation, pump malfunction	Postoperative period through day 14

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Ropivacaine; Bupivacaine
• Other Study ID Numbers: Pro2022000405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trail, after deidentification.
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No