Recruiting

Pain Management

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT07349810

Conditions

Post Operative Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bupivacaine 0.5% Injectable Solution

Ropivacaine 0.2% Injectable Solution

1.3% liposomal bupivacaine (Exparel)

ambIT Infusion Pump

Study Details

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

Study ID

NCT07349810

Start date

Jan 1, 2026

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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

Ropivacaine 0.2% Injectable Solution

Post-operative continuous infusion

1.3% liposomal bupivacaine (Exparel)

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

ambIT Infusion Pump

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

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 and Locations

Central contacts

Locations

University Center for Ambulatory Surgery

Recruiting

Somerset, New Jersey, United States, 08873

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-01-21.