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NCT Number: NCT07349810

Post Operative Infusion Pump Pain Study

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Center for Ambulatory Surgery

Somerset, New Jersey, 08873, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

    Time frame: Postoperative days 0, 1,2,3,4,7,10, 14

    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.

Secondary outcomes

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

    Time frame: Postoperative period through day 14

    use of narcotic and other analgesic pain medication throughout the 14 day postoperative period

  2. Safety Outcomes

    Time frame: Postoperative period through day 14

    Evaluate the rates of catheter site infection, extravasation, pump malfunction

Study contacts

Contact information is provided by the study sponsor or research team.

Charles Gatt, MD

CONTACT

[email protected]

732-537-0909

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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