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Completed

NCT Number: NCT03738696

Liposomal Bupivacaine in Rotator Cuff Repair

To assess the efficacy of interscalene liposomal bupivacaine in controlling postoperative pain scores, oral morphine equivalents and sleep quality after arthroscopic rotator cuff repair surgery as compared to interscalene catheter.

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Key information

Conditions

Rotator Cuff Injury Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UAB Hospital-Highlands

Birmingham, Alabama, 35205, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Undergoing outpatient arthroscopic rotator cuff repair
  • Greater than or equal to 19 years of age at the time of surgery

Exclusion criteria

  • Planned operative fixation of the biceps tendon or acromioclavicular joint
  • Opioid use 6 weeks before surgery
  • Gabapentin use 6 weeks before surgery
  • History of prior shoulder surgery on the operative limb
  • Severe pulmonary dysfunction
  • Diagnosis of chronic pain, fibromyalgia or other somatosensory disorder(s)
  • History of radicular pain or neuropathy in the operative limb
  • Patients who are currently incapacitated for medical decision making

Treatment and study plan

Exparel

Drug

A long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain

Other names: liposomal bupivacaine

Ropivacaine

Drug

A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain

Primary outcomes

  1. Average Postoperative Pain Scores Over a 96 Hour Timeframe

    Time frame: Up to 96 hrs postoperative

    Visual analog pain scores after operation [0-10, with 10 being the worst pain]

Secondary outcomes

  1. Average Postoperative Oral Morphine Equivalents Over a 96 Hour Timeframe

    Time frame: Up to 96 hrs

    oral morphine equivalents of all opioid-containing medications received

  2. Average Analgesia Satisfaction Over a 96 Hour Timeframe

    Time frame: Up to 96 hrs

    Likert scale of analgesia satisfaction [0-5, with 5 being the most satisfied]

  3. Percentage of Participants With Analgesia Complications

    Time frame: Up to 96 hrs

    Complications resulting from the method of analgesia utilized

  4. Average Sleep Quality Over a 96 Hour Timeframe

    Time frame: Up to 96 hrs postoperative

    Scale of sleep quality [0-10, with 10 being the most satisfied]

  5. Average Hours of Painless Sleep

    Time frame: Up to 96 hrs postoperative

    Hours of sleep uninterrupted by pain [numerical, hours]

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Pacira Pharmaceuticals, Inc

Registry information

Official study title

Efficacy of Liposomal Bupivacaine in Arthroscopic Rotator Cuff Repair

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 13, 2018
Registry last updated
May 16, 2024

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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