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NCT Number: NCT05068960

Postoperative Pain Control in Total Shoulder Arthroplasty

A double blind, prospective, randomized trial to evaluate postoperative pain, narcotic use, patient satisfaction, and function among shoulder arthroplasty patients receiving interscalene block with and without the addition of liposomal bupivacaine.

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Key information

Conditions

Total Shoulder Arthroplasty

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Scripps Clinic

La Jolla, California, 92037, United States

About this study

In order to reduce narcotic abuse potential, orthopaedic surgeons have explored multimodal pain regimens in addition to regional anesthesia to improve postoperative pain control. One commonly used intervention to reduce postoperative shoulder pain has been the interscalene brachial plexus block. This block provides significant pain relief for shoulder procedures, but has been limited to less than 24 hours even with long acting anesthetics. In the setting of shoulder arthroplasty, this short-term pain control often leads to the need for increased narcotic pain medication. Since shoulder arthroplasty has been steadily increasing in the United States with an annual growth rate of 10.6%, it is imperative to control patients' postoperative pain without increasing their risk for opiate abuse. A potential method for achieving this is by using liposomal bupivacaine in the interscalene blocks.

This study is a double blind, prospective, randomized trial to evaluate the postoperative pain profiles among shoulder arthroplasty patients receiving interscalene block with and without the addition of liposomal bupivacaine. The purpose of this study is to determine if patients undergoing shoulder arthroplasty with an interscalene brachial plexus block with liposomal bupivacaine (study group) or without liposomal bupivacaine (control group) will have differences in postoperative opiate consumption, patient-reported pain, satisfaction with surgery, and shoulder function.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients undergoing primary shoulder arthroplasty or reverse shoulder arthroplasty

Exclusion criteria

  • Patients under the age of 50 years
  • Patients over the age of 85
  • Patients undergoing a revision shoulder procedure
  • Documented drug or alcohol abuse
  • Active narcotic use within 3 months prior to surgery
  • Neurological deficit
  • Allergy to amide anesthetics
  • Oxycodone intolerance
  • Unable to take Celebrex
  • Enrollment in another clinical trial
  • Comorbidity that is contraindicated with the administration of an interscalene block
  • Cognitive or mental health status that interferes with study

Treatment and study plan

Liposomal bupivacaine

Drug

Addition of liposomal bupivacaine to the interscalene block for extended pain control following total shoulder arthroplasty

Other names: Exparel

Bupivacaine

Drug

Interscalene block with bupivacaine for pain control following total shoulder arthroplasty

Other names: Marcaine

Primary outcomes

  1. Narcotic usage

    Time frame: Postoperatively (up to 1 week)

    Number and type of narcotic pain pills consumed during the first postoperative week (also converted into morphine equivalents)

Secondary outcomes

  1. Severity of pain and its impact on functioning (Brief Pain Inventory - Short Form modified)

    Time frame: Postoperatively (at 1 week)

    Patients' self-reported pain severity and impact on functioning as measured on the Brief Pain Inventory Short-Form modified survey

  2. Pain score (Numeric Rating Scale): Preoperatively, postoperatively, and change from preoperatively to postoperatively

    Time frame: Preoperatively (up to 30 days before surgery) and postoperatively (at 4 weeks), and change from preoperatively to postoperatively

    Patients' self-reported pain as measured on the Numeric Rating Scale

  3. American Shoulder and Elbow Surgeons (ASES) score: preoperatively, postoperatively, and change from preoperatively to postoperatively

    Time frame: Preoperatively (up to 30 days before surgery) and postoperatively (at 4 weeks), and change from preoperatively to postoperatively

    The ASES score is a 100-point scale that evaluates two dimensions of shoulder function: pain and performance in activities of daily living. Each of the two domains make up for 50 of the 100 points. A score of 0 indicates the worst shoulder condition and a score of 100 indicates the best shoulder condition.

  4. Satisfaction with the results of surgery (Self-Administered Patient Satisfaction Scale)

    Time frame: Postoperatively (at 4 weeks)

    Patients' satisfaction with results of surgery as measured on the Self-Administered Patient Satisfaction Scale

  5. Non narcotic pain medication usage

    Time frame: Postoperatively (up to 1 week)

    Number and type of non-narcotic pain pills consumed during the first postoperative week

Sponsors and collaborators

Lead sponsor

Scripps Clinic

Other

Registry information

Official study title

A Prospective Randomized Controlled Trial to Evaluate the Efficacy of an Interscalene Brachial Plexus Block and Multimodal Analgesia With and Without Liposomal Bupivacaine for Postoperative Pain Control in Total Shoulder Arthroplasty

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Oct 6, 2021
Registry last updated
Mar 21, 2025

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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