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NCT Number: NCT02762071

Liposomal Bupivacaine for Pain Control After Total Shoulder Arthroplasty

This study will compare interscalene nerve block versus liposomal bupivacaine (Exparel) for pain control after total shoulder replacements. Each method will be assessed in terms of post operative pain scores, pain medication consumption, length of stay, complications (nerve injuries, hematomas, cardiac/respiratory events) and rate of readmission due to pain. The aims of this study will be achieved through a randomized controlled trial and cost-effectiveness analysis.

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Key information

Conditions

Osteoarthritis Arthralgia Arthritis Arthropathy Closed Fracture Proximal Humerus, Four Part Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Shoulder Pain Signs and Symptoms

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University, Columbia, Maryland, United States

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About this study

After the decision to proceed with shoulder replacement surgery, patients will be asked to participate in this randomized trial. Consent will be completed after explanation of each treatment group and the data to be collected. Patients will be randomized into one of the two treatment groups by simple randomization into one of two groups: Group 1 will receive interscalene nerve block and group 2 will receive liposomal bupivacaine for postoperative analgesia. Randomization will be stratified by site.

The surgeon at each site will be trained prior to enrollment on the correct way to perform Exparel injections intraoperatively. Patients in the interscalene nerve block group will be given a single shot block in the preoperative area by a fellowship-trained anesthesiologist.

The primary outcome is pain score on a visual analog scale (VAS) at 24 hours postoperatively. VAS pain scores range from 0 (no pain) to 10 (unbearable pain). Secondary outcomes are postoperative VAS pain scores at 6, 12, 18, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 hours; VAS pain score at the first postoperative visit ; intraoperative opioid consumption; postoperative opioid consumption at days 1, 2, 3, and 4; total opioid consumption at day 1 (intraoperative + postoperative day 1); duration of stay in the post-anesthesia care unit (PACU); duration of hospital stay; and VAS score for satisfaction with pain control in the hospital and at home, assessed at participants' first postoperative visit. VAS satisfaction scores range from 0 (not satisfied) to 10 (completely satisfied).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Degenerative changes of the shoulder joint (documented by radiographs) in patients planning total joint replacement with one of the study's four fellowship-trained orthopaedic surgeons.
  • Patients who require revision surgeries, hemiarthroplasties, or who have chronic pain issues will be included.

Exclusion criteria

  • Allergy to liposomal bupivacaine
  • Contraindications to the interscalene nerve block such as:
  • Preexisting neurologic defects
  • Local anesthetic allergy
  • Coagulopathy
  • Contralateral phrenic nerve dysfunction
  • Severe chronic obstructive pulmonary disease

Treatment and study plan

Liposomal bupivacaine

Drug

Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.

Other names: Exparel

interscalene nerve block

Drug

Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.

Primary outcomes

  1. Visual Analog Scale Pain Score at 24 Hours Postoperatively

    Time frame: At 24 hours after surgery

    The primary outcome was pain score on a visual analog scale (VAS) at 24 hours postoperatively. VAS pain scores range from 0 (no pain) to 10 (unbearable pain).

Secondary outcomes

  1. Opioid Medication Consumption in Morphine Milligram Equivalents

    Time frame: Up to 4 days postoperatively

    We analyzed intraoperative opioid consumption; postoperative opioid consumption at days 1, 2, 3, and 4; total opioid consumption at day 1 (intraoperative + postoperative day 1). This was measured in morphine milligram equivalents.

  2. Length of Hospital Stay

    Time frame: At the time of discharge from hospital, Up to 4 days

    Duration of stay in hospital (hours) after shoulder replacement surgery.

  3. Postoperative Visual Analog Scale (VAS) Pain Scores

    Time frame: Up to first postoperative visit, maximum 30 days

    We analyzed postoperative VAS pain scores at 6, 12, 18, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 hours and at the first postoperative visit. VAS pain scores range from 0 (no pain) to 10 (unbearable pain).

  4. Patient Satisfaction With Pain Management

    Time frame: At first postoperative visit, up to 30 days

    Visual Analog Scale (VAS) score for satisfaction with pain control in the hospital and at home. This was assessed at subjects' first postoperative visit.VAS satisfaction scores range from 0 (not satisfied) to 10 (completely satisfied).

  5. Length of Stay in the Post-anesthesia Care Unit (PACU)

    Time frame: At the time of discharge from PACU, Up to 1 day

    Duration of stay in the post-anesthesia care unit (minutes) after shoulder replacement surgery.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • University of Texas Southwestern Medical Center

Registry information

Official study title

Liposomal Bupivacaine vs. Interscalene Nerve Block for Pain Control After Total Shoulder Arthroplasty: A Randomized Clinical Trial

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 4, 2016
Registry last updated
Mar 30, 2020

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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