Liposomal Bupivacaine for Pain Control After Total Shoulder Arthroplasty

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Johns Hopkins University

Status

Completed

Conditions

Shoulder Pain
Osteoarthritis
Closed Fracture Proximal Humerus, Four Part
Arthropathy

Treatments

Drug: Interscalene Nerve Block
Drug: Liposomal bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02762071
IRB00063657

Details and patient eligibility

About

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.

Full description

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).

Enrollment

108 patients

Sex

All

Ages

20 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

108 participants in 2 patient groups

Interscalene Nerve Block
Active Comparator group
Description:
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.
Treatment:
Drug: Interscalene Nerve Block
Liposomal Bupivacaine
Experimental group
Description:
Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
Treatment:
Drug: Liposomal bupivacaine

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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