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Liposomal Bupivacaine for Pain Control After Total Shoulder Arthroplasty

Primary Purpose

Osteoarthritis, Arthropathy, Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Liposomal bupivacaine
Interscalene Nerve Block
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Johns Hopkins University
  • University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Interscalene Nerve Block

Liposomal Bupivacaine

Arm 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.

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

Outcomes

Primary Outcome Measures

Visual Analog Scale Pain Score at 24 Hours Postoperatively
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 Outcome Measures

Opioid Medication Consumption in Morphine Milligram Equivalents
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.
Length of Hospital Stay
Duration of stay in hospital (hours) after shoulder replacement surgery.
Postoperative Visual Analog Scale (VAS) Pain Scores
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).
Patient Satisfaction With Pain Management
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).
Length of Stay in the Post-anesthesia Care Unit (PACU)
Duration of stay in the post-anesthesia care unit (minutes) after shoulder replacement surgery.

Full Information

First Posted
April 28, 2016
Last Updated
March 17, 2020
Sponsor
Johns Hopkins University
Collaborators
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02762071
Brief Title
Liposomal Bupivacaine for Pain Control After Total Shoulder Arthroplasty
Official Title
Liposomal Bupivacaine vs. Interscalene Nerve Block for Pain Control After Total Shoulder Arthroplasty: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
April 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Arthropathy, Shoulder Pain, Closed Fracture Proximal Humerus, Four Part

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interscalene Nerve Block
Arm Type
Active Comparator
Arm 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.
Arm Title
Liposomal Bupivacaine
Arm Type
Experimental
Arm Description
Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Other Intervention Name(s)
Exparel
Intervention Description
Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
Intervention Type
Drug
Intervention Name(s)
Interscalene Nerve Block
Intervention 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.
Primary Outcome Measure Information:
Title
Visual Analog Scale Pain Score at 24 Hours Postoperatively
Description
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).
Time Frame
At 24 hours after surgery
Secondary Outcome Measure Information:
Title
Opioid Medication Consumption in Morphine Milligram Equivalents
Description
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.
Time Frame
Up to 4 days postoperatively
Title
Length of Hospital Stay
Description
Duration of stay in hospital (hours) after shoulder replacement surgery.
Time Frame
At the time of discharge from hospital, Up to 4 days
Title
Postoperative Visual Analog Scale (VAS) Pain Scores
Description
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).
Time Frame
Up to first postoperative visit, maximum 30 days
Title
Patient Satisfaction With Pain Management
Description
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).
Time Frame
At first postoperative visit, up to 30 days
Title
Length of Stay in the Post-anesthesia Care Unit (PACU)
Description
Duration of stay in the post-anesthesia care unit (minutes) after shoulder replacement surgery.
Time Frame
At the time of discharge from PACU, Up to 1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uma Srikumaran, MD, MBA
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Liposomal Bupivacaine for Pain Control After Total Shoulder Arthroplasty

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