Back to resultsExparel for Postoperative Pain Management in Shoulder Surgery
Primary Purpose
Fracture of Shoulder and Upper Arm
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
1.3% Liposomal Bupivacaine
0.125% Bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Fracture of Shoulder and Upper Arm
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing shoulder arthroplasty under general anesthesia
- Patients undergoing open reduction internal fixation (ORIF) of a proximal humerus fracture under general anesthesia
- Patients with American Society of Anesthesiologist (ASA) physical status classification of 1-3
- Patients meeting criteria for standard of care continuous peripheral nerve block (CPNB) per anesthesia guidelines.
- Patients agreeing to be available for brief follow up telephone survey post- operatively and being mentally able to respond.
- Patients available for follow up routine post-operative clinic visits, per standard of care.
Exclusion Criteria:
- Contraindications to regional anesthesia
- Significant peripheral neuropathy or neurological disorder affecting the upper extremity
- Contraindication to a component of multimodal analgesia
- Pregnancy
- Opioid tolerance
- Cognitive or psychiatric condition that might affect patient assessment and/or inability to provide informed consent.
Sites / Locations
- Wayne State University Physician Group
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Liposomal Bupivacaine A
CISB control for A
Liposomal Bupivacaine B
CISB control for B
Arm Description
One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty
Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty .
One time injection of 1.3% Liposomal Bupivacaine during Humerus Fracture Fixation
Peripheral nerve block (CISB) with 0.125% bupivacaine during fracture fixation
Outcomes
Primary Outcome Measures
Quality of Analgesia
Quality of analgesia as measured by numerical rating scores for pain (active and at rest) as (0=no pain, 10= worst pain) every two hours for the initial 36 hours, then on day2, day7 and day30 postoperatively
Secondary Outcome Measures
Post Operative American Shoulder and Elbow Surgeons (ASES)
American Shoulder and Elbow Surgeons (ASES) score is an outcome reporting measure for assessments of shoulder function in patients with shoulder pathology and after shoulder arthroplasty surgery. ASES is a 100 points scale consisting of two measures: one pain scale (worth 50 points) and 10 activities of daily living(worth 50 points), the total score is the sum of both and the higher total score indicates better outcome.
Subjective Shoulder Value (SSV)
Functional assessments after shoulder arthroplasty surgery. The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. The range is between 0% and 100%
Incidence of Nerve Injury
Neuropraxia on the treatment side
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02472314
Brief Title
Exparel for Postoperative Pain Management in Shoulder Surgery
Official Title
A Novel Application of Exparel for Postoperative Pain Management in Shoulder Arthroplasty and Humerus Fracture Fixation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the effect of liposomal Bupivacaine infiltration into the shoulder to continues nerve block with Bupivacaine on postoperative pain control and functional outcomes.
Detailed Description
liposomal bupivacaine analgesia will provide improved postoperative pain control, reduction in amount of opioid supplementation, decreased complications and faster return to function compared to current standard of care pain management for patients undergoing shoulder arthroplasty and shoulder surgery for proximal humerus fractures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture of Shoulder and Upper Arm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liposomal Bupivacaine A
Arm Type
Experimental
Arm Description
One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty
Arm Title
CISB control for A
Arm Type
Active Comparator
Arm Description
Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty .
Arm Title
Liposomal Bupivacaine B
Arm Type
Experimental
Arm Description
One time injection of 1.3% Liposomal Bupivacaine during Humerus Fracture Fixation
Arm Title
CISB control for B
Arm Type
Active Comparator
Arm Description
Peripheral nerve block (CISB) with 0.125% bupivacaine during fracture fixation
Intervention Type
Drug
Intervention Name(s)
1.3% Liposomal Bupivacaine
Other Intervention Name(s)
Exparel
Intervention Description
local tissue infiltration of Liposomal Bupivacaine during surgery
Intervention Type
Drug
Intervention Name(s)
0.125% Bupivacaine
Other Intervention Name(s)
Bupivacaine
Intervention Description
Continues nerve block with Bupivacaine during surgery and postoperatively
Primary Outcome Measure Information:
Title
Quality of Analgesia
Description
Quality of analgesia as measured by numerical rating scores for pain (active and at rest) as (0=no pain, 10= worst pain) every two hours for the initial 36 hours, then on day2, day7 and day30 postoperatively
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Post Operative American Shoulder and Elbow Surgeons (ASES)
Description
American Shoulder and Elbow Surgeons (ASES) score is an outcome reporting measure for assessments of shoulder function in patients with shoulder pathology and after shoulder arthroplasty surgery. ASES is a 100 points scale consisting of two measures: one pain scale (worth 50 points) and 10 activities of daily living(worth 50 points), the total score is the sum of both and the higher total score indicates better outcome.
Time Frame
Preoperative, 6 weeks and last follow up
Title
Subjective Shoulder Value (SSV)
Description
Functional assessments after shoulder arthroplasty surgery. The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. The range is between 0% and 100%
Time Frame
Pre-operative, 6 weeks and last Follow up
Title
Incidence of Nerve Injury
Description
Neuropraxia on the treatment side
Time Frame
During hospital stay and at 2 weeks and 6 weeks post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing shoulder arthroplasty under general anesthesia
Patients undergoing open reduction internal fixation (ORIF) of a proximal humerus fracture under general anesthesia
Patients with American Society of Anesthesiologist (ASA) physical status classification of 1-3
Patients meeting criteria for standard of care continuous peripheral nerve block (CPNB) per anesthesia guidelines.
Patients agreeing to be available for brief follow up telephone survey post- operatively and being mentally able to respond.
Patients available for follow up routine post-operative clinic visits, per standard of care.
Exclusion Criteria:
Contraindications to regional anesthesia
Significant peripheral neuropathy or neurological disorder affecting the upper extremity
Contraindication to a component of multimodal analgesia
Pregnancy
Opioid tolerance
Cognitive or psychiatric condition that might affect patient assessment and/or inability to provide informed consent.
Facility Information:
Facility Name
Wayne State University Physician Group
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Exparel for Postoperative Pain Management in Shoulder Surgery
We'll reach out to this number within 24 hrs