Quality of Analgesia After Interscalene Block After Arthroscopic Shoulder Surgery
Primary Purpose
Injury of Shoulder Region
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Exparel block in arthroscopic shoulder surgery
Bupivacaine block in shoulder surgery
Sponsored by
About this trial
This is an interventional treatment trial for Injury of Shoulder Region
Eligibility Criteria
Inclusion Criteria:
- Dutch or English speaking adults
- 18 years or older ASA I-III physical class
- Scheduled for elective arthroscopic shoulder surgery
Exclusion Criteria:
- History of allergy to a local anesthetic
- Baseline neurological deficit
- Medical condition that would make it difficult to assess sensory distribution or communicate with the investigators' staff
- Recent history (< 3 months) of drug or alcohol abuse
- Concomitant opioid therapy
- Preexisting coagulation disorder
- Infection at the injection site
- Pregnancy
Sites / Locations
- Department of Anesthesiology Ziekenhuis Oost-Limburg
- Department of Anesthesiology ZOL
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Exparel block in arthroscopic surgery
Bupivacaine block in shoulder surgery
Arm Description
Evaluation of Exparel block in arthroscopic shoulder surgery.
Evaluation of Bupivacaine block in shoulder surgery.
Outcomes
Primary Outcome Measures
Worst pain
Satisfaction with analgesia
Secondary Outcome Measures
Onset of sensory block
Duration of sensory block
Onset of motor block
duration of motor block
functionality of the surgical arm
Full Information
NCT ID
NCT02554357
First Posted
July 11, 2015
Last Updated
September 7, 2016
Sponsor
North American Institute for Continuing Medical Education (NAICE)
Collaborators
New York School of Regional Anesthesia, Pacira Pharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT02554357
Brief Title
Quality of Analgesia After Interscalene Block After Arthroscopic Shoulder Surgery
Official Title
Quality of Analgesia After Interscalene Block With Bupivacaine and Exparel® vs. Bupivacaine Alone After Arthroscopic Shoulder Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
North American Institute for Continuing Medical Education (NAICE)
Collaborators
New York School of Regional Anesthesia, Pacira Pharmaceuticals, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Shoulder arthroscopic causes post operative pain that outlasts analgesia provided by single injection nerve blocks.
Detailed Description
The interscalene brachial plexus block (ISBPB) is a common analgesic technique for procedures of the shoulder and upper arm.
Moreover, the incidence of rebound pain is well documented and is often of considerable discomfort to patients, who may quickly go from little or no pain to moderate-severe pain. Continuous nerve block techniques with home ambulatory catheters are currently utilized to manage postoperative pain.This study is designed to compare the level and duration of pain control of Exparel® injected after bupivacaine via stop-cock connected syringes and bupivacaine alone for ISBPB.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injury of Shoulder Region
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exparel block in arthroscopic surgery
Arm Type
Experimental
Arm Description
Evaluation of Exparel block in arthroscopic shoulder surgery.
Arm Title
Bupivacaine block in shoulder surgery
Arm Type
Experimental
Arm Description
Evaluation of Bupivacaine block in shoulder surgery.
Intervention Type
Drug
Intervention Name(s)
Exparel block in arthroscopic shoulder surgery
Other Intervention Name(s)
ISBPB with bupivacaine and Exparel
Intervention Description
The interscalene block will be performed with ultrasound guidance and nerve stimulation.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine block in shoulder surgery
Other Intervention Name(s)
ISBPB with bupivacaine alone
Intervention Description
The interscalene block will be performed with ultrasound guidance and nerve stimulation.
Primary Outcome Measure Information:
Title
Worst pain
Time Frame
assessed by the Modified Brief Pain Inventory short form Question 1 in the first postoperative week - postoperative day (POD) 1 through POD7
Title
Satisfaction with analgesia
Time Frame
assessed by the Overall Benefit of Analgesia Score (OBAS) in the first postoperative week postoperative day (POD)1 through POD7
Secondary Outcome Measure Information:
Title
Onset of sensory block
Time Frame
onset will be measured up to 30 minutes
Title
Duration of sensory block
Time Frame
duration will be measured up to 72 hours
Title
Onset of motor block
Time Frame
onset will be measured up to 30 minutes
Title
duration of motor block
Time Frame
duration will be measured up to 72 hours
Title
functionality of the surgical arm
Time Frame
assessed on the scale 0-5 in the first postoperative week - postoperative day (POD) 2- POD7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Dutch or English speaking adults
18 years or older ASA I-III physical class
Scheduled for elective arthroscopic shoulder surgery
Exclusion Criteria:
History of allergy to a local anesthetic
Baseline neurological deficit
Medical condition that would make it difficult to assess sensory distribution or communicate with the investigators' staff
Recent history (< 3 months) of drug or alcohol abuse
Concomitant opioid therapy
Preexisting coagulation disorder
Infection at the injection site
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Admir Hadzic, MD
Organizational Affiliation
Director
Official's Role
Study Director
Facility Information:
Facility Name
Department of Anesthesiology Ziekenhuis Oost-Limburg
City
Genk
Country
Belgium
Facility Name
Department of Anesthesiology ZOL
City
Genk
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
28157791
Citation
Vandepitte C, Kuroda M, Witvrouw R, Anne L, Bellemans J, Corten K, Vanelderen P, Mesotten D, Leunen I, Heylen M, Van Boxstael S, Golebiewski M, Van de Velde M, Knezevic NN, Hadzic A. Addition of Liposome Bupivacaine to Bupivacaine HCl Versus Bupivacaine HCl Alone for Interscalene Brachial Plexus Block in Patients Having Major Shoulder Surgery. Reg Anesth Pain Med. 2017 May/Jun;42(3):334-341. doi: 10.1097/AAP.0000000000000560.
Results Reference
derived
Learn more about this trial
Quality of Analgesia After Interscalene Block After Arthroscopic Shoulder Surgery
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