Injury of Shoulder Region
Conditions
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.
Interventions
DRUGExparel block in arthroscopic shoulder surgery
The interscalene block will be performed with ultrasound guidance and nerve stimulation.
DRUGBupivacaine block in shoulder surgery
The interscalene block will be performed with ultrasound guidance and nerve stimulation.
Sponsors
New York School of Regional Anesthesia
Pacira Pharmaceuticals, Inc
North American Institute for Continuing Medical Education (NAICE)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Worst pain | assessed by the Modified Brief Pain Inventory short form Question 1 in the first postoperative week - postoperative day (POD) 1 through POD7 |
| Satisfaction with analgesia | assessed by the Overall Benefit of Analgesia Score (OBAS) in the first postoperative week postoperative day (POD)1 through POD7 |
Secondary
| Measure | Time frame |
|---|---|
| Onset of motor block | onset will be measured up to 30 minutes |
| Onset of sensory block | onset will be measured up to 30 minutes |
| functionality of the surgical arm | assessed on the scale 0-5 in the first postoperative week - postoperative day (POD) 2- POD7 |
| duration of motor block | duration will be measured up to 72 hours |
| Duration of sensory block | duration will be measured up to 72 hours |
Countries
Belgium
Outcome results
None listed