Clinical trial NCT02554357: 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
Overall status: COMPLETED
Phase: NA
Conditions: Injury of Shoulder Region
Lead sponsor: North American Institute for Continuing Medical Education (NAICE)
Sponsor class: OTHER
Collaborators: name: New York School of Regional Anesthesia
name: Pacira Pharmaceuticals, Inc
First posted: 2015-09-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Worst pain
timeFrame: assessed by the Modified Brief Pain Inventory short form Question 1 in the first postoperative week - postoperative day (POD) 1 through POD7
measure: Satisfaction with analgesia
timeFrame: assessed by the Overall Benefit of Analgesia Score (OBAS) in the first postoperative week postoperative day (POD)1 through POD7
Secondary outcomes:
measure: Onset of sensory block
timeFrame: onset will be measured up to 30 minutes
measure: Duration of sensory block
timeFrame: duration will be measured up to 72 hours
measure: Onset of motor block
timeFrame: onset will be measured up to 30 minutes
measure: duration of motor block
timeFrame: duration will be measured up to 72 hours
measure: functionality of the surgical arm
timeFrame: assessed on the scale 0-5 in the first postoperative week - postoperative day (POD) 2- POD7
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Department of Anesthesiology Ziekenhuis Oost-Limburg
city: Genk
country: Belgium
facility: Department of Anesthesiology ZOL
Study officials:
affiliation: Director
name: Admir Hadzic, MD
role: STUDY_DIRECTOR
References:
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.