Quality of Analgesia After Interscalene Block After Arthroscopic Shoulder Surgery

Injury of Shoulder Region Clinical Trial

Official title:

Quality of Analgesia After Interscalene Block With Bupivacaine and Exparel® vs. Bupivacaine Alone After Arthroscopic Shoulder Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02554357
• Other study ID #: NAICE-002
• Status: Completed
• Phase: N/A
• First received: July 11, 2015
• Last updated: September 7, 2016
• Start date: July 2015
• Est. completion date: March 2016

Study information

• Verified date: September 2016
• Source: North American Institute for Continuing Medical Education (NAICE)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Shoulder arthroscopic causes post operative pain that outlasts analgesia provided by single injection nerve blocks.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Injury of Shoulder Region

Intervention

Drug:
• Exparel block in arthroscopic shoulder surgery
The interscalene block will be performed with ultrasound guidance and nerve stimulation.
• Bupivacaine block in shoulder surgery
The interscalene block will be performed with ultrasound guidance and nerve stimulation.

Locations

Country	Name	City	State
Belgium	Department of Anesthesiology Ziekenhuis Oost-Limburg	Genk
Belgium	Department of Anesthesiology ZOL	Genk

Sponsors (3)

Lead Sponsor	Collaborator
North American Institute for Continuing Medical Education (NAICE)	New York School of Regional Anesthesia - NYSORA, Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Worst pain		assessed by the Modified Brief Pain Inventory short form Question 1 in the first postoperative week - postoperative day (POD) 1 through POD7	No
Primary	Satisfaction with analgesia		assessed by the Overall Benefit of Analgesia Score (OBAS) in the first postoperative week postoperative day (POD)1 through POD7	No
Secondary	Onset of sensory block		onset will be measured up to 30 minutes	No
Secondary	Duration of sensory block		duration will be measured up to 72 hours	No
Secondary	Onset of motor block		onset will be measured up to 30 minutes	No
Secondary	duration of motor block		duration will be measured up to 72 hours	No
Secondary	functionality of the surgical arm		assessed on the scale 0-5 in the first postoperative week - postoperative day (POD) 2- POD7	No