Quality of Analgesia After Interscalene Block After Arthroscopic Shoulder Surgery

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

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

Study Overview

• Status: Completed
• Conditions: Injury of Shoulder Region
• Intervention / Treatment: Drug: Exparel block in arthroscopic shoulder surgery; Drug: Bupivacaine block in shoulder surgery

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Genk, Belgium
    • Department of Anesthesiology Ziekenhuis Oost-Limburg
  • Genk, Belgium
    • Department of Anesthesiology ZOL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exparel block in arthroscopic surgery; Evaluation of Exparel block in arthroscopic shoulder surgery.	Drug: Exparel block in arthroscopic shoulder surgery; The interscalene block will be performed with ultrasound guidance and nerve stimulation.; Other Names: ISBPB with bupivacaine and Exparel
Experimental: Bupivacaine block in shoulder surgery; Evaluation of Bupivacaine block in shoulder surgery.	Drug: Bupivacaine block in shoulder surgery; The interscalene block will be performed with ultrasound guidance and nerve stimulation.; Other Names: ISBPB with bupivacaine alone

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Onset of sensory block	onset will be measured up to 30 minutes
Duration of sensory block	duration will be measured up to 72 hours
Onset of motor block	onset will be measured up to 30 minutes
duration of motor block	duration will be measured up to 72 hours
functionality of the surgical arm	assessed on the scale 0-5 in the first postoperative week - postoperative day (POD) 2- POD7

Collaborators and Investigators

• Sponsor: North American Institute for Continuing Medical Education (NAICE)
• Collaborators: Pacira Pharmaceuticals, Inc; New York School of Regional Anesthesia
• Investigators: Study Director: Admir Hadzic, MD, Director

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: July 11, 2015
• First Submitted That Met QC Criteria: September 16, 2015
• First Posted (Estimate): September 18, 2015

Study Record Updates

• Last Update Posted (Estimate): September 8, 2016
• Last Update Submitted That Met QC Criteria: September 7, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: NAICE-002