Quality of Analgesia After Interscalene Block After Arthroscopic Shoulder Surgery

NCT ID: NCT02554357

Last Updated: 2016-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-03-31

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.

Conditions

Injury of Shoulder Region

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Exparel block in arthroscopic surgery

Evaluation of Exparel block in arthroscopic shoulder surgery.

Group Type: EXPERIMENTAL

Exparel block in arthroscopic shoulder surgery

Intervention Type: DRUG

The interscalene block will be performed with ultrasound guidance and nerve stimulation.

Bupivacaine block in shoulder surgery

Evaluation of Bupivacaine block in shoulder surgery.

Group Type: EXPERIMENTAL

Bupivacaine block in shoulder surgery

Intervention Type: DRUG

The interscalene block will be performed with ultrasound guidance and nerve stimulation.

Interventions

Exparel block in arthroscopic shoulder surgery

The interscalene block will be performed with ultrasound guidance and nerve stimulation.

Intervention Type: DRUG

Bupivacaine block in shoulder surgery

The interscalene block will be performed with ultrasound guidance and nerve stimulation.

Intervention Type: DRUG

Other Intervention Names

ISBPB with bupivacaine and Exparel; ISBPB with bupivacaine alone

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York School of Regional Anesthesia

OTHER

Sponsor Role: collaborator

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: collaborator

North American Institute for Continuing Medical Education (NAICE)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Admir Hadzic, MD

Role: STUDY_DIRECTOR

Director

Locations

Department of Anesthesiology Ziekenhuis Oost-Limburg

Genk, , Belgium

Department of Anesthesiology ZOL

Genk, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 28157791 (View on PubMed)

Other Identifiers

NAICE-002

Identifier Type: -

Identifier Source: org_study_id