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Quality of Analgesia After Interscalene Block After Arthroscopic Shoulder Surgery

N

North American Institute for Continuing Medical Education (NAICE)

Status

Completed

Conditions

Injury of Shoulder Region

Treatments

Drug: Exparel block in arthroscopic shoulder surgery
Drug: Bupivacaine block in shoulder surgery

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02554357
NAICE-002

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

Exparel block in arthroscopic surgery
Experimental group
Description:
Evaluation of Exparel block in arthroscopic shoulder surgery.
Treatment:
Drug: Exparel block in arthroscopic shoulder surgery
Bupivacaine block in shoulder surgery
Experimental group
Description:
Evaluation of Bupivacaine block in shoulder surgery.
Treatment:
Drug: Bupivacaine block in shoulder surgery

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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