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Completed

NCT Number: NCT02554357

Quality of Analgesia After Interscalene Block After Arthroscopic Shoulder Surgery

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

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Key information

Conditions

Injury of Shoulder Region Shoulder Injuries Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology ZOL, Genk, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exparel block in arthroscopic shoulder surgery

Drug

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

Other names: ISBPB with bupivacaine and Exparel

Bupivacaine block in shoulder surgery

Drug

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

Other names: ISBPB with bupivacaine alone

Primary outcomes

  1. Worst pain

    Time frame: assessed by the Modified Brief Pain Inventory short form Question 1 in the first postoperative week - postoperative day (POD) 1 through POD7

  2. Satisfaction with analgesia

    Time frame: assessed by the Overall Benefit of Analgesia Score (OBAS) in the first postoperative week postoperative day (POD)1 through POD7

Secondary outcomes

  1. Onset of sensory block

    Time frame: onset will be measured up to 30 minutes

  2. Duration of sensory block

    Time frame: duration will be measured up to 72 hours

  3. Onset of motor block

    Time frame: onset will be measured up to 30 minutes

  4. duration of motor block

    Time frame: duration will be measured up to 72 hours

  5. functionality of the surgical arm

    Time frame: assessed on the scale 0-5 in the first postoperative week - postoperative day (POD) 2- POD7

Sponsors and collaborators

Lead sponsor

North American Institute for Continuing Medical Education (NAICE)

Other

Collaborators

  • New York School of Regional Anesthesia
  • Pacira Pharmaceuticals, Inc

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 18, 2015
Registry last updated
Sep 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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