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Quality of Analgesia After Interscalene Block After Arthroscopic Shoulder Surgery

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ClinicalTrials.gov Identifier: NCT02554357
Recruitment Status : Completed
First Posted : September 18, 2015
Last Update Posted : September 8, 2016
Sponsor:
Collaborators:
New York School of Regional Anesthesia
Pacira Pharmaceuticals, Inc
Information provided by (Responsible Party):
North American Institute for Continuing Medical Education (NAICE)

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

Condition or disease Intervention/treatment Phase
Injury of Shoulder Region Drug: Exparel block in arthroscopic shoulder surgery Drug: Bupivacaine block in shoulder surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Quality of Analgesia After Interscalene Block With Bupivacaine and Exparel® vs. Bupivacaine Alone After Arthroscopic Shoulder Surgery
Study Start Date : July 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: ISBPB with bupivacaine alone




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02554357


Locations
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Belgium
Department of Anesthesiology Ziekenhuis Oost-Limburg
Genk, Belgium
Department of Anesthesiology ZOL
Genk, Belgium
Sponsors and Collaborators
North American Institute for Continuing Medical Education (NAICE)
New York School of Regional Anesthesia
Pacira Pharmaceuticals, Inc
Investigators
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Study Director: Admir Hadzic, MD Director
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: North American Institute for Continuing Medical Education (NAICE)
ClinicalTrials.gov Identifier: NCT02554357    
Other Study ID Numbers: NAICE-002
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Shoulder Injuries
Wounds and Injuries
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents