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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)

Tracking Information
First Submitted Date  ICMJE July 11, 2015
First Posted Date  ICMJE September 18, 2015
Last Update Posted Date September 8, 2016
Study Start Date  ICMJE July 2015
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2016)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 16, 2015)
Total opioid consumption for 72 hours post surgery [ Time Frame: opioid consuption will be recorded for 72h post in hours ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2016)
  • Onset of sensory block [ Time Frame: onset will be measured up to 30 minutes ]
  • Duration of sensory block [ Time Frame: duration will be measured up to 72 hours ]
  • Onset of motor block [ Time Frame: onset will be measured up to 30 minutes ]
  • duration of motor block [ Time Frame: duration will be measured up to 72 hours ]
  • functionality of the surgical arm [ Time Frame: assessed on the scale 0-5 in the first postoperative week - postoperative day (POD) 2- POD7 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2015)
  • Onset of sensory block [ Time Frame: onset will be mesured up to 30 minutes ]
  • Duration of sensory block [ Time Frame: duration will be mesured up to 72 hours ]
  • Onset of motor block [ Time Frame: onset will be mesured up to 30 minutes ]
  • duration of motor block [ Time Frame: duration will be mesured up to 72 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Quality of Analgesia After Interscalene Block After Arthroscopic Shoulder Surgery
Official Title  ICMJE Quality of Analgesia After Interscalene Block With Bupivacaine and Exparel® vs. Bupivacaine Alone After Arthroscopic Shoulder Surgery
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Injury of Shoulder Region
Intervention  ICMJE
  • 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
  • Drug: Bupivacaine block in shoulder surgery
    The interscalene block will be performed with ultrasound guidance and nerve stimulation.
    Other Name: ISBPB with bupivacaine alone
Study Arms  ICMJE
  • Experimental: Exparel block in arthroscopic surgery
    Evaluation of Exparel block in arthroscopic shoulder surgery.
    Intervention: Drug: Exparel block in arthroscopic shoulder surgery
  • Experimental: Bupivacaine block in shoulder surgery
    Evaluation of Bupivacaine block in shoulder surgery.
    Intervention: Drug: Bupivacaine block in shoulder surgery
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 7, 2016)
50
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2015)
40
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02554357
Other Study ID Numbers  ICMJE NAICE-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party North American Institute for Continuing Medical Education (NAICE)
Study Sponsor  ICMJE North American Institute for Continuing Medical Education (NAICE)
Collaborators  ICMJE
  • New York School of Regional Anesthesia
  • Pacira Pharmaceuticals, Inc
Investigators  ICMJE
Study Director: Admir Hadzic, MD Director
PRS Account North American Institute for Continuing Medical Education (NAICE)
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP