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The Effect of Tramadol on Interscalene Brachial Plexus Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02182752
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : January 5, 2016
Sponsor:
Collaborator:
Aretaieion University Hospital
Information provided by (Responsible Party):
Eleftheria Soulioti, Asklepieion Voulas General Hospital

Tracking Information
First Submitted Date  ICMJE June 30, 2014
First Posted Date  ICMJE July 8, 2014
Last Update Posted Date January 5, 2016
Study Start Date  ICMJE April 2013
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2014)
Postoperative analgesia [ Time Frame: 24 hours postoperatively ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2014)
  • Persistent postoperative pain [ Time Frame: 1 month postoperatively, 3 months postoperatively ]
  • Evidence of motor blockade resolution, confirmed by elbow - wrist - fingers active movement [ Time Frame: 24 hours postoperatively ]
  • Evidence of sensory blockade resolution, confirmed by pin-prick test [ Time Frame: 24 hours postoperatively ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Tramadol on Interscalene Brachial Plexus Block
Official Title  ICMJE The Effect of Tramadol on Interscalene Brachial Plexus Block With Ropivacaine in Shoulder Surgery.
Brief Summary The purpose of our study is to evaluate the effect of tramadol as an adjunct to ropivacaine local anesthetic solution in interscalene brachial plexus block for shoulder surgery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Shoulder Fracture
  • Shoulder Dislocation
  • Rotator Cuff Injury
  • Shoulder Arthritis
Intervention  ICMJE
  • Drug: Ropivacaine - Tramadol
    Interscalene block using ropivacaine plus tramadol
  • Drug: Ropivacaine
    Interscalene block using ropivacaine
Study Arms  ICMJE
  • Active Comparator: Ropivacaine - Tramadol
    Intervention: Drug: Ropivacaine - Tramadol
  • Active Comparator: Ropivacaine
    Intervention: Drug: Ropivacaine
Publications *

*   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: January 2, 2016)
80
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2014)
70
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Shoulder surgery

Exclusion Criteria:

  • patients on opioids
  • diabetes mellitus
  • interscalene block contraindicated
  • patient refusing regional anesthesia techniques
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 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 Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02182752
Other Study ID Numbers  ICMJE 3694/27-3-13
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eleftheria Soulioti, Asklepieion Voulas General Hospital
Study Sponsor  ICMJE Asklepieion Voulas General Hospital
Collaborators  ICMJE Aretaieion University Hospital
Investigators  ICMJE Not Provided
PRS Account Asklepieion Voulas General Hospital
Verification Date January 2016

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