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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. Identifier: NCT02182752
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : January 5, 2016
Aretaieion University Hospital
Information provided by (Responsible Party):
Eleftheria Soulioti, Asklepieion Voulas General Hospital

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.

Condition or disease Intervention/treatment Phase
Shoulder Fracture Shoulder Dislocation Rotator Cuff Injury Shoulder Arthritis Drug: Ropivacaine - Tramadol Drug: Ropivacaine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Tramadol on Interscalene Brachial Plexus Block With Ropivacaine in Shoulder Surgery.
Study Start Date : April 2013
Actual Primary Completion Date : January 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Ropivacaine - Tramadol Drug: Ropivacaine - Tramadol
Interscalene block using ropivacaine plus tramadol

Active Comparator: Ropivacaine Drug: Ropivacaine
Interscalene block using ropivacaine

Primary Outcome Measures :
  1. Postoperative analgesia [ Time Frame: 24 hours postoperatively ]

Secondary Outcome Measures :
  1. Persistent postoperative pain [ Time Frame: 1 month postoperatively, 3 months postoperatively ]
  2. Evidence of motor blockade resolution, confirmed by elbow - wrist - fingers active movement [ Time Frame: 24 hours postoperatively ]
  3. Evidence of sensory blockade resolution, confirmed by pin-prick test [ Time Frame: 24 hours postoperatively ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Shoulder surgery

Exclusion Criteria:

  • patients on opioids
  • diabetes mellitus
  • interscalene block contraindicated
  • patient refusing regional anesthesia techniques

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 identifier (NCT number): NCT02182752

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Asklepieion Hospital of Voula
Athens, Attica, Greece, 16673
Sponsors and Collaborators
Asklepieion Voulas General Hospital
Aretaieion University Hospital
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Responsible Party: Eleftheria Soulioti, MD, Asklepieion Voulas General Hospital Identifier: NCT02182752    
Other Study ID Numbers: 3694/27-3-13
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Shoulder Dislocation
Rotator Cuff Injuries
Shoulder Fractures
Joint Diseases
Musculoskeletal Diseases
Joint Dislocations
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Fractures, Bone
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid