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The Effect of Tramadol on Interscalene Brachial Plexus Block

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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

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

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 ]


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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02182752


Locations
Greece
Asklepieion Hospital of Voula
Athens, Attica, Greece, 16673
Sponsors and Collaborators
Asklepieion Voulas General Hospital
Aretaieion University Hospital

Publications:
Responsible Party: Eleftheria Soulioti, MD, Asklepieion Voulas General Hospital
ClinicalTrials.gov Identifier: NCT02182752     History of Changes
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:
Shoulder Dislocation
Rotator Cuff Injuries
Shoulder Fractures
Joint Dislocations
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries
Shoulder Injuries
Rupture
Tendon Injuries
Fractures, Bone
Ropivacaine
Tramadol
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics