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The Effect of Tramadol on Interscalene Brachial Plexus Block

Primary Purpose

Shoulder Fracture, Shoulder Dislocation, Rotator Cuff Injury

Status
Completed
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Ropivacaine - Tramadol
Ropivacaine
Sponsored by
Asklepieion Voulas General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Fracture

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Shoulder surgery

Exclusion Criteria:

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

Sites / Locations

  • Asklepieion Hospital of Voula

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ropivacaine - Tramadol

Ropivacaine

Arm Description

Outcomes

Primary Outcome Measures

Postoperative analgesia

Secondary Outcome Measures

Persistent postoperative pain
Evidence of motor blockade resolution, confirmed by elbow - wrist - fingers active movement
Evidence of sensory blockade resolution, confirmed by pin-prick test

Full Information

First Posted
June 30, 2014
Last Updated
January 2, 2016
Sponsor
Asklepieion Voulas General Hospital
Collaborators
Aretaieion University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02182752
Brief Title
The Effect of Tramadol on Interscalene Brachial Plexus Block
Official Title
The Effect of Tramadol on Interscalene Brachial Plexus Block With Ropivacaine in Shoulder Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asklepieion Voulas General Hospital
Collaborators
Aretaieion University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Fracture, Shoulder Dislocation, Rotator Cuff Injury, Shoulder Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine - Tramadol
Arm Type
Active Comparator
Arm Title
Ropivacaine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ropivacaine - Tramadol
Intervention Description
Interscalene block using ropivacaine plus tramadol
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Interscalene block using ropivacaine
Primary Outcome Measure Information:
Title
Postoperative analgesia
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Persistent postoperative pain
Time Frame
1 month postoperatively, 3 months postoperatively
Title
Evidence of motor blockade resolution, confirmed by elbow - wrist - fingers active movement
Time Frame
24 hours postoperatively
Title
Evidence of sensory blockade resolution, confirmed by pin-prick test
Time Frame
24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Shoulder surgery Exclusion Criteria: patients on opioids diabetes mellitus interscalene block contraindicated patient refusing regional anesthesia techniques
Facility Information:
Facility Name
Asklepieion Hospital of Voula
City
Athens
State/Province
Attica
ZIP/Postal Code
16673
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
23820103
Citation
Lin E, Choi J, Hadzic A. Peripheral nerve blocks for outpatient surgery: evidence-based indications. Curr Opin Anaesthesiol. 2013 Aug;26(4):467-74. doi: 10.1097/ACO.0b013e328362baa4.
Results Reference
background
PubMed Identifier
16979050
Citation
Bishop JY, Sprague M, Gelber J, Krol M, Rosenblatt MA, Gladstone JN, Flatow EL. Interscalene regional anesthesia for arthroscopic shoulder surgery: a safe and effective technique. J Shoulder Elbow Surg. 2006 Sep-Oct;15(5):567-70. doi: 10.1016/j.jse.2006.01.009.
Results Reference
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Learn more about this trial

The Effect of Tramadol on Interscalene Brachial Plexus Block

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