The Effect of Tramadol on Interscalene Brachial Plexus Block

January 2, 2016 updated by: Eleftheria Soulioti, Asklepieion Voulas General Hospital

The Effect of Tramadol on Interscalene Brachial Plexus Block With Ropivacaine in Shoulder Surgery.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Attica
      • Athens, Attica, Greece, 16673
        • Asklepieion Hospital of Voula

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Shoulder surgery

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative analgesia
Time Frame: 24 hours postoperatively
24 hours postoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asklepieion Voulas General Hospital

Collaborators

Aretaieion University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

June 30, 2014

First Submitted That Met QC Criteria

July 2, 2014

First Posted (Estimate)

July 8, 2014

Study Record Updates

Last Update Posted (Estimate)

January 5, 2016

Last Update Submitted That Met QC Criteria

January 2, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3694/27-3-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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