Efficacy of Extended-release, Once Daily Tramadol for Post Operative Analgesia in Shoulder Arthroscopy

July 22, 2020 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

Efficacy of Extended-release, Once Daily Tramadol for Post Operative in Ambulatory Shoulder Arthroscopy

The investigators hypothesize that the use of tramadol will reduce pain and analgesic consumption after arthroscopic shoulder surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The purpose of the study was to evaluate the efficacy of tramadol long acting for post operative pain in patients who had an arthroscopic shoulder surgery in ambulatory setting in comparison with a placebo. The intensity of pain was evaluated on a visual analog scale as the quantity of hydromorphone taken by patients, and the side effects during the first 72 hours.

Study Type

Interventional

Enrollment (Actual)

100

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

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, h3s 2w1
        • Institut de chirurgie spécialisée de Montréal

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged more than 18 year old
  • arthroscopic shoulder surgery on interscalen block
  • able to understand the protocol
  • inform consent signed

Exclusion Criteria:

  • chronic pain or chronic used of narcotics
  • Use of IMAO
  • Use of ISRS
  • Pulmonary chronic disease

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment
treatment: tramadol group
Drug: tramadol
Patients from tramadol group received tramadol 100 mg day one, 100 mg day 2, and 200 mg day 3
Other Names:
  • tridural
Placebo Comparator: control
control: placebo group
Drug: Placebo
Patients from control group received a "shame" tramadol pill on day one, two, and 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quantity of hydromorphone consumed
Time Frame: 3 days
determination of the quantity of hydromorphone consumed at different laps
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of pain (The intensity of pain was evaluated on a visual analog scale)
Time Frame: 3 days
evaluation of the pain at different laps
3 days

Other Outcome Measures

Outcome Measure
Time Frame
nausea
Time Frame: 3 days
3 days
dizziness
Time Frame: 3 days
3 days
pruritus
Time Frame: 3 days
3 days

Collaborators and Investigators

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

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

  • Principal Investigator: Jean-Denis Roy, Doctor, Head of the Anesthesia Department

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 (Actual)

June 1, 2013

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

September 15, 2014

First Submitted That Met QC Criteria

September 23, 2014

First Posted (Estimate)

September 25, 2014

Study Record Updates

Last Update Posted (Actual)

July 24, 2020

Last Update Submitted That Met QC Criteria

July 22, 2020

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Unique protocol ID (Other Identifier: AUSL Piacenza)

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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