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

Primary Purpose

Pain, Vertigo, Nausea

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
tramadol
Placebo
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring tramadol, shoulder surgery, pain, interscalen block, BUPRENORPHINE/HYDROMORPHONE [VA Drug Interaction]

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Institut de chirurgie spécialisée de Montréal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

treatment

control

Arm Description

treatment: tramadol group

control: placebo group

Outcomes

Primary Outcome Measures

quantity of hydromorphone consumed
determination of the quantity of hydromorphone consumed at different laps

Secondary Outcome Measures

evaluation of pain (The intensity of pain was evaluated on a visual analog scale)
evaluation of the pain at different laps

Full Information

First Posted
September 15, 2014
Last Updated
July 22, 2020
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT02247648
Brief Title
Efficacy of Extended-release, Once Daily Tramadol for Post Operative Analgesia in Shoulder Arthroscopy
Official Title
Efficacy of Extended-release, Once Daily Tramadol for Post Operative in Ambulatory Shoulder Arthroscopy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Study Start Date
June 2013 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Vertigo, Nausea, Pruritus
Keywords
tramadol, shoulder surgery, pain, interscalen block, BUPRENORPHINE/HYDROMORPHONE [VA Drug Interaction]

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment
Arm Type
Experimental
Arm Description
treatment: tramadol group
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
control: placebo group
Intervention Type
Drug
Intervention Name(s)
tramadol
Other Intervention Name(s)
tridural
Intervention Description
Patients from tramadol group received tramadol 100 mg day one, 100 mg day 2, and 200 mg day 3
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients from control group received a "shame" tramadol pill on day one, two, and 3
Primary Outcome Measure Information:
Title
quantity of hydromorphone consumed
Description
determination of the quantity of hydromorphone consumed at different laps
Time Frame
3 days
Secondary Outcome Measure Information:
Title
evaluation of pain (The intensity of pain was evaluated on a visual analog scale)
Description
evaluation of the pain at different laps
Time Frame
3 days
Other Pre-specified Outcome Measures:
Title
nausea
Time Frame
3 days
Title
dizziness
Time Frame
3 days
Title
pruritus
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Denis Roy, Doctor
Organizational Affiliation
Head of the Anesthesia Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de chirurgie spécialisée de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
h3s 2w1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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