NCT02247648
Terminated
Phase 2
Efficacy of Extended-release, Once Daily Tramadol for Post Operative in Ambulatory Shoulder Arthroscopy
Centre hospitalier de l'Université de Montréal (CHUM)1 site in 1 country100 target enrollmentJune 2013
Overview
- Phase
- Phase 2
- Intervention
- tramadol
- Conditions
- Pain
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- quantity of hydromorphone consumed
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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.
Investigators
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
Arms & Interventions
treatment
treatment: tramadol group
Intervention: tramadol
control
control: placebo group
Intervention: Placebo
Outcomes
Primary Outcomes
quantity of hydromorphone consumed
Time Frame: 3 days
determination of the quantity of hydromorphone consumed at different laps
Secondary Outcomes
- evaluation of pain (The intensity of pain was evaluated on a visual analog scale)(3 days)
Study Sites (1)
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