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

Phase 2
Terminated
Conditions
Vertigo
Pruritus
Pain
Nausea
Interventions
Drug: Placebo
Registration Number
NCT02247648
Lead Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
100
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
controlPlacebocontrol: placebo group
treatmenttramadoltreatment: tramadol group
Primary Outcome Measures
NameTimeMethod
quantity of hydromorphone consumed3 days

determination of the quantity of hydromorphone consumed at different laps

Secondary Outcome Measures
NameTimeMethod
evaluation of pain (The intensity of pain was evaluated on a visual analog scale)3 days

evaluation of the pain at different laps

Trial Locations

Locations (1)

Institut de chirurgie spécialisée de Montréal

🇨🇦

Montréal, Quebec, Canada

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