Overview

This trial is active, not recruiting.

Conditions pain, vertigo, nausea, pruritus
Treatments tramadol, placebo
Phase phase 2
Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Start date June 2013
End date December 2014
Trial size 100 participants
Trial identifier NCT02247648, unique Protocol ID

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
treatment: tramadol group
tramadol tridural
Patients from tramadol group received tramadol 100 mg day one, 100 mg day 2, and 200 mg day 3
(Placebo Comparator)
control: placebo group
placebo Placebo
Patients from control group received a "shame" tramadol pill on day one, two, and 3

Primary Outcomes

Measure
quantity of hydromorphone consumed
time frame: 3 days

Secondary Outcomes

Measure
evaluation of pain (The intensity of pain was evaluated on a visual analog scale)
time frame: 3 days

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Efficacy of Extended-release, Once Daily Tramadol for Post Operative in Ambulatory Shoulder Arthroscopy
Principal investigator Jean-Denis Roy, Doctor
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM).