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

Phase 2TerminatedNCT02247648

Centre hospitalier de l'Université de Montréal (CHUM)100 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Pain Vertigo Nausea Pruritus

Interventions

tramadolDRUG

Patients from tramadol group received tramadol 100 mg day one, 100 mg day 2, and 200 mg day 3

PlaceboDRUG

Patients from control group received a "shame" tramadol pill on day one, two, and 3

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Institut de chirurgie spécialisée de Montréal

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

quantity of hydromorphone consumed

determination of the quantity of hydromorphone consumed at different laps

Time frame: 3 days

Secondary Outcomes

evaluation of pain (The intensity of pain was evaluated on a visual analog scale)

evaluation of the pain at different laps

Time frame: 3 days

Data from ClinicalTrials.gov

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