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

Centre hospitalier de l'Université de Montréal (CHUM)

Status and phase: Terminated; Phase 2

Conditions: Nausea; Vertigo; Pain; Pruritus

Treatments: Drug: tramadol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02247648

unique Protocol ID

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

treatment

Experimental group

Description:

treatment: tramadol group

Treatment:

Drug: tramadol

control

Placebo Comparator group

Description:

control: placebo group

Treatment:

Drug: Placebo