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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02247648
• Other study ID #: unique Protocol ID
• Status: Terminated
• Phase: Phase 2
• Start date: June 2013
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Pain
• Pruritus
• Vertigo

Intervention

Drug:
• tramadol
Patients from tramadol group received tramadol 100 mg day one, 100 mg day 2, and 200 mg day 3
• Placebo
Patients from control group received a "shame" tramadol pill on day one, two, and 3

Locations

Country	Name	City	State
Canada	Institut de chirurgie spécialisée de Montréal	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	nausea		3 days
Other	dizziness		3 days
Other	pruritus		3 days
Primary	quantity of hydromorphone consumed	determination of the quantity of hydromorphone consumed at different laps	3 days
Secondary	evaluation of pain (The intensity of pain was evaluated on a visual analog scale)	evaluation of the pain at different laps	3 days