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

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM) (Other)

Overall Status

Terminated

CT.gov ID

NCT02247648

Collaborator

(none)

100

Enrollment

Location

Arms

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pain Vertigo Nausea Pruritus	Drug: tramadol Drug: Placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2013

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: treatment treatment: tramadol group	Drug: tramadol Patients from tramadol group received tramadol 100 mg day one, 100 mg day 2, and 200 mg day 3 Other Names: tridural
Placebo Comparator: control control: placebo group	Drug: Placebo Patients from control group received a "shame" tramadol pill on day one, two, and 3

Arm

Intervention/Treatment

Experimental: treatment

treatment: tramadol group

Drug: tramadol

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

Other Names:

tridural

Placebo Comparator: control

control: placebo group

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

quantity of hydromorphone consumed [3 days]
determination of the quantity of hydromorphone consumed at different laps

Secondary Outcome Measures

evaluation of pain (The intensity of pain was evaluated on a visual analog scale) [3 days]
evaluation of the pain at different laps

Other Outcome Measures

nausea [3 days]
dizziness [3 days]
pruritus [3 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut de chirurgie spécialisée de Montréal	Montréal	Quebec	Canada	h3s 2w1

Sponsors and Collaborators

Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

Principal Investigator: Jean-Denis Roy, Doctor, Head of the Anesthesia Department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre hospitalier de l'Université de Montréal (CHUM)

ClinicalTrials.gov Identifier:

NCT02247648

Other Study ID Numbers:

unique Protocol ID

First Posted:

Sep 25, 2014

Last Update Posted:

Jul 24, 2020

Last Verified:

Feb 1, 2018

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM)

BUPRENORPHINE/HYDROMORPHONE [VA Drug Interaction]

Additional relevant MeSH terms:

Vertigo

Pruritus

Tramadol

Study Results

No Results Posted as of Jul 24, 2020