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

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02247648
Enrollment
100
Registered
2014-09-25
Start date
2013-06-30
Completion date
2017-12-31
Last updated
2020-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea, Pain, Pruritus, Vertigo

Keywords

tramadol, shoulder surgery, pain, interscalen block, BUPRENORPHINE/HYDROMORPHONE [VA Drug Interaction]

Brief summary

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

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.

Interventions

DRUGtramadol

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

DRUGPlacebo

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

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frameDescription
quantity of hydromorphone consumed3 daysdetermination of the quantity of hydromorphone consumed at different laps

Secondary

MeasureTime frameDescription
evaluation of pain (The intensity of pain was evaluated on a visual analog scale)3 daysevaluation of the pain at different laps

Other

MeasureTime frame
nausea3 days
dizziness3 days
pruritus3 days

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026