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Trial record 44 of 452 for:    TRAMADOL

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

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ClinicalTrials.gov Identifier: NCT02247648
Recruitment Status : Unknown
Verified June 2013 by Luc Massicotte, Centre hospitalier de l'Université de Montréal (CHUM).
Recruitment status was:  Active, not recruiting
First Posted : September 25, 2014
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):
Luc Massicotte, Centre hospitalier de l'Université de Montréal (CHUM)

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.

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Study Type : Interventional  (Clinical Trial)
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
Study Start Date : June 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

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 Name: tridural

Placebo Comparator: control
control: placebo group
Drug: Placebo
Patients from control group received a "shame" tramadol pill on day one, two, and 3




Primary Outcome Measures :
  1. quantity of hydromorphone consumed [ Time Frame: 3 days ]
    determination of the quantity of hydromorphone consumed at different laps


Secondary Outcome Measures :
  1. evaluation of pain (The intensity of pain was evaluated on a visual analog scale) [ Time Frame: 3 days ]
    evaluation of the pain at different laps


Other Outcome Measures:
  1. nausea [ Time Frame: 3 days ]
  2. dizziness [ Time Frame: 3 days ]
  3. pruritus [ Time Frame: 3 days ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247648


Locations
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Canada, Quebec
Institut de chirurgie spécialisée de Montréal
Montréal, Quebec, Canada, h3s 2w1
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
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Principal Investigator: Jean-Denis Roy, Doctor Head of the Anesthesia Department

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Responsible Party: Luc Massicotte, Doctor, Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT02247648     History of Changes
Other Study ID Numbers: unique Protocol ID
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: June 2013
Keywords provided by Luc Massicotte, Centre hospitalier de l'Université de Montréal (CHUM):
tramadol
shoulder surgery
pain
interscalen block
BUPRENORPHINE/HYDROMORPHONE [VA Drug Interaction]
Additional relevant MeSH terms:
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Tramadol
Vertigo
Pruritus
Signs and Symptoms
Skin Diseases
Skin Manifestations
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents