NCT02247648

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2 pain

Timeline
Completed

Started Jun 2013

Longer than P75 for phase_2 pain

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 24, 2020

Status Verified

February 1, 2018

Enrollment Period

4.5 years

First QC Date

September 15, 2014

Last Update Submit

July 22, 2020

Conditions

PainVertigoNauseaPruritus

Keywords

tramadolshoulder surgerypaininterscalen blockBUPRENORPHINE/HYDROMORPHONE [VA Drug Interaction]

Outcome Measures

Primary Outcomes (1)

  • quantity of hydromorphone consumed

    determination of the quantity of hydromorphone consumed at different laps

    3 days

Secondary Outcomes (1)

  • evaluation of pain (The intensity of pain was evaluated on a visual analog scale)

    3 days

Other Outcomes (3)

  • nausea

    3 days

  • dizziness

    3 days

  • pruritus

    3 days

Study Arms (2)

treatment

EXPERIMENTAL

treatment: tramadol group

Drug: tramadol

control

PLACEBO COMPARATOR

control: placebo group

Drug: Placebo

Interventions

tramadolDRUG

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

Also known as: tridural
treatment
PlaceboDRUG

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

control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged more than 18 year old
  • arthroscopic shoulder surgery on interscalen block
  • able to understand the protocol
  • inform consent signed

You may not qualify if:

  • chronic pain or chronic used of narcotics
  • Use of IMAO
  • Use of ISRS
  • Pulmonary chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de chirurgie spécialisée de Montréal

Montreal, Quebec, h3s 2w1, Canada

Location

MeSH Terms

Conditions

PainVertigoNauseaPruritus

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsVestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNervous System DiseasesSigns and Symptoms, DigestiveSkin DiseasesSkin and Connective Tissue DiseasesSkin Manifestations

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipids

Study Officials

  • Jean-Denis Roy, Doctor

    Head of the Anesthesia Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2014

First Posted

September 25, 2014

Study Start

June 1, 2013

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

July 24, 2020

Record last verified: 2018-02

Locations

CA(1)