Efficacy of Extended-release, Once Daily Tramadol for Pos... | NCT02247648

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

NCT02247648

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Status

Terminated

Last Update Posted

Jul 24, 2020Actual

Enrollment

100Actual

Phase

Phase 2

Conditions

Pain
Vertigo
Nausea
Pruritus

Interventions

tramadol
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013Actual

Primary Completion Date

Dec 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

Sep 15, 2014

First Submission Date that Met QC Criteria

Sep 23, 2014

First Posted Date

Sep 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2020

Last Update Posted Date

Jul 24, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
treatment	Experimental	treatment: tramadol group	Drug: tramadol
control	Placebo Comparator	control: placebo group	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tramadol	Drug	Patients from tramadol group received tramadol 100 mg day one, 100 mg day 2, and 200 mg day 3	treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
quantity of hydromorphone consumed	determination of the quantity of hydromorphone consumed at different laps	3 days

Secondary Outcomes

Measure	Description	Time Frame
evaluation of pain (The intensity of pain was evaluated on a visual analog scale)	evaluation of the pain at different laps	3 days

Other Outcomes

Measure	Description	Time Frame
nausea		3 days
dizziness		3 days
pruritus		3 days

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Denis Roy, Doctor	Head of the Anesthesia Department	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut de chirurgie spécialisée de Montréal		Montreal	Quebec	h3s 2w1	Canada

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D014717	Vertigo
D009325	Nausea
D011537	Pruritus

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D015837	Vestibular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014147	Tramadol

Ancestor Terms

ID	Term
D003511	Cyclohexanols
D000441	Hexanols
D005233	Fatty Alcohols
D000438	Alcohols
D009930

Browse Leaves

Not provided

Browse Branches

Not provided