Comparision of the Use in Marcaine and Chloroprocaine in... | NCT02049255

Studies
Comparision of the Use in Marcaine and Chloroprocaine in Rachianesthesia for the Surgical Correction of Inguinal Hernia.

NCT02049255

Sponsor

Astes

Status

Completed

Last Update Posted

Nov 3, 2014Estimated

Enrollment

50Actual

Phase

Phase 4

Conditions

Pain

Interventions

Chloroprocaine
Marcaine

Countries

Belgium

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

Oct 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Oct 2014Actual

Completion Date

Oct 2014Actual

First Submitted Date

Jan 24, 2014

First Submission Date that Met QC Criteria

Jan 29, 2014

First Posted Date

Jan 30, 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

Oct 31, 2014

Last Update Posted Date

Nov 3, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Comparison the use of marcaine and chloroprocaine in rachianesthesia for a surgical correction of inguinal hernia. Comparision between acute and chronic (3 months and 6 months) pain.

Detailed Description

Not provided

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Marcaine	Placebo Comparator	Rachianesthesia with marcaine or chloroprocaine	Drug: Marcaine
Chloroprocaine	Active Comparator	Rachianesthesia with marcaine or chloroprocaine	Drug: Chloroprocaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chloroprocaine	Drug	The Group "Chloroprocaine" will receive: Chloroprocaine: 50 mg in rachianesthesia	Chloroprocaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acute pain		1 day of the surgery when patient leave the recovery room

Secondary Outcomes

Measure	Description	Time Frame
Chronic pain		at 3 and 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults under rachianesthesia

Exclusion Criteria:

Personal history of gastric ulcus
ASA 4
Emergency
Combined surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric P Deflandre, MD, FCCP	Astes	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinique Saint-Luc Bouge		Bouge	Namur	5004	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D007945	Leukemia, Lymphoid

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C004616	chloroprocaine
D002045	Bupivacaine

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided