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

Primary Purpose

Pain

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Chloroprocaine
Marcaine
Sponsored by
Astes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring All

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults under rachianesthesia

Exclusion Criteria:

  • Personal history of gastric ulcus
  • ASA 4
  • Emergency
  • Combined surgery

Sites / Locations

  • Clinique Saint-Luc Bouge

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Marcaine

Chloroprocaine

Arm Description

Rachianesthesia with marcaine or chloroprocaine

Rachianesthesia with marcaine or chloroprocaine

Outcomes

Primary Outcome Measures

Acute pain

Secondary Outcome Measures

Chronic pain

Full Information

First Posted
January 24, 2014
Last Updated
October 31, 2014
Sponsor
Astes
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1. Study Identification

Unique Protocol Identification Number
NCT02049255
Brief Title
Comparision of the Use in Marcaine and Chloroprocaine in Rachianesthesia for the Surgical Correction of Inguinal Hernia.
Official Title
Comparision of the Use in Marcaine and Chloroprocaine in Rachianesthesia for the Surgical Correction of Inguinal Hernia.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Astes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
All

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Marcaine
Arm Type
Placebo Comparator
Arm Description
Rachianesthesia with marcaine or chloroprocaine
Arm Title
Chloroprocaine
Arm Type
Active Comparator
Arm Description
Rachianesthesia with marcaine or chloroprocaine
Intervention Type
Drug
Intervention Name(s)
Chloroprocaine
Intervention Description
The Group "Chloroprocaine" will receive: Chloroprocaine: 50 mg in rachianesthesia
Intervention Type
Drug
Intervention Name(s)
Marcaine
Intervention Description
The Group "Marcaine" will receive: Marcaine: 12,5 mg in rachianesthesia
Primary Outcome Measure Information:
Title
Acute pain
Time Frame
1 day of the surgery when patient leave the recovery room
Secondary Outcome Measure Information:
Title
Chronic pain
Time Frame
at 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults under rachianesthesia Exclusion Criteria: Personal history of gastric ulcus ASA 4 Emergency Combined surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric P Deflandre, MD, FCCP
Organizational Affiliation
Astes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Saint-Luc Bouge
City
Bouge
State/Province
Namur
ZIP/Postal Code
5004
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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