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

October 31, 2014 updated by: Eric DEFLANDRE, MD, FCCP, Astes
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Namur
      • Bouge, Namur, Belgium, 5004
        • Clinique Saint-Luc Bouge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults under rachianesthesia

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Marcaine
Rachianesthesia with marcaine or chloroprocaine
Drug: Marcaine
The Group "Marcaine" will receive: Marcaine: 12,5 mg in rachianesthesia
Active Comparator: Chloroprocaine
Rachianesthesia with marcaine or chloroprocaine
Drug: Chloroprocaine
The Group "Chloroprocaine" will receive: Chloroprocaine: 50 mg in rachianesthesia

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Chronic pain
Time Frame: at 3 and 6 months
at 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

January 24, 2014

First Submitted That Met QC Criteria

January 29, 2014

First Posted (Estimate)

January 30, 2014

Study Record Updates

Last Update Posted (Estimate)

November 2, 2014

Last Update Submitted That Met QC Criteria

October 31, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMBES-ASTES-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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