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NCT02049255 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02049255
Other study ID # AMBES-ASTES-2013
Secondary ID
Status Completed
Phase Phase 4
First received January 24, 2014
Last updated October 31, 2014
Start date November 2013
Est. completion date October 2014

Study information
Verified date October 2014
Source Astes
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health Products
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adults under rachianesthesia

Exclusion Criteria:

- Personal history of gastric ulcus

- ASA 4

- Emergency

- Combined surgery

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Chloroprocaine
The Group "Chloroprocaine" will receive: Chloroprocaine: 50 mg in rachianesthesia
• Marcaine
The Group "Marcaine" will receive: Marcaine: 12,5 mg in rachianesthesia

Locations
Country Name City State
Belgium Clinique Saint-Luc Bouge Bouge Namur

Sponsors (1)
Lead Sponsor Collaborator
Astes

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Acute pain 1 day of the surgery when patient leave the recovery room No
Secondary Chronic pain at 3 and 6 months No
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