Determination of the minimum local anesthetic dose (MLAD) of spinal chloroprocaine for inguinal herniorrhaphy in ambulatory surgery.

Phase 1

Conditions: Inguinal herniorrhaphy.
MedDRA version: 17.1Level: PTClassification code 10022020Term: Inguinal hernia repairSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2014-005469-58-BE

Lead Sponsor: Ghent University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

•Outpatients for unilateral inguinal hernia repair
•ASA I - II - III

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

•hypersensitivity to amino-ester local anesthetics, para-aminobenzoic acid or sufentanil
•contraindications to spinal or epidural anesthesia
•bilateral inguinal herniorrhaphy
•extremes of height and weight (BMI 20 or 35 kg/m2, height 150 cm or 185 cm)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary goal of this study is to determine the minimum effective dose for intrathecal chloroprocaine in inguinal herniorrhaphy in outpatients using a Combined Spinal Epidural (CSE) anesthesia. ;Secondary Objective: -Peak block height<br>-Time for regression of two segments<br>-Length of analgesia (the time from the last dose of local anaesthetic administered intrathecally to VAS>3) <br>-Ambulation time<br>-Time to micturition<br>-Incidence of side effects (perioperative hypotension, respiratory depression, neurologic deficits) <br>-Time to discharge<br>-Patient satisfaction <br>;Primary end point(s): MLAD of chloroprocaine 1% with 2,5 mcg of sufentanil required for a sensory anesthesia at or above the T6 dermatome with no additional epidural anesthesia required during surgery.;Timepoint(s) of evaluation of this end point: At the beginning of surgery.

Secondary Outcome Measures