Chloroprocaine for Inguinal Herniorrhaphy

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 4

Conditions: Spinal Anesthesia

Treatments: Drug: Chloroprocaine 1% Injectable Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03805503

EC/2014/1264

Details and patient eligibility

About

This study is to determine the minimum effective dose for intrathecal chloroprocaine in inguinal herniorrhaphy in outpatients using a Combined Spinal Epidural (CSE) anesthesia.

Full description

A standard CSE procedure will be conducted in which the patient is placed in an upright sitting position on the side of the operation table and a epidural Tuohy needle 18G will be inserted into L3-L4 interspace via a loss-of-resistance technique. The dura will be punctured using a 27-gauge pencil-point spinal needle and a certain dose of chloroprocaine 1% will be given. After the spinal needle is withdrawn, an epidural catheter will be placed and the epidural needle will be withdrawn. After fixation of catheter the patient will be placed in a supine position.

The first spinal dose of chloroprocaine 1% to start with is 50mg. This dose has been successfully used for spinal anesthesia in hernia repair outpatients to reach an adequate analgesia. Each time there will be added 2,5 microgram of sufentanil for prolongation of the analgesia. The testing interval is 2 mg.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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)

Trial design

12 participants in 1 patient group

chloroprocaine 1% injectable solution

Experimental group

Description:

Prospective, up-down sequential allocation : first patient receives 50mg intrathecal chloroprocaine 1%. An effective result will decrease the test dose of chloroprocaine with 2 mg for the next patient in this study. An ineffective result will increase the test dose of chloroprocaine with 2 mg for the next patient in this study.

Treatment:

Drug: Chloroprocaine 1% Injectable Solution