NCT03805503

Chloroprocaine for Inguinal Herniorrhaphy

Determination of the Minimum Local Anesthetic Dose (MLAD) of Spinal Chloroprocaine for Inguinal Herniorrhaphy in Ambulatory Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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 After the spinal needle is withdrawn, an epidural catheter will be placed and the epidural needle will be withdrawn.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.

Conditions

• Spinal Anesthesia

Interventions

Type	Name	Description
DRUG	Chloroprocaine 1% Injectable Solution	standard CSE procedure in outpatients for inguinal hernia. 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. 2,5 microgram of sufentanil will be added for prolongation of the analgesia. The testing interval is 2 mg. Efficacy of the analgesia will be evaluated: Successful : sensory block at or above T6 dermatome bilateral at the beginning of surgery without additional analgesia during surgery. Unsuccessful: sensory block under T6 dermatome bilateral and/or VAPS is more than 10 mm at the beginning of surgery what necessitates additional epidurals analgesia. Patients who indicate an ineffective result will receive a rescue treatment by the administration of 5 ml chloroprocaine 3% epidural every 5 minutes with maximum of 30ml. When CSE fails, general anesthesia will be performed.

Timeline

• Start date: 2015-09-16
• Primary completion: 2017-09-07
• Completion: 2018-12-04
• First posted: 2019-01-15
• Last updated: 2019-01-15