Chloroprocaine for Inguinal Herniorrhaphy

NCT ID: NCT03805503

Last Updated: 2019-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-16
• Study Completion Date: 2018-12-04

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 After the spinal needle is withdrawn, an epidural catheter will be placed and the epidural needle will be withdrawn.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

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

chloroprocaine 1% injectable solution

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.

Group Type: EXPERIMENTAL

Chloroprocaine 1% Injectable Solution

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

chloroprocaine 3%

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aliaksandra Parashchanka, MD

Role: PRINCIPAL_INVESTIGATOR

stafmember department of Anesthesiology

Other Identifiers

EC/2014/1264

Identifier Type: -

Identifier Source: org_study_id