Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-02-23 @ 11:34 AM
Study NCT ID:
NCT03805503
Status:
COMPLETED
Last Update Posted:
2019-01-15
First Post:
2018-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chloroprocaine for Inguinal Herniorrhaphy
Sponsor:
University Hospital, Ghent
Organization:
Study Overview
Official Title:
Determination of the Minimum Local Anesthetic Dose (MLAD) of Spinal Chloroprocaine for Inguinal Herniorrhaphy in Ambulatory Surgery
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 After the spinal needle is withdrawn, an epidural catheter will be placed and the epidural needle will be withdrawn.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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: