Clinical trial NCT03805503: Chloroprocaine for Inguinal Herniorrhaphy
Official title: Determination of the Minimum Local Anesthetic Dose (MLAD) of Spinal Chloroprocaine for Inguinal Herniorrhaphy in Ambulatory Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spinal Anesthesia
Keywords: Chloroprocaine
spinal anesthesia
one-day clinic
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Intervention model description: Prospective, up-down sequential allocation
Primary purpose: TREATMENT

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 After the spinal needle is withdrawn, an epidural catheter will be placed and the epidural needle will be withdrawn.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

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)

Primary outcomes:
measure: The dose of chloroprocaine 1% needed for the individual patient for a sensory anesthesia block at or above the T6 dermatome
timeFrame: start of surgery
Secondary outcomes:
measure: Peak block height
timeFrame: during surgery
measure: Time for regression of two segments
timeFrame: during surgery
measure: Ambulation time
timeFrame: From starting hour of spinal anesthesia to hour of first ambulation after the end of surgery measured up to 6 hours after surgery
measure: Time to micturition
timeFrame: From starting hour of spinal anesthesia to hour of first micturition after the end of surgery measured up to 6 hours after surgery
measure: Incidence of side effects (perioperative hypotension, respiratory depression, neurologic deficits)
timeFrame: perioperative
measure: Time to discharge
timeFrame: From starting hour of spinal anesthesia to hour of discharge from hospital measured up to 6 hours after surgery
measure: Patient satisfaction with anesthesia method: questionnaire
timeFrame: postoperatively,at moment of hospital discharge measured up to 6 hours after surgery
Other outcomes:
Locations:
Study officials:
affiliation: stafmember department of Anesthesiology
name: Aliaksandra Parashchanka, MD
role: PRINCIPAL_INVESTIGATOR
References: