Chloroprocaine for Inguinal Herniorrhaphy

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 After the spinal needle is withdrawn, an epidural catheter will be placed and the epidural needle will be withdrawn.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

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

Conditions
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Spinal Anesthesia

Intervention / Treatment
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* Drug: Chloroprocaine 1% Injectable Solution


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Interventional Model Description: Prospective, up-down sequential allocation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chloroprocaine 1% injectable solution<br>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. | Drug: Chloroprocaine 1% Injectable Solution<br>* 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.<br>* Other names: chloroprocaine 3%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The dose of chloroprocaine 1% needed for the individual patient for a sensory anesthesia block at or above the T6 dermatome | MLAD of chloroprocaine 1% with 2,5 mcg of sufentanil needed for the individual patient required for a sensory anesthesia at or above the T6 dermatome at the beginning of surgery with no additional epidural anesthesia required during surgery | start of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak block height | highest sensible block | during surgery | 
| Time for regression of two segments | Time for regression of two segments | during surgery | 
| Ambulation time | motor recovery | From starting hour of spinal anesthesia to hour of first ambulation after the end of surgery measured up to 6 hours after surgery | 
| Time to micturition | Time to micturition | From starting hour of spinal anesthesia to hour of first micturition after the end of surgery measured up to 6 hours after surgery | 
| Incidence of side effects (perioperative hypotension, respiratory depression, neurologic deficits) | Incidence of side effects (perioperative hypotension, respiratory depression, neurologic deficits) | perioperative | 
| Time to discharge | Time to discharge | From starting hour of spinal anesthesia to hour of discharge from hospital measured up to 6 hours after surgery | 
| Patient satisfaction with anesthesia method: questionnaire | Patient satisfaction with simple questionnair (highly satisfied, satisfied, unsatisfied) | postoperatively,at moment of hospital discharge measured up to 6 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chloroprocaine, spinal anesthesia, one-day clinic