Chloroprocaine for Inguinal Herniorrhaphy
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|ClinicalTrials.gov Identifier: NCT03805503|
Recruitment Status : Completed
First Posted : January 15, 2019
Last Update Posted : January 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Spinal Anesthesia||Drug: Chloroprocaine 1% Injectable Solution||Phase 4|
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 After the spinal needle is withdrawn, an epidural catheter will be placed and the epidural needle will be withdrawn.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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Prospective, up-down sequential allocation|
|Masking:||None (Open Label)|
|Official Title:||Determination of the Minimum Local Anesthetic Dose (MLAD) of Spinal Chloroprocaine for Inguinal Herniorrhaphy in Ambulatory Surgery|
|Actual Study Start Date :||September 16, 2015|
|Actual Primary Completion Date :||September 7, 2017|
|Actual Study Completion Date :||December 4, 2018|
Experimental: 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.
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.
Other Name: chloroprocaine 3%
- The dose of chloroprocaine 1% needed for the individual patient for a sensory anesthesia block at or above the T6 dermatome [ Time Frame: start of surgery ]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
- Peak block height [ Time Frame: during surgery ]highest sensible block
- Time for regression of two segments [ Time Frame: during surgery ]Time for regression of two segments
- Ambulation time [ Time Frame: From starting hour of spinal anesthesia to hour of first ambulation after the end of surgery measured up to 6 hours after surgery ]motor recovery
- Time to micturition [ Time Frame: From starting hour of spinal anesthesia to hour of first micturition after the end of surgery measured up to 6 hours after surgery ]Time to micturition
- Incidence of side effects (perioperative hypotension, respiratory depression, neurologic deficits) [ Time Frame: perioperative ]Incidence of side effects (perioperative hypotension, respiratory depression, neurologic deficits)
- Time to discharge [ Time Frame: From starting hour of spinal anesthesia to hour of discharge from hospital measured up to 6 hours after surgery ]Time to discharge
- Patient satisfaction with anesthesia method: questionnaire [ Time Frame: postoperatively,at moment of hospital discharge measured up to 6 hours after surgery ]Patient satisfaction with simple questionnair (highly satisfied, satisfied, unsatisfied)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805503
|Principal Investigator:||Aliaksandra Parashchanka, MD||stafmember department of Anesthesiology|