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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

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.

Condition or disease Intervention/treatment Phase
Spinal Anesthesia Drug: Chloroprocaine 1% Injectable Solution Phase 4

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 After the spinal needle is withdrawn, an epidural catheter will be placed and the epidural needle will be withdrawn.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


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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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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%




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Peak block height [ Time Frame: during surgery ]
    highest sensible block

  2. Time for regression of two segments [ Time Frame: during surgery ]
    Time for regression of two segments

  3. 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

  4. 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

  5. Incidence of side effects (perioperative hypotension, respiratory depression, neurologic deficits) [ Time Frame: perioperative ]
    Incidence of side effects (perioperative hypotension, respiratory depression, neurologic deficits)

  6. 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

  7. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Sponsors and Collaborators
University Hospital, Ghent
Investigators
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Principal Investigator: Aliaksandra Parashchanka, MD stafmember department of Anesthesiology

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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT03805503     History of Changes
Other Study ID Numbers: EC/2014/1264
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Ghent:
Chloroprocaine
spinal anesthesia
one-day clinic
Additional relevant MeSH terms:
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Chloroprocaine
Procaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents