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Chloroprocaine for Inguinal Herniorrhaphy

Sponsor
University Hospital, Ghent (Other)
Overall Status
Completed
CT.gov ID
NCT03805503
Collaborator
(none)
12
Enrollment
1
Arm
38.6
Actual Duration (Months)

Study Details

Study Description

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 After the spinal needle is withdrawn, an epidural catheter will be placed and the epidural needle will be withdrawn.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

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Intervention Model:
Sequential Assignment
Intervention Model Description:
Prospective, up-down sequential allocationProspective, 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 :
Sep 16, 2015
Actual Primary Completion Date :
Sep 7, 2017
Actual Study Completion Date :
Dec 4, 2018

Arms and Interventions

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 Names:
  • chloroprocaine 3%

    		•

    Outcome Measures

    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 [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 [during surgery]

      highest sensible block

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

      Time for regression of two segments

    3. Ambulation time [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 [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) [perioperative]

      Incidence of side effects (perioperative hypotension, respiratory depression, neurologic deficits)

    6. Time to discharge [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 [postoperatively,at moment of hospital discharge measured up to 6 hours after surgery]

      Patient satisfaction with simple questionnair (highly satisfied, satisfied, unsatisfied)

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital, Ghent

    Investigators

    • Principal Investigator: Aliaksandra Parashchanka, MD, stafmember department of Anesthesiology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Ghent
    ClinicalTrials.gov Identifier:
    NCT03805503
    Other Study ID Numbers:
    • EC/2014/1264
    First Posted:
    Jan 15, 2019
    Last Update Posted:
    Jan 15, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Chloroprocaine
    Procaine

    Study Results

    No Results Posted as of Jan 15, 2019