Skip to main content
OpenTrials
Completed

NCT Number: NCT03805503

Chloroprocaine for Inguinal Herniorrhaphy

This study is to determine the minimum effective dose for intrathecal chloroprocaine in inguinal herniorrhaphy in outpatients using a Combined Spinal Epidural (CSE) anesthesia.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spinal Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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 After the spinal needle is withdrawn, an epidural catheter will be placed and the epidural needle will be withdrawn.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Chloroprocaine 1% Injectable Solution

Drug

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%

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jan 15, 2019
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.