Chloroprocaine for Inguinal Herniorrhaphy

January 14, 2019 updated by: University Hospital, Ghent

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

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

Study Overview

Status

Completed

Conditions

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 After the spinal needle is withdrawn, an epidural catheter will be placed and the epidural needle will be withdrawn.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

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

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%

What is the study measuring?

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
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
start of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak block height
Time Frame: during surgery
highest sensible block
during surgery
Time for regression of two segments
Time Frame: during surgery
Time for regression of two segments
during surgery
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
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 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
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)
Time Frame: perioperative
Incidence of side effects (perioperative hypotension, respiratory depression, neurologic deficits)
perioperative
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
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
Time Frame: postoperatively,at moment of hospital discharge measured up to 6 hours after surgery
Patient satisfaction with simple questionnair (highly satisfied, satisfied, unsatisfied)
postoperatively,at moment of hospital discharge measured up to 6 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2015

Primary Completion (Actual)

September 7, 2017

Study Completion (Actual)

December 4, 2018

Study Registration Dates

First Submitted

December 4, 2018

First Submitted That Met QC Criteria

January 14, 2019

First Posted (Actual)

January 15, 2019

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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