Chloroprocaine for Inguinal Herniorrhaphy

NCT03805503 | Completed Phase 4 DMC

• 1 other identifier: EC/2014/1264
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Anesthesia

Keywords

Chloroprocaine; spinal anesthesia; one-day clinic

Outcome Measures

Primary Outcomes (1)

• The dose of chloroprocaine 1% needed for the individual patient for a sensory anesthesia block at or above the T6 dermatome

  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 Outcomes (7)

• Peak block height

  during surgery

• Time for regression of two segments

  during surgery

• 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

• 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)

  perioperative

Study Arms (1)

chloroprocaine 1% injectable solution

EXPERIMENTAL

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

Interventions

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.

Also known as: chloroprocaine 3%

chloroprocaine 1% injectable solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients for unilateral inguinal hernia repair
• ASA I - II - III

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Ghent: lead

MeSH Terms

Interventions

chloroprocaine

Study Officials

• Aliaksandra Parashchanka, MD

  stafmember department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, up-down sequential allocation

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: January 15, 2019
• Study Start: September 16, 2015
• Primary Completion: September 7, 2017
• Study Completion: December 4, 2018
• Last Updated: January 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share