Determination of the minimum local anesthetic dose (MLAD) of spinal chloroprocaine for inguinal herniorrhaphy in ambulatory surgery.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005469-58-BE

Enrollment

Registered

2014-12-16

Start date

2015-01-14

Completion date

Unknown

Last updated

2018-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal herniorrhaphy. MedDRA version: 17.1 Level: PT Classification code 10022020 Term: Inguinal hernia repair System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Ampres 10 mg/ml oplossing voor injectie. Product Name: Chloorprocaïnehydrochloride Pharmaceutical Form: Solution for injection INN or Proposed INN: CHLOROPROCAINE HYDROCHLORIDE CAS Number:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Outpatients for unilateral inguinal hernia repair • ASA I - II - III Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary goal of this study is to determine the minimum effective dose for intrathecal chloroprocaine in inguinal herniorrhaphy in outpatients using a Combined Spinal Epidural (CSE) anesthesia. ;Secondary Objective: - Peak block height - Time for regression of two segments - Length of analgesia (the time from the last dose of local anaesthetic administered intrathecally to VAS>3) - Ambulation time - Time to micturition - Incidence of side effects (perioperative hypotension, respiratory depression, neurologic deficits) - Time to discharge - Patient satisfaction ;Primary end point(s): MLAD of chloroprocaine 1% with 2,5 mcg of sufentanil required for a sensory anesthesia at or above the T6 dermatome with no additional epidural anesthesia required during surgery.;Timepoint(s) of evaluation of this end point: At the beginning of surgery.	—

Measure

Time frame

Main Objective: The primary goal of this study is to determine the minimum effective dose for intrathecal chloroprocaine in inguinal herniorrhaphy in outpatients using a Combined Spinal Epidural (CSE) anesthesia. ;Secondary Objective: - Peak block height - Time for regression of two segments - Length of analgesia (the time from the last dose of local anaesthetic administered intrathecally to VAS>3) - Ambulation time - Time to micturition - Incidence of side effects (perioperative hypotension, respiratory depression, neurologic deficits) - Time to discharge - Patient satisfaction ;Primary end point(s): MLAD of chloroprocaine 1% with 2,5 mcg of sufentanil required for a sensory anesthesia at or above the T6 dermatome with no additional epidural anesthesia required during surgery.;Timepoint(s) of evaluation of this end point: At the beginning of surgery.

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Secondary

Measure	Time frame
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None	—

Countries

Belgium

Contacts

Public ContactBimetra Clinics

Ghent University Hospital

Bimetra.Clinics@uzgent.be+3293320500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026