Trial intelligence / Profile preview

MLAD of Spinal Chloroprocaine for Inguinal Herniorrhaphy

NCT03805503Phase 4

Key facts

Status: Completed
Start: Sep 2015
Primary completion: Sep 2017
Sponsor: Ghent University Hospital
Modality: Small Molecules

Drugs: chloroprocaine
Conditions: inguinal hernia

Overview

Phase 4, open-label, single-arm trial of chloroprocaine in inguinal hernia, sponsored by Ghent University Hospital. Primary endpoint: Minimum Local Anesthetic Dose of chloroprocaine 1%. Started Sep 2015; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Chloroprocaine Dose Finding
Sequential allocation of chloroprocaine dose (starting 50mg, +/- 2mg steps) + fixed sufentanil

Who it enrols

Outpatients for unilateral inguinal hernia repair with BMI 20-35 kg/m2 and height 150-185 cm, excluding those with hypersensitivity to study drugs or contraindications to spinal/epidural anesthesia.

Endpoints

Primary

Minimum Local Anesthetic Dose of chloroprocaine 1%start of surgery

Secondary

Peak block heightduring surgery
Time for regression of two segmentsduring surgery
Ambulation timeup to 6 hours after surgery
Time to micturitionup to 6 hours after surgery
Incidence of side effectsperioperative
Time to dischargeup to 6 hours after surgery
Patient satisfaction with anesthesia methodat discharge

Beyond the preview

Go deeper on NCT03805503.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT03805503.