increased efficacy of lidocaine when amitriptyline is added for local anaesthesia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005555-15-AT

Enrollment

Registered

2007-07-04

Start date

2007-08-17

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

The objective of the present study is to investigate whether a combination of ultra-low-dose amitriptyline with the conventional local anesthetic lidocaine enhances the anesthetic effect of the latter via pharmacologic synergy. MedDRA version: 8.1 Level: LLT Classification code 10002095 Term: Anaesthesia local

Interventions

Trade Name: Xylanest Product Name: Xylanaest Pharmaceutical Form: Suspension for injection Trade Name: Redomex Product Name: Redomex Pharmaceutical Form: Injection*

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients undergoing elective placement of Cimino shunt in local anesthesia 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Contraindication to local anesthesia, non-compliance of patient, Pregnancy.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether an ultra-low dose of amitriptyline can enhance the local anesthetic properties of the conventional local anesthetic lidocaine. ;Secondary Objective: ;Primary end point(s): Time-course of Visual analogue scale during and after surgery.	—

Countries

Austria

Outcome results

None listed

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