The effect of pregabalin in the treatment of acute post-operative peripheral neuropathic pain – a pilot study

Phase 1

• Conditions: acute post-operative peripheral neuropathic pain; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-004417-40-NO
• Lead Sponsor: Helse Bergen HF

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-29
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Age:
Participant must be 18 years of age inclusive, at the time of signing the informed consent.
Type of Participant and Disease Characteristics:
Patients that have verified NeP following surgery and are identified and included within 7 days after nerve injury

Informed Consent:
Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

Medical Conditions:
1.Psychiatric disease
2.Renal failure (GFR <60)
3.Patients that are cognitively impaired
4.Daily substance abuse (drugs/alchohol)
5.Pregnancy

Prior/Concomitant Therapy:
1.Patients that use current 1st line NeP-medication at admission, regardless of indication. This includes Lyrica, gabapentin, SNRI and Tricyclic antidepressiva.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified