Gabapentin in Phantom and Stump Pain

Phase 4

Completed

• Conditions: Amputation of Lower Limb

• Registration Number: NCT00169013
• Lead Sponsor: Danish Pain Research Center

Brief Summary

To investigate whether gabapentin can prevent phantom and stump pain after amputation.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-05
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Study Completion: 2006-06
• Status Verified: 2007-04
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Amputation of crus or femur

Exclusion Criteria

1. Patients who cannot cooperate
2. Fertile women without sufficient contraceptives
3. Allergy to gabapentin
4. Earlier amputation of the same limb except toes
5. Serious lever, kidney, cardiac, respiratory, haematological disease.-

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary outcome measures:
Number of patients with phantom and stump pain 30 days and 6 months after amputation
Average intensity of stump and phantom pain 30 days and 6 months after amputation

Secondary Outcome Measures

Name	Time	Method
McGill Pain Questionnaire day 7, 14 and 30, and 3 and 6 months
Prevalence and severity of phantom and stump pain at controls day 7, 14 and 30, and 3 and 6 months
Concurrent pain medication at day 7, 14 and 30, and 3 and 6 months
Brush evoked allodynia, wind up like pain to repetitive pinprick, pressure pain threshold at day 14 and 30.
Secondary outcome measures:

Trial Locations

Locations (1)

Danish Pain Research Center, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark