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OpenTrials
Completed

NCT Number: NCT00169013

Gabapentin in Phantom and Stump Pain

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

Completed

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Key information

Conditions

Amputation of Lower Limb

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Danish Pain Research Center, Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Amputation of crus or femur

Exclusion criteria

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

Treatment and study plan

Gabapentin

Drug

Primary outcomes

  1. Primary outcome measures:

  2. Number of patients with phantom and stump pain 30 days and 6 months after amputation

  3. Average intensity of stump and phantom pain 30 days and 6 months after amputation

Secondary outcomes

  1. Secondary outcome measures:

  2. Prevalence and severity of phantom and stump pain at controls day 7, 14 and 30, and 3 and 6 months

  3. McGill Pain Questionnaire day 7, 14 and 30, and 3 and 6 months

  4. Concurrent pain medication at day 7, 14 and 30, and 3 and 6 months

  5. Brush evoked allodynia, wind up like pain to repetitive pinprick, pressure pain threshold at day 14 and 30.

Sponsors and collaborators

Lead sponsor

Danish Pain Research Center

Other

Collaborators

  • Pfizer

Registry information

Official study title

Gabapentin in the Prevention of Phantom Limb Pain

Important dates

Study start
2002
Study completion
2006
First posted
Sep 15, 2005
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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