Gabapentin in Phantom and Stump Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00169013
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : April 12, 2007
Information provided by:
Danish Pain Research Center

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

Condition or disease Intervention/treatment Phase
Amputation of Lower Limb Drug: Gabapentin Phase 4

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Gabapentin in the Prevention of Phantom Limb Pain
Study Start Date : May 2002
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.-

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00169013

Danish Pain Research Center, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
Danish Pain Research Center
Principal Investigator: Lone Nikolajsen, MD, PhD Danish Pain Research Center

Additional Information: Identifier: NCT00169013     History of Changes
Other Study ID Numbers: Gabapentin2002
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: April 12, 2007
Last Verified: April 2007

Additional relevant MeSH terms:
gamma-Aminobutyric Acid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents