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Chronic Pain Management After Herniorraphy (pregabalin)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00772291
First Posted: October 15, 2008
Last Update Posted: August 19, 2011
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.
Information provided by (Responsible Party):
hasan eker, Erasmus Medical Center
  Purpose
Nowadays, chronic pain mainly as a result of iatrogenic nerve damage is generally considered as the most frequent complication after inguinal hernia surgery. The primary objective of this randomised double-blind placebo-controlled trial is to investigate whether pregabalin reduces pain in patients with chronic pain of neuropathic origin after herniorraphy.

Condition Intervention Phase
Chronic Pain Drug: pregabalin Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chronic Pain Management After Herniorraphy:Pregabalin vs Placebo. A Double-blinded Randomised Controlled Clinical Trial.

Resource links provided by NLM:


Further study details as provided by hasan eker, Erasmus Medical Center:

Primary Outcome Measures:
  • pain [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • quantitative sensory testing (QST) accuracy in testing the inguinal region [ Time Frame: 8 weeks ]

Estimated Enrollment: 140
Study Start Date: May 2007
Study Completion Date: October 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Drug: placebo
placebo drug during 8 weeks
Active Comparator: pregabalin Drug: pregabalin
pregabalin 150-600mg/day during 8 weeks

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. History of unilateral inguinal herniotomy
  2. Establishment of neuropathic character of chronic pain by means the LANSS painscore and DN4 score
  3. Abnormal sensitivity (allodynia, dysesthesia, hypoesthesia or dysesthesia) in or around the incisional area
  4. Duration pain ≥ 3 months
  5. Medial or lateral inguinal hernia
  6. Age ≥ 18 years
  7. VAS score ≥ 40 mm on Vas scale on which they indicate 'how unpleasant or disturbing the worst pain was that they had today'
  8. Grade III or IV pain and discomfort on the 4-point pain and discomfort scale
  9. Informed consent (addendum V)

Exclusion Criteria:

  1. Participation in another trial
  2. Age < 18 years
  3. Cognitive disfunction
  4. Patient is unable to speak Dutch
  5. Hereditary problems of galactose intolerance, Lapp lactase deficiency or glucosegalactose malabsorption
  6. Patient classified as American Society of Anaesthesiologist Class 4
  7. Renal impairment
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00772291


Locations
Netherlands
Erasmus Medical Center
Rotterdam, Netherlands, 3015CE
Sponsors and Collaborators
Erasmus Medical Center
Investigators
Principal Investigator: J.F. Lange, professor Erasmus Medical Center
  More Information

Responsible Party: hasan eker, Prof. Dr. J.F. Lange, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT00772291     History of Changes
Other Study ID Numbers: pregabalin RCT
First Submitted: October 13, 2008
First Posted: October 15, 2008
Last Update Posted: August 19, 2011
Last Verified: August 2011

Keywords provided by hasan eker, Erasmus Medical Center:
inguinal
hernia
chronic
pain
pregabalin
chronic pain after inguinal herniorraphy

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs