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Chronic Pain Management After Herniorraphy (pregabalin)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
hasan eker, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT00772291
First received: October 13, 2008
Last updated: August 18, 2011
Last verified: August 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Erasmus Medical Center:

Primary Outcome Measures:
  • pain [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quantitative sensory testing (QST) accuracy in testing the inguinal region [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 13, 2008
Last Updated: August 18, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Additional relevant MeSH terms:
Chronic Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Pregabalin
Analgesics
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014