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OpenTrials
Completed

NCT Number: NCT00772291

Chronic Pain Management After Herniorraphy

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.

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Key information

Conditions

Chronic Pain Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Hernia Immune System Diseases Lung Diseases Lung Diseases, Obstructive Neurologic Manifestations Organizing Pneumonia Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Erasmus Medical Center

Rotterdam, 3015CE, Netherlands

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Participation in another trial
  • Age < 18 years
  • Cognitive disfunction
  • Patient is unable to speak Dutch
  • Hereditary problems of galactose intolerance, Lapp lactase deficiency or glucosegalactose malabsorption
  • Patient classified as American Society of Anaesthesiologist Class 4
  • Renal impairment

Treatment and study plan

Pregabalin

Drug

pregabalin 150-600mg/day during 8 weeks

Placebo

Drug

placebo drug during 8 weeks

Primary outcomes

  1. pain

    Time frame: 8 weeks

Secondary outcomes

  1. quantitative sensory testing (QST) accuracy in testing the inguinal region

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

Chronic Pain Management After Herniorraphy:Pregabalin vs Placebo. A Double-blinded Randomised Controlled Clinical Trial.

Acronym: pregabalin

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Oct 15, 2008
Registry last updated
Aug 19, 2011

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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