Chronic Pain Management After Herniorraphy - Full Text View

Sponsor:	Erasmus Medical Center
Information provided by (Responsible Party):	hasan eker, Erasmus Medical Center
ClinicalTrials.gov Identifier:	NCT00772291

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 III

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:

MedlinePlus related topics: Hernia

Drug Information available for: Pregabalin

U.S. FDA Resources

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:

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

Contacts and Locations

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:

Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on February 09, 2012