pregabalin: Chronic Pain Management After Herniorraphy

Sponsor

Erasmus Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00772291

Collaborator

(none)

140

Enrollment

Location

Arms

Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Chronic Pain	Drug: pregabalin Drug: placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

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.

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Aug 1, 2010

Actual Study Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: placebo	Drug: placebo placebo drug during 8 weeks
Active Comparator: pregabalin	Drug: pregabalin pregabalin 150-600mg/day during 8 weeks

Arm

Intervention/Treatment

Placebo Comparator: placebo

Drug: placebo

placebo drug during 8 weeks

Active Comparator: pregabalin

Drug: pregabalin

pregabalin 150-600mg/day during 8 weeks

Outcome Measures

Primary Outcome Measures

pain [8 weeks]

Secondary Outcome Measures

quantitative sensory testing (QST) accuracy in testing the inguinal region [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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