Chronic Pain Management After Herniorraphy

NCT ID: NCT00772291

Last Updated: 2011-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo drug during 8 weeks

pregabalin

Group Type ACTIVE_COMPARATOR

pregabalin

Intervention Type DRUG

pregabalin 150-600mg/day during 8 weeks

Interventions

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pregabalin

pregabalin 150-600mg/day during 8 weeks

Intervention Type DRUG

placebo

placebo drug during 8 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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hasan eker

Prof. Dr. J.F. Lange

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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J.F. Lange, professor

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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Erasmus Medical Center

Rotterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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pregabalin RCT

Identifier Type: -

Identifier Source: org_study_id

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