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Chronic Pain Management After Herniorraphy

Information source: Erasmus Medical Center
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Pain

Intervention: pregabalin (Drug); placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Erasmus Medical Center

Official(s) and/or principal investigator(s):
J.F. Lange, professor, Principal Investigator, Affiliation: Erasmus Medical Center

Overall contact:
J.J. Harlaar, Msc, Phone: +31107043683, Email: j.harlaar@erasmusmc.nl

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.

Clinical Details

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

Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: pain

Secondary outcome: quantitative sensory testing (QST) accuracy in testing the inguinal region

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

J.J. Harlaar, Msc, Phone: +31107043683, Email: j.harlaar@erasmusmc.nl

Erasmus Medical Center, Rotterdam 3015CE, Netherlands; Recruiting
J.J. Harlaar, Msc, Phone: +31107043683, Email: j.harlaar@erasmusmc.nl
H.H. Eker, MD, Phone: +31107034519, Email: h.eker@erasmusmc.nl
J.F. Lange, professor, Principal Investigator
F. Huygen, PhD, Principal Investigator
Additional Information

Starting date: May 2007
Last updated: August 10, 2009

Page last updated: October 04, 2010

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