Chronic Pain Management After Herniorraphy (pregabalin)

Erasmus University

Status and phase: Completed; Phase 3

Conditions: Chronic Pain

Treatments: Drug: pregabalin; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00772291

pregabalin RCT

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Treatment:

Drug: placebo

pregabalin

Active Comparator group

Treatment:

Drug: pregabalin