Chronic Pain Management After Herniorraphy

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00772291

Acronym

pregabalin

Enrollment

140

Registered

2008-10-15

Start date

2007-05-31

Completion date

2010-10-31

Last updated

2011-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

inguinal, hernia, chronic, pain, pregabalin, chronic pain after inguinal herniorraphy

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.

Interventions

DRUGpregabalin

pregabalin 150-600mg/day during 8 weeks

DRUGplacebo

placebo drug during 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
pain	8 weeks

Secondary

Measure	Time frame
quantitative sensory testing (QST) accuracy in testing the inguinal region	8 weeks

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026