Chronic Pain Management After Herniorraphy

Chronic Pain Clinical Trial

— pregabalin  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772291
• Other study ID #: pregabalin RCT
• Status: Completed
• Phase: Phase 3
• First received: October 13, 2008
• Last updated: August 18, 2011
• Start date: May 2007
• Est. completion date: October 2010

Study information

• Verified date: August 2011
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: October 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• pregabalin
pregabalin 150-600mg/day during 8 weeks
• placebo
placebo drug during 8 weeks

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain		8 weeks	No
Secondary	quantitative sensory testing (QST) accuracy in testing the inguinal region		8 weeks	No