CHRONIC PAIN MANAGEMENT AFTER HERNIORRAPHY PREGABALIN VERSUS PLACEBO

Phase 4

Completed

• Conditions: groin pain; Inguinodynia; 10034606

• Registration Number: NL-OMON30188
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 135

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. Gender: Male
6. Medial or lateral inguinal hernia
7. Age >= 18 years
8. Description III or IV of pain interfering with daily activity
9. VAS score >= 40 mm on Vas scale on which they indicate *how unpleasant or disturbing the worst pain was that they had today*
10. Informed consent (addendum V)

Exclusion Criteria

1. Participation in another trial
2. Bilateral hernia
3. Recurrent hernia
4. Age < 18 years
5. Cognitive disfunction
6. Patient is unable to speak Dutch
7. Description I or II of pain interfering with daily activity
8. Patient classified as American Society of Anaesthesiologist Class 4

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the mean 11-point numerical pain rating score in both<br /><br>treatment groups at baseline and follow-up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcomes are the mean light-touch and thermal QST thresholds<br /><br>between the painful inguinal area and the normal contra-lateral side in<br /><br>patients from both treatment groups at baseline and follow-up.</p><br>