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Chronic Pain Management After Herniorraphy (pregabalin)

Primary Purpose

Chronic Pain

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
pregabalin
placebo
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring inguinal, hernia, chronic, pain, pregabalin, chronic pain after inguinal herniorraphy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Erasmus Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo

pregabalin

Arm Description

Outcomes

Primary Outcome Measures

pain

Secondary Outcome Measures

quantitative sensory testing (QST) accuracy in testing the inguinal region

Full Information

First Posted
October 13, 2008
Last Updated
August 18, 2011
Sponsor
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00772291
Brief Title
Chronic Pain Management After Herniorraphy
Acronym
pregabalin
Official Title
Chronic Pain Management After Herniorraphy:Pregabalin vs Placebo. A Double-blinded Randomised Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
inguinal, hernia, chronic, pain, pregabalin, chronic pain after inguinal herniorraphy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
pregabalin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
pregabalin
Intervention Description
pregabalin 150-600mg/day during 8 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo drug during 8 weeks
Primary Outcome Measure Information:
Title
pain
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
quantitative sensory testing (QST) accuracy in testing the inguinal region
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of unilateral inguinal herniotomy Establishment of neuropathic character of chronic pain by means the LANSS painscore and DN4 score Abnormal sensitivity (allodynia, dysesthesia, hypoesthesia or dysesthesia) in or around the incisional area Duration pain ≥ 3 months Medial or lateral inguinal hernia Age ≥ 18 years VAS score ≥ 40 mm on Vas scale on which they indicate 'how unpleasant or disturbing the worst pain was that they had today' Grade III or IV pain and discomfort on the 4-point pain and discomfort scale Informed consent (addendum V) Exclusion Criteria: Participation in another trial Age < 18 years Cognitive disfunction Patient is unable to speak Dutch Hereditary problems of galactose intolerance, Lapp lactase deficiency or glucosegalactose malabsorption Patient classified as American Society of Anaesthesiologist Class 4 Renal impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J.F. Lange, professor
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3015CE
Country
Netherlands

12. IPD Sharing Statement

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Chronic Pain Management After Herniorraphy

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