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Trial record 51 of 135 for:    AMITRIPTYLINE

Treatment of Ilioinguinal Entrapment Syndrome - an Often Overlooked Cause of Chronic Pelvic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01020162
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : November 25, 2009
Information provided by:
Göteborg University

Brief Summary:
Neuralgic pain caused by entrapment of peripheral nerves is an often overlooked cause of chronic pelvic pain. The objective of the present study was to assess pain and quality of life in women with pain caused by entrapment of the ilioinguinal nerve, iatrogenic after surgery but also found without previous surgery. In a controlled prospective cross-over study 19 women were randomized either to medical treatment or to resection of the nerve. Statistically significant improvements were found after surgical resection.

Condition or disease Intervention/treatment Phase
Chronic Pelvic Pain Drug: Amitryptiline, gabapentin Procedure: Resection of the ilioinguinal nerve Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Ilioinguinal Entrapment Syndrome - a Randomised Controlled Trial
Study Start Date : September 1995
Actual Primary Completion Date : December 2006
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain

Arm Intervention/treatment
Active Comparator: Non-surgical
TENS, amitriptyline, gabapentin.
Drug: Amitryptiline, gabapentin
For amitryptiline starting dose 20-30 mg at night, increasing until clinical effect. For gabapentin was the initial dose 300 mg tid with rapid increases up to 800 mg tid.
Other Names:
  • Amitryptiline - Saroten
  • Gabapentin - Neurontin

Active Comparator: Surgical intervention
Resection of the ilioinguinal nerve
Procedure: Resection of the ilioinguinal nerve
In general anaesthesia the nerve was identified and resected as central as possible

Primary Outcome Measures :
  1. Improvements in pain according to Visual Analogue Scales. Improvements in quality of life according to Psychological General Well-Being-scales. [ Time Frame: At least one year after intervention,in some cases more then five years. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pelvic pain in which a careful investigation has shown signs of ilioinguinal nerve entrapment

Exclusion Criteria:

  • Drug abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01020162

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Dept Obstetrics&Gynecology/East Hospital
Gothenburg, Sweden, S-41685
Sponsors and Collaborators
Göteborg University
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Study Chair: Ian Milsom, MD,PhD Dept Obstetrics&Gynecology, Sahlgrenska Academy at the University of Gothenburg, Sweden

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Responsible Party: Lennart Hahn, MD PHD, Dept of Obstetrics&Gynecology, Sahlgrenska Academy at the University of Gothenburg Identifier: NCT01020162     History of Changes
Other Study ID Numbers: 429-05
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: November 25, 2009
Last Verified: November 2009
Keywords provided by Göteborg University:
Chronic pelvic pain
ilioinguinal nerve entrapment
randomized study
Chronic pelvic pain in women
Additional relevant MeSH terms:
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Amitriptyline, perphenazine drug combination
Pelvic Pain
Neurologic Manifestations
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Antidepressive Agents, Tricyclic
Antidepressive Agents
Analgesics, Non-Narcotic
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents
Antipsychotic Agents