Oral Gabapentin in Management of Chronic Pelvic Pain in Females: A Randomised Placebo-controlled Study.

Study Overview
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Brief Summary
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Aim :The aim of this study is to evaluate the efficacy of oral Gabapentin in the treatment of chronic pelvic pain in females. The study is designed as a randomised, placebo-controlled, clinical trial.32 patients will be enrolled each arm. Group A (cases): This group will include (32) women according to inclusion and exclusion criteria and will receive a card of Gabapentin which will be taken orally by the patient at home three times daily and maximum dose 2700mg per day by 300 mg increments each week until sufficient pain relief, or the occurrence of side effects such as dizziness, somnolence, edema and ataxia. Group B (controls):This group will include (32) women . Assessment of the patient's pain during the physical examination will be done using the Visual Analogue Scale (VAS). The patient will be asked to place a mark on a drawn 10 cm line at a point which is corresponding to the intensity of her pain. One end of the line denotes no pain and the other end of the line indicates that pain is as bad as it can be (the worst pain).the distance in cm from the low end of VAS to the patient's mark will be used (it gives a number.Questionnaire: will be given to all participants at randomization (0 months) , at 3 months and at 6 months to assess the degree of pain improvement via VAS. Patients' overall satisfaction with their pain treatment &Side effect recording (e.g., dizziness, somnolence, mood changes, appetite and poor concentration).

Official Title
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Oral Gabapentin in Management of Chronic Pelvic Pain in Females: A Randomised Placebo-controlled Study.

Conditions
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Pelvic Pain

Intervention / Treatment
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* Drug: Gabapentin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate to severe chronic pelvic pain for at least 6 months. Pain was unrelated exclusively to menstruation. Pain incompletely relieved by Non-steroidal Ant-inflammatory drugs. Patients had regular menstrual cycles for 3 months. Patient receiving regular, effective contraceptive method. Exclusion Criteria: Pregnancy or planning of pregnancy in next 6 months. Breast feeding. Acute pelvic infection. Known history of hypersensitivity to Gabapentin. Patients with severe renal or hepatic failure. Women with previous diagnosis of endometriosis confirmed by laparoscopy. Women with previous diagnosis of Malignancy. Plans for surgery in next 6 months. Women with chronic or recurrent gastrointestinal disease, including irritable bowel syndrome. Women with histories of alcohol use or other chronic tranquilizers. Patients refuse to sign an informed consent form.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gabapentin<br>This group will include (32) women according to inclusion and exclusion criteria and will receive a card of Gabapentin which will be taken orally by the patient at home three times daily and maximum dose 2700mg per day by 300 mg increments each week until sufficient pain relief, or the occurrence of side effects such as dizziness, somnolence, edema and ataxia. | Drug: Gabapentin<br>* This group will include (32) women according to inclusion and exclusion criteria and will receive a card of Gabapentin which will be taken orally by the patient at home three times daily and maximum dose 2700mg per day by 300 mg increments each week until sufficient pain relief, or the occurrence of side effects such as dizziness, somnolence, edema and ataxia.<br>|
| Placebo Comparator: Placebo<br>Group B (controls):This group will include (32) women according to inclusion and exclusion criteria and will receive a card of placebo. | Other: Placebo<br>* Group B (controls):This group will include (32) women according to inclusion and exclusion criteria and will receive a card of placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score improvement |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effect recording |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gabapentin, chronic pelvic pain.