Pelvic Pain Clinical Trial
Official title:
Oral Gabapentin in Management of Chronic Pelvic Pain in Females: A Randomised Placebo-controlled Study.
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).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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