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

Only registered users can translate articles

The link is saved to the clipboard

Status

Keywords

Abstract

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).

Dates

Last Verified:	08/31/2016
First Submitted:	09/26/2016
Estimated Enrollment Submitted:	09/26/2016
First Posted:	09/28/2016
Last Update Submitted:	09/26/2016
Last Update Posted:	09/28/2016
Actual Study Start Date:	02/29/2016
Estimated Primary Completion Date:	11/30/2016

Condition or disease

Pelvic Pain

Intervention/treatment

Drug: Gabapentin

Other: Placebo

Phase

Phase 3

Arm Groups

Arm	Intervention/treatment
Experimental: Gabapentin 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 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.
Placebo Comparator: Placebo Group B (controls):This group will include (32) women according to inclusion and exclusion criteria and will receive a card of placebo.	Other: Placebo Group B (controls):This group will include (32) women according to inclusion and exclusion criteria and will receive a card of placebo.

Eligibility Criteria

Ages Eligible for Study	18 Years To 18 Years
Sexes Eligible for Study	Female
Accepts Healthy Volunteers	Yes
Criteria	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.

Outcome

Primary Outcome Measures

1. Pain score improvement [6 months]

Secondary Outcome Measures

1. Side effect recording [6 months]

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

Keywords

pelvic pain

dizziness

sleepiness

edema

ataxia