Clinical trial NCT02918760: Oral Gabapentin in Management of Chronic Pelvic Pain in Females: A Randomised Placebo-controlled Study.
Official title: Oral Gabapentin in Management of Chronic Pelvic Pain in Females: A Randomised Placebo-controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pelvic Pain
Keywords: Gabapentin, chronic pelvic pain.
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-09-29
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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.

Primary outcomes:
measure: Pain score improvement
timeFrame: 6 months
Secondary outcomes:
measure: Side effect recording
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Mohamed Abdel hafeez, A.professor
role: STUDY_CHAIR
References:
citation: AbdelHafeez MA, Reda A, Elnaggar A, El-Zeneiny H, Mokhles JM. Gabapentin for the management of chronic pelvic pain in women. Arch Gynecol Obstet. 2019 Nov;300(5):1271-1277. doi: 10.1007/s00404-019-05272-z. Epub 2019 Aug 21.