Oral Gabapentin in Management of Chronic Pelvic Pain in Females: A Randomised Placebo-controlled Study.
试验速览
- 阶段
- 3 期
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Pain score improvement
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Gabapentin (Drug)
Placebo
Group B (controls):This group will include (32) women according to inclusion and exclusion criteria and will receive a card of placebo.
干预措施: Placebo (Other)
结局指标
主要结局
Pain score improvement
时间窗: 6 months
次要结局
- Side effect recording(6 months)
研究者
Dr.Ahmed Elnaggar
Lecturer
Ain Shams University