Laparoscopic Combined Hypo Gastric Neural Plexus Block and Uterosacral Nerve Block for Patients With Chronic Idiopathic Pelvic Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual analogue score
研究概览
简要总结
Often the etiology of chronic pelvic pain is not clear, as there are many disorders of the reproductive tract, gastrointestinal system, urological organs, musculoskeletal system, and psych neurological system that may be associated with chronic pelvic pain.
An effective treatment for this condition has evaded the medical profession for centuries. Even today only 20-25% patients respond to conservative management.5 When such treatment fails, a diagnostic laparoscopy is performed.1, 3, 6 the cause of the pain is not always obvious as no pathology is seen in 40-60% of the cases.1
详细描述
This prospective randomized controlled study will be conducted at Eldemerdash hospital. 60 patients will be included with the following criteria:
. Intraoperatively, all patients were monitored by standard monitoring.
All Patients will be assigned randomly by using computerized program to one of the two equal groups. Patients will be (thirty patients per group):
Group A ; thirty patients will do laparoscopy for diagnosis of the causes of chronic pelvic pain then injecting 5 ml normal saline for hydro dissection of the retroperitoneal space at the level of the sacral promontory then30 ml (14 ml Marcaine +14 ml normal saline+2ml betamethasone) are injected.
Group B; thirty patients will do laparoscopy for diagnosis and conventional surgical treatment of the causes of pelvic pain then injecting 5 ml normal saline for hydro dissection of the retroperitoneal space at the level of the promontory followed by 30 ml (14 ml Marcaine +14 ml normal saline+2ml betamethasone) then injecting 5 ml ( 2.5 marcaine+1ml betamethasone +1.5 ml normal saline) 2 cm away from the cervix at the uterosacral ligament on each sides.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Age 18 to 50 years old.
- •American Society of Anesthesiologists physical status (ASA-PS) I and II Patients.
- •Sex: female.
- •Patients scheduled for elective laparoscopy for diagnosis of the cause of chronic pelvic pain.
排除标准
- •• Patient refusal.
- •Patients on chronic pain medications.
- •ASA III or worse clinical condition.
- •Intra-abdominal infection.
- •Allergy to any of the study medications.
研究组 & 干预措施
Laparoscopic Hypo gastric Neural Plexus Block
laparoscopy for diagnosis of the causes of chronic pelvic pain then injecting 5 ml normal saline for hydro dissection of the retroperitoneal space at the level of the sacral promontory then30 ml (14 ml Marcaine +14 ml normal saline+2ml betamethasone) are injected.
干预措施: MARCAINE AND BETAMETHAZONE 1 (Drug)
Laparoscopic Combined Hypo gastric Neural Plexus Block and Uterosacral Nerve Block
laparoscopy for diagnosis and conventional surgical treatment of the causes of pelvic pain then injecting 5 ml normal saline for hydro dissection of the retroperitoneal space at the level of the promontory followed by 30 ml (14 ml Marcaine +14 ml normal saline+2ml betamethasone) then injecting 5 ml ( 2.5 marcaine+1ml betamethasone +1.5 ml normal saline) 2 cm away from the cervix at the uterosacral ligament on each sides.
干预措施: MARCAINE AND BETAMETHAZONE 2 (Drug)
结局指标
主要结局
Visual analogue score
时间窗: 16th week after laparoscopy
Visual analogue scale: No pain Moderate Worst Pain 0 1 2 3 4 5 6 7 8 9 10
次要结局
- constipation(number of patients)(up to 16 weeks postoperatively)
- duration of pain relieve(up to 16 weeks postoperatively)
- urinary retention (number of patients)(up to 16 weeks postoperatively)
- Duration of pelvic pain relieve(up to 16 weeks postoperatively)
研究者
RAMY AHMED
ASSITANT PROFESSOR
Ain Shams University