Influence of General and Local Anesthesia on Postoperative Pain After Loop Electrosurgical Excision Procedure: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 248
- 试验地点
- 2
- 主要终点
- visual analog scale 1
研究概览
简要总结
The loop electrosurgical excision procedure (LEEP) is a modified cervical conization that is performed with an electrosurgical loop. It may be performed under local anesthesia (LA) or under general anesthesia (GA), and practice patterns differ widely. In some countries, specific guidelines for the choice of anesthesia during LEEP are provided, whereas, in other countries, the choice of anesthesia is not specified. LEEP under LA is more economical, obviating the need for anesthesia staff, equipment, and operating room fees. However, LEEP under LA may be more difficult to perform, may be more difficult to learn, may lead to inferior surgical results, and may result in more pain and patient dissatisfaction. This study aimed to compare loop electrosurgical excision procedures under local anesthesia vs general anesthesia regarding patients' satisfaction, histopathologic results, and short-term morbidity
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients were > 21 years old; were not pregnant
- •The patient had one of the following indications for LEEP:
- •histologyproven, persistent, low-grade squamous intraepithelial lesion (LGSIL);
- •a histology-proven high-grade squamous intraepithelial lesion (HGSIL);
- •discrepancies between cytological reports and colposcopic impressions;
- •investigation for unsatisfactory colposcopy;
- •microinvasion or adenocarcinoma in situ on cervical punch biopsy.
排除标准
- •Patients with cervical or vaginal infection; Patients with an abnormal menstrual cycle; who were taking anticoagulants, Patients with a coagulation defect Patients with mental incapacity Patients with previous hysterectomy with removal of the cervix Patients with a history of cervical cancer.
研究组 & 干预措施
Control
GA group intravenous 2-3 μ/kg fentanyl followed by 2 mg/kg propofol. were administered for anesthesia induction. After a laryngeal mask insertion anesthesia was maintained by inhalation of sevoflurane in an oxygen (60%) and nitrous oxide (40%) mixture to maintain a minimal alveolar concentration (MAC) of 0.8%-1.3%.
干预措施: LEEP (Procedure)
Study
In the LA group, after positioning of the patient, 50 mg of lidocaine spray (5 pumps, 10 mg in each pump) were applied to the ectocervix, then 2 mL bupivacaine hydrochloride was injected submucosally using a 27-gauge needle tip at the 3, 6, 9, and 12 o'clock locations in the ectocervix.
干预措施: LEEP (Procedure)
结局指标
主要结局
visual analog scale 1
时间窗: up to 1 hour after the procedure
VAS score ( 0 cm = no pain, 10 cm = worst pain imaginable) reported for the pain felt at 1 hour after procedure.
次要结局
- visual analog scale 2(up to 2 hour after the procedure)
研究者
Kemal GUNGORDUK
Medical Doctor - Professor
Erzincan Military Hospital