Sacrococcygeal Local Anesthesia With Different Doses of Clonidine for Pilonidal Sinus Surgery: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Compare analgesic consumption using questionnaire
研究概览
简要总结
Sacrococcygeal local anesthesia was shown to reduce the time spent in the operating room as well as in the recovery room. In addition, decreased hospital stay and postoperative analgesic consumption.
Given the effectiveness of sacrococcygeal local anesthesia in pilonidal sinus surgery, it would be valuable to study the effect of the local anesthesia with 75µg/mL of clonidine versus 150µg/mL.
详细描述
Study design and sampling
This is a prospective study with a randomized double-blind design that will be conducted between October 2015 and October 2016.
Patients scheduled for pilonidal sinus surgery will be included. Patients will be randomly distributed to one of 2 groups with 30 patients in each, using the sealed envelope technique. Group one will receive sacrococcygeal local anesthesia with 75µg/mL of clonidine, while group two will receive sacrococcygeal local anesthesia with 150µg/mL of clonidine.
Anesthetic techniques
Being a double-blinded study, a specialized nurse will prepare the syringes for each patient.
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
- •Patients scheduled for pilonidal sinus surgery
排除标准
- •Patients who have allergic reactions to lidocaine
研究组 & 干预措施
Clonidine 75
Patients will receive sacrococcygeal local anesthesia with 75µg/mL of clonidine. The anesthetic mixture will contain: lidocaine 2% 14 mL, bupivacaine 0.5% 5 mL, and clonidine 0.5 mL with 0.5 mL of saline (thus 75 µg/mL).
干预措施: Clonidine 75 µg/mL in sacrococcygeal block (Drug)
Clonidine 75
Patients will receive sacrococcygeal local anesthesia with 75µg/mL of clonidine. The anesthetic mixture will contain: lidocaine 2% 14 mL, bupivacaine 0.5% 5 mL, and clonidine 0.5 mL with 0.5 mL of saline (thus 75 µg/mL).
干预措施: Lidocaine (Drug)
Clonidine 75
Patients will receive sacrococcygeal local anesthesia with 75µg/mL of clonidine. The anesthetic mixture will contain: lidocaine 2% 14 mL, bupivacaine 0.5% 5 mL, and clonidine 0.5 mL with 0.5 mL of saline (thus 75 µg/mL).
干预措施: Pilonidal sinus (Procedure)
Clonidine 150
Patients will receive sacrococcygeal local anesthesia with 150µg/mL of clonidine. The anesthetic mixture will contain: lidocaine 2% 14 mL, bupivacaine 0.5% 5 mL, and clonidine 1 mL (thus 150 µg/mL).
干预措施: Clonidine 150 µg/mL in sacrococcygeal block (Drug)
Clonidine 150
Patients will receive sacrococcygeal local anesthesia with 150µg/mL of clonidine. The anesthetic mixture will contain: lidocaine 2% 14 mL, bupivacaine 0.5% 5 mL, and clonidine 1 mL (thus 150 µg/mL).
干预措施: Lidocaine (Drug)
Clonidine 150
Patients will receive sacrococcygeal local anesthesia with 150µg/mL of clonidine. The anesthetic mixture will contain: lidocaine 2% 14 mL, bupivacaine 0.5% 5 mL, and clonidine 1 mL (thus 150 µg/mL).
干预措施: Pilonidal sinus (Procedure)
结局指标
主要结局
Compare analgesic consumption using questionnaire
时间窗: Patients will be followed-up after the operation, an expected average of five days
次要结局
- Time needed to return to normal activity noted by calling the patients(Patients will be followed-up after the operation, an expected average of five days)
- Pain using verbal numeric rating scale (VNRS)(Patients will be followed-up after the operation, an expected average of five days)
研究者
Zoher Naja
Chairperson of Anesthesia and Pain Management Department
Makassed General Hospital