NCT01603680已完成4 期
Circumferential Versus Not Circumferential Distribution of Mepivacaine Around the Median and Ulnar Nerves in the Carpal Tunnel Surgery. Randomized Clinical Trial, Double Blinded.
Complexo Hospitalario Universitario de A Coruña2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2012年1月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Efficacy and onset of action
研究概览
简要总结
- Evaluation of the efficacy of the circumferential versus non circumferential distribution of mepivacaine around the median and ulnar nerves.
- Evaluation the onset of action of mepivacaine in circumferential versus non circumferential distribution around the median and ulnar nerves.
- Spread of mepivacaine after injection guided by ultrasonography.
- Complications of both anesthetic techniques in postoperative time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled patients for surgery of carpal tunnel including patients in ASA I-III status, without
排除标准
- •. The principal investigator study and/or other designated site staff will obtain written informed consent from all research patients.
- •Exclusion Criteria:
- •Abnormal bleeding, infection in the punction side, allergy or other problems with the medication of the study, muscular or nerve diseases, patients < 18 years old, pregnancy, cognitive disease or reject of the patient
结局指标
主要结局
Efficacy and onset of action
时间窗: On arrival in the recovery room
Sensory block will be assessed as a loss of cold sensation elicited by a cold wet cotton swab in the areas of the medial and ulnar nerves by comparison with contralateral hand. Sensory block will be clasiffied as follows: 0, anesthesia; 1, hyposthesia; 2, normal sensation. Motor function will be tested as according to a modified Bromage score: 0, no motor blokade; 1, weak response against resistence; 2, complete motor blockade. Motor and sensory blockades will be assessed by a blinded observer at 5, 15, 30 mins after local anesthetic injection and on arrival in the recovery room.
次要结局
- Complications in postoperative time(24 hours postoperative time)
研究者
Paula Diéguez García
Principal Investigator
Complexo Hospitalario Universitario de A Coruña
研究点 (2)
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