Administration of Local Anesthetic in Trigger Thumb Surgery: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Difference in administered anesthesia
研究概览
简要总结
We are conducting this study to determine if administration of local anesthetic to the thumb prior to surgery can reduce the amount of anesthetic gas given during the course of surgery.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Years 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, age 0-4 years, presenting to the Children's Hospital of Philadelphia (CHOP) Department of Orthopaedics with unilateral trigger thumb that requires surgical treatment.
- •American Society of Anaesthesiologists (ASA) Classification of 1 or
- •Parental/guardian permission (informed consent).
排除标准
- •Males or females over the age of
- •ASA Classification higher than
- •Patients presenting with systemic diseases or significant comorbidities.
- •Patients that received treatment for trigger thumb at an outside institution.
研究组 & 干预措施
Intervention Arm
Participants randomized into the intervention group will receive an injection of 2.5 cc of 0.25% marcaine without epinephrine prior to the incision. The local anesthetic will be administered by the treating surgeon. All other aspects of the procedure will be kept in accordance with the standard of care for trigger thumb surgeries.
干预措施: Administration of Marcaine without Epinephrine prior to the start of surgery (Procedure)
Non-Intervention Arm
Those that are not randomized into the intervention group will receive the standard of care for a trigger thumb release, which is administration of 2.5 cc of 0.25% marcaine without epinephrine following completion of surgery. The local anesthetic will be administered by the treating surgeon.
结局指标
主要结局
Difference in administered anesthesia
时间窗: 3 years
The primary outcome will be the difference in administered gaseous sevoflurane during the course of trigger thumb surgery between the control group and intervention group.
次要结局
- Difference in observed pain score(3 years)
- Difference in operative time(3 years)
- Difference in length of stay(3 years)
- Difference in complication rates(3 years)