Ultrasound-guided Nerve Blocks for the Sciatic and Saphenous Nerves: Characteristics of the Single Penetration Dual Injection (SPEDI) Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Performance time (seconds and minutes). Time measurement from the time the ultrasound transducer is placed on the skin and until the needle is taken out of the body.
研究概览
简要总结
Background and aims: Ultrasound-guided (USG) nerve blocks of the sciatic nerve (popliteal level = PL) and the saphenous nerve (mid-femoral level = MFL) provides analgesia following leg surgery. Traditionally two separate injections are performed. The aim was to describe a novel, faster USG block combination requiring only one skin penetration to block the sciatic and saphenous nerves; i.e. the SPEDI block = Single PEnetration Dual Injection.
Methods: A randomized, controlled and double-blinded trial. Following ethics committee approval 60 patients will be randomized to the administration of an USG SPEDI block compared to two separate USG blocks of the saphenous (MFL) and sciatic (PL) nerves. Blocks will be performed after induction of general anaesthesia. Outcome measures will be performance time (primary outcome measure), Post-Anaesthesia Care Unit pain scores (VAS scores 0-10), block difficulty level (easy, middle, difficult), opioid consumption (in the PACU), serum-ropivacaine pharmacokinetics (blood sample 0-180 minutes). Both block combinations will be evaluated by MR imaging (MRI).
Hypothesis: The USG SPEDI block combination is expected to be performed significantly faster without moving the leg, and achieve successful perioperative pain management. The SPEDI block may find important use in the emergency setting.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •lower leg surgery
- •American Society of Anesthesiologist (ASA) score I-III
- •Can cooperate in the study
- •Speaks and understand the Danish language
- •General anesthesia
排除标准
- •Intake of oral morphine above 40 mg per day
- •Know allergy to ropivacaine
- •Abuse of alcohol or other substance abuse
- •Neuropathy
- •Nerve block contraindicated
结局指标
主要结局
Performance time (seconds and minutes). Time measurement from the time the ultrasound transducer is placed on the skin and until the needle is taken out of the body.
时间窗: The measurement (seconds and minutes) will take place in the operating room. This will normally be within a time frame of 1 minute to 10 minutes.
The time measurement is done with a normal clock - measuring seconds and minutes.
次要结局
- Pain score (VAS score 0-10).(When the patient are evaluated in the recovery unit upon arrival and when the patient is discharged from the recovery unit. This means from time 0 hours (arrival in the PACU) and normally until 2 hours after arrival in the PACU.)
- Sensory dermatome testing.(Normally until 2 hours postoperatively.)
研究者
Jens Borglum Neimann
Consultant anesthetist, PhD, Ass. Professor
Bispebjerg Hospital