A Comparison Between Scalp Nerve Block and Scalp Infiltration on the Circulatory and Stress Response for Aneurysm Clipping Using an Enhanced Recovery After Surgery Programme
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change of IL-10 in pg/ml
研究概览
简要总结
Forty ASA I or II patients, scheduled for aneurysm clipping were enrolled in this prospective, randomized, controlled study. Those patients were randomly divided into 3 groups: Group B (Scalp nerve block before skin incision n=15), Group I (Scalp infiltration before incision n=15), respectively with 0.75% of ropivacaine, and Group C (the control group, n=15). Opioids were used to control haemodynamic responses.All patients received the same general anesthesia.
After intubation, in group B, scalp block was performed by blocking the nerves that innervate the scalp, including the supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, greater occipital and lesser occipital nerves, and skin along the incision was infiltrated with 0.75% ropivacaine (group I, n = 15), respectively. For group C, there is no treatment. All patients received the same general anesthesia. The depth of anaesthesia was adjusted to maintain a BIS of 40-60. Characteristics of patients were recorded. Heart rate (HR) and mean arterial pressure (MAP) were recorded preoperatively, after induction, before skin incision, the moment of incision, after skin incision. Plasma levels of IL-6, IL-10, CRP were measured before surgery, skin incision,after the surgery. Postoperative pain scores (VAS) for 2, 4, 8, 12, 24, 48 hours after recovery of consciousness were also recorded. Postoperative complications ( nausea, vomiting, infection, and other adverse events) were monitored after surgery.
详细描述
For group B, the scalp block was performed bilaterally with 0.75% ropivacaine by the anesthesiologist. The supraorbital and supratrochlear nerves emerge from the orbit, and a needle was introduced above the eyebrow perpendicular to the skin with ropivacaine and was then gradually withdrawn with simultaneous injection of solutions throughout the entire. The zygomaticotemporal nerve emerge lateral to the orbit, equal to the position of pterion, this nerve was blocked with ropivacaine. The auriculotemporal nerve was blocked bilaterally anterior to the ear at the level of the tragus, the needle was introduced perpendicularly to the skin and infiltration was performed deep to the fascia and superficially as the needle was withdrawn. Care must be taken to avoid destroying superficial temporal artery. The greater, lesser, and third occipital nerves may be blocked using a needle, with infiltration along the superior nuchal line, approximately halfway between the occipital protuberance and the mastoid process.
For group I patients, neurosurgeons infiltrated the planned incision by a needle penetrated deeply to the skin with 0.75% ropivacaine throughout the entire thickness of the scalp.Neither scalp block nor local infiltration was performed in the control group (group C).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists physical status I or II
- •Glasgow coma score (GSC) of 15
- •Exclusion criteria:
- •ASA physical status of more than II
- •A ruptured cerebral aneurysm and subarachnoid haemorrhage
- •A history of allergy to opiates or any other drug used in the study
- •Impaired renal, hepatic, or pulmonary function
- •Allergic reaction to local anesthetics
排除标准
- 未提供
研究组 & 干预措施
Block
Scalp nerve block with 10ml solution of 0.75% ropivacaine before skin incision, n=15
干预措施: Scalp Nerve Block (Procedure)
Block
Scalp nerve block with 10ml solution of 0.75% ropivacaine before skin incision, n=15
干预措施: Ropivacaine (Drug)
Infiltration
Scalp infiltration with 10ml solution of 0.75% ropivacaine before incision, n=15
干预措施: Scalp infiltration (Procedure)
Infiltration
Scalp infiltration with 10ml solution of 0.75% ropivacaine before incision, n=15
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Change of IL-10 in pg/ml
时间窗: change from baseline IL-10 values at 24 hour hours after surgery
Change of plasma levels of IL-10
次要结局
- Postoperative VAS scores(2, 4, 8, 12, 24, 48 hours after recovery of consciousness)
- Mean Arterial Pressure in mmHg(baseline, 5 minutes after induction, 2 seconds after skin incision, 2 minutes and 5 minutes after the incision, 2 seconds after skull drilling)
- Heart Rate in bpm(baseline, 5 minutes after induction, 2 seconds after skin incision, 2 minutes and 5 minutes after the incision, 2 seconds after skull drilling)
- Change of IL-6 in pg/ml(change for baseline IL-6 values at 24 hour hours after surgery)
研究者
Xi Yang
Principal Investigator
Wuhan University