Echo-guided scalp blocks and incidence of postoperative pain in scheduled supratentorial intracranial surgery - ULTRASCALP
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Composite criterion of occurrence of events involving : - Either the need for morphine titration at a dosage greater than 0.05 mg.kg-1 in the immediate postoperative period (i.e., up to 6 h after extubation). - or the existence of severe pain defined by a numerical scale episode > 4 in the immediate post-operative period (i.e. up to 6 hours after extubation).
研究概览
简要总结
Demonstrate the efficacy of echo-guided scalp blocks in decreasing the incidence of severe pain in the early postoperative period of supratentorial intracranial surgeries.
入排标准
- 年龄范围
- 18 years 至 65+ years(18-64 Years, 65+ Years)
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Patient admitted to the neurosurgical unit for intracranial supratentorial surgery with flap performed
- •Person affiliated with or benefiting from a social security scheme
- •Free, informed and written consent signed by the participant and the investigating physician (no later than the day of inclusion and before any examination required by the research).
排除标准
- •Awake surgical procedure (systematic scalp blocks required)
- •Aphasia of comprehension preoperatively or expected postoperatively, or any other neurological impairment making pain self-assessment impossible
- •Contraindication to the use of local anesthetics: allergy or history of intoxication with local anesthetics
- •Patients with chronic pain or daily pre-operative morphine consumption
- •Contraindication to adrenaline infiltration: severe ventricular rhythm disorders, severe obstructive cardiomyopathy, unstable coronary insufficiency, hypersensitivity to adrenaline.
- •Pregnant or breast-feeding women
- •Patients under legal protection (persons deprived of their liberty or under guardianship).
结局指标
主要结局
Composite criterion of occurrence of events involving : - Either the need for morphine titration at a dosage greater than 0.05 mg.kg-1 in the immediate postoperative period (i.e., up to 6 h after extubation). - or the existence of severe pain defined by a numerical scale episode > 4 in the immediate post-operative period (i.e. up to 6 hours after extubation).
Composite criterion of occurrence of events involving : - Either the need for morphine titration at a dosage greater than 0.05 mg.kg-1 in the immediate postoperative period (i.e., up to 6 h after extubation). - or the existence of severe pain defined by a numerical scale episode > 4 in the immediate post-operative period (i.e. up to 6 hours after extubation).
次要结局
- ANI will be collected after induction, at the time of intubation, at the time of placement of the Mayfield frame and at the time of incision. Doses of hypnotic (propofol) and analgesic (remifentanil) will be recorded at these times.
- The numerical pain assessment scale will also be collected hourly up to 6 hours after extubation and at 24 hours post-operatively by the nurses in the continuous monitoring unit.
- The amount of morphine consumed on an hourly basis up to 6 hours after extubation and at 24 hours post-operatively will be collected using the computerized chart in the continuous care unit.
- The occurrence of post-operative nausea and vomiting will also be collected and defined by at least one of the following: the presence of nausea / the need for rescue antiemetic treatment / at least one episode of vomiting. This criterion is collected at 6 and 24 hours post-operatively on the basis of the data on the placard, and assessed by the nurses in the continuous monitoring unit in accordance with departmental practice.
- The presence of a persistent headache at 3 months post-op, not attributable to another cause, will be collected by telephone interview. The numerical scale of this headache, if any, the DN4 score and the need to take level 2 or 3 analgesics to treat this pain will also be collected in a declarative manner by telephone by an investigator blinded to the treatment group.
- The occurrence of surgical site infection will be collected at 3 months post-op.
- The number of nerves that may have been blocked by ultrasound for each patient will be collected at the time the scalp blocks are made by the practitioner performing them. The approach will also be recorded.
研究者
Principal Investigator
Scientific
Centre Hospitalier Universitaire De Bordeaux
