Effects of SCALP Block on Postoperative Analgesia in Craniotomy Surgery: A Prospective, Randomized Controlled, Double-Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Scalp
研究概览
简要总结
Patients undergoing craniotomy surgery often experience severe postoperative pain. This pain can affect the patient's hemodynamics, disrupt sleep patterns, and prolong hospital stays. Sudden increases in heart rate and blood pressure due to pain may lead to elevated intracranial pressure in patients, potentially causing morbidity and mortality. Opioids are commonly used to mitigate hemodynamic fluctuations and reduce postoperative pain; however, they may delay recovery, contribute to excessive sedation, and affect postoperative neurological examinations. Additionally, opioids have adverse effects such as nausea, vomiting, and respiratory depression. Alleviating hemodynamic instability and postoperative pain are critical concerns for neuro anesthesiologists. Regional analgesia techniques are employed in neurosurgery patients because they minimize anesthesia requirements, alleviate pain, and allow for neurological assessment with a lower incidence of systemic complications.The scalp block was developed due to its potential benefits as an effective regional anesthesia technique that supports the advancement of delicate brain surgeries such as functional and microsurgeries.
详细描述
In this study, we hypothesize that patients who receive a SCALP block will have lower postoperative Numerical Rating Scale scores and consume less total analgesia.
Our primary objective is to evaluate postoperative numerical rating scale scores in patients undergoing craniotomy surgery with a SCALP block.
Our secondary objectives are to assess the total amount of rescue analgesia consumed, the time to first rescue analgesia, patient satisfaction, and any possible complications. The study was planned as a prospective, randomized, controlled, double blind. At each clinic, an anesthesiologist randomly allocated patients to two significant groups using numbered opaque sealed envelopes: Group S (patients receiving SCALP block) and Group C (patients getting just multimodal analgesia). The anesthesiologists responsible for the randomization process were not involved in any other sections of the trial, and the individuals executing the SCALP blocks procedure were not engaged in other areas of the research. Additionally, the researcher who intervened, the participants, and the analyzer were blinded to the details of the study. After the surgery, two different anesthesia technicians recorded the primary and secondary results of the study.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •18-65 years
- •General anesthesia
- •American Society of Anesthesiologists physical status I-III
排除标准
- •Contraindications to regional anesthesia
- •Coagulation disorders
- •Known allergy to local anesthetics
- •Infections at the block site
- •Pregnant patients
- •Emergency cases
结局指标
主要结局
Scalp
时间窗: One day
Our primary objective is to evaluate postoperative numerical rating scale scores in patients undergoing craniotomy surgery with a SCALP block. (Numerical rating scale score 0-10 point. 0= Very Bad, 10= Very Good
次要结局
未报告次要终点
研究者
Muhammed Halit Satici
Specialist, Department of Anesthesiology, Konya City Hospital, M.D
Konya City Hospital