Partial Scalp Block Versus Fentanyl Infusion in Patients Undergoing Posterior Fossa Surgery Under General Anesthesia. A Randomized Control Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Systolic blood pressure at time of skin incision
研究概览
简要总结
Pain in patients undergoing posterior fossa surgery is regarded as more intense when compared to pain in patients undergoing supratentorial cranial surgeries. It may result in a rise in blood pressure and heart rate leading to serious effects as increased intracranial pressure and intracranial hemorrhage. For a long time, the control of pain has been the role of opioids. However, the use of opioids is not devoid of side effects. Hence, combining other techniques as partial scalp block with general anesthesia may be beneficial in controlling hemodynamics and decreasing the amount of opioids used without sacrificing the good quality of analgesia and anesthesia.
详细描述
Pain in patients undergoing posterior fossa surgery is regarded as more intense when compared to pain in patients undergoing supratentorial cranial surgeries. The main cause has been attributed to the substantial muscle dissection and trauma in this area.
Opioids remain as the current gold standard drugs for operative pain relief. However, exposure to large doses leads to multiple side effects of varying significance, such as nausea, vomiting, dizziness, constipation, respiratory depression, hypoventilation and disorders of breathing during sleep. Therefore, strategies other than opioids are recommended without sacrificing proper and effective analgesia.
Considering the previously mentioned facts, supplementing general anesthesia with regional anesthesia has been considered and was found to improve intraoperative hemodynamics, surgical field and postoperative analgesia.
In neurosurgery, scalp blocks and local anesthetic infiltration are being used along with general anesthesia either preoperatively to decrease the hemodynamic response to head pinning and surgical incision or postoperatively before emergence from anesthesia to decrease postoperative pain and result in a better outcome.
The current study aims to compare between partial scalp block(greater,lesser and third occipital nerve blocks) on the one hand versus fentanyl infusion on the other hand as pain controlling measures reflected on intraoperative hemodynamics in patients undergoing posterior fossa surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physical status ASA I and ASA ll.
- •Males and females between the ages of 21 and
- •Patients undergoing posterior fossa Surgeries.
- •Patients with GCS ≥14
- •Patients undergoing operation in prone position
排除标准
- •Patient refusal.
- •Patients with a history of allergy to opioids or local anesthetics
- •GCS (Glasgow coma score) ≤13 upon emergence from anesthesia.
- •Patients who will need post-operative ventilation
- •Patients who had previous craniotomies
- •Patients with contraindication to regional anaesthesia e.g.: local sepsis,
- •Patients with pre-existing peripheral neuropathies and coagulopathy.
- •Patients who will develop intraoperative surgical complications
- •Operations lasting more than 5 hours.
研究组 & 干预措施
Partial scalp block
Bilateral block of the greater lesser and third occipital nerves using bupivacaine 0.25% with epinephrine 1:200,000
干预措施: Partial scalp block (Drug)
Fentanyl group
Fentanyl infusion will be administered till time of dural closure
干预措施: Fentanyl (Drug)
结局指标
主要结局
Systolic blood pressure at time of skin incision
时间窗: During surgery, 1 min after skin incision
Recording of the systolic blood pressure in mmhg at the time of skin incision
次要结局
- Time for first rescue Analgesia(after the surgery)
- Number of heart beats per minute (Heart rate)(baseline, 5 min after the induction of anesthesia, 5 min after the scalp block, 1 min after skin incision, 1min after dural incision, at time of dural closure, 1 min after skin closure, at time of extubation.)
- Time to extubation(At the end of the operation, the time from the discontinuation of inhalation agents till extubation)
- RASS score(One hour after the surgery)
- Systolic blood pressure(baseline, 5 min after the induction of anesthesia, 5 min after the scalp block, 1 min after dural incision, at time of dural closure, 1 min after skin closure, at time of extubation.)
- Mean arterial blood pressure(baseline, 5 min after the induction of anesthesia, 5 min after the scalp block, 1 min after skin incision, 1 min after dural incision, at time of dural closure, 1 min after skin closure, at time of extubation.)
- Diastolic blood pressure(baseline, 5 min after the induction of anesthesia, 5 min after the scalp block, 1 min after skin incision, 1 min after dural incision, at time of dural closure, 1 min after skin closure, at time of extubation.)
- Number of intraoperative fentanyl boluses(During surgery)
- Intraoperative phentolamine consumption(throughout the operation)
- Intraoperative ephedrine consumption(throughout the operation)
研究者
Rania Samir Fahmy
Assistant professor of Anesthesia, ICU and pain medicine
Kasr El Aini Hospital