Perioperative Analgesic Management Using Conventional Versus Regional Nerve Block in Craniotomy Surgeries in Lower Middle-Income Class Countries
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Intraoperative Heart Rate Response to Noxious Stimuli
研究概览
简要总结
The goal of this randomized controlled clinical trial is to compare the effectiveness of systemic opioids versus pre-incision bilateral scalp nerve block in managing intraoperative noxious stimuli and postoperative pain in adult patients (18-75 years) undergoing elective supratentorial craniotomy.
The main questions this study aims to answer are:
Does pre-incision bilateral scalp nerve block provide better intraoperative hemodynamic stability compared to systemic opioids?
Does it result in lower postoperative pain scores and reduced opioid consumption during the first 24 hours after surgery?
Researchers will compare Group M (systemic morphine) with Group S (bilateral scalp nerve block) to see if the scalp nerve block offers superior analgesia and fewer opioid-related side effects.
Participants will:
Be randomly assigned to receive either systemic morphine or bilateral scalp nerve block before incision.
Undergo standard general anesthesia for craniotomy.
Have postoperative pain managed using a patient-controlled analgesia (PCA) morphine pump and be monitored for 24 hours for pain, sedation, and nausea/vomiting scores
详细描述
This double blinded, randomized controlled trial was conducted at Aga Khan University Hospital, Karachi, over a period of three to six months after obtaining approval from the institutional ethics committee. Non-probability consecutive sampling was used.
Eligible patients were randomly assigned using computer-generated randomization into two groups: Group M (morphine) and Group S (scalp nerve block). Pre-operatively, all patients were given explanations of the visual analogue scale (VAS) scores for pain assessment and how to operate the patient-controlled analgesia (PCA) machine for post-operative analgesia. Baseline heart rate and blood pressure were recorded after applying standard ASA monitors. Group M was given IV Morphine at induction 0.1mg/kg. In Group S, a bilateral scalp nerve block was performed after arterial line insertion using a mixture of lidocaine 0.1%, ropivacaine 0.25%, adrenaline 1:200,000, and dexamethasone 4 mg. The supraorbital, supratrochlear, auriculotemporal, zygomaticotemporal, greater, and lesser occipital nerves were blocked. In Group M, only pin sites were infiltrated with the same solution.
Intraoperative heart rate, systolic, diastolic, and mean arterial pressures were recorded at multiple surgical stages. Postoperatively, all patients received PCA morphine (1 mg/ml, 1 mg bolus, 10-minute lockout, no background infusion). Pain (VAS), sedation, and nausea/vomiting scores were assessed up to 24 hours postoperatively by a blinded observer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years to 75 years,
- •American Society of Anesthesiologists class I-III,
- •Scheduled for supratentorial craniotomy.
排除标准
- •Patient with Glasgow Coma Score (GCS) of less than 15,
- •Inability to understand the Visual analog scale (VAS)
- •Allergic to study drugs (Morphine and local anesthetics)
- •Patient chronically treated with narcotic medications.
- •History of Liver dysfunction
研究组 & 干预措施
Bilateral Scalp Nerve Block (SNB)
Participants receive a bilateral scalp nerve block after arterial line insertion using local anesthetic agents with adjuvants.
干预措施: Ropivacaine (Drug)
Bilateral Scalp Nerve Block (SNB)
Participants receive a bilateral scalp nerve block after arterial line insertion using local anesthetic agents with adjuvants.
干预措施: Epinephrine (Adrenaline) (Drug)
Bilateral Scalp Nerve Block (SNB)
Participants receive a bilateral scalp nerve block after arterial line insertion using local anesthetic agents with adjuvants.
干预措施: Dexamethasone (Drug)
Intravenous Morphine
Participants receive intravenous Morphine 0.1mg/kg at induction.
干预措施: Morphine (Drug)
Bilateral Scalp Nerve Block (SNB)
Participants receive a bilateral scalp nerve block after arterial line insertion using local anesthetic agents with adjuvants.
干预措施: Scalp nerve block (Procedure)
Bilateral Scalp Nerve Block (SNB)
Participants receive a bilateral scalp nerve block after arterial line insertion using local anesthetic agents with adjuvants.
干预措施: Lidocaine (Drug)
结局指标
主要结局
Intraoperative Heart Rate Response to Noxious Stimuli
时间窗: Intraoperative Period- from induction of anesthesia until skin closure.
Heart rate (beats per minute) will be recorded on various noxious stimuli such as on intubation, 3 minutes after intubation, prior to scalp nerve block, 3 minutes after scalp nerve block, before head pinning, 1 and 3 minutes after head pinning, at surgical incision, 3 minutes after skin incision, during bone and periosteum dissection, Dural opening, Dural closing, skull bone closure, skin closure in patients undergoing for the supratentorial craniotomy.
Intraoperative Systolic Blood Pressure Response to Noxious Stimuli
时间窗: Intraoperative Period- from induction of anesthesia until skin closure.
Systolic blood pressure (mmHg) measured at various noxious stimuli such as on intubation, 3 minutes after intubation, prior to scalp nerve block, 3 minutes after scalp nerve block, before head pinning, 1 and 3 minutes after head pinning, at surgical incision, 3 minutes after skin incision, during bone and periosteum dissection, Dural opening, Dural closing, skull bone closure, skin closure in patients undergoing for the supratentorial craniotomy.
Intraoperative Diastolic Blood Pressure Response to Noxious Stimuli
时间窗: Intraoperative Period- from induction of anesthesia until skin closure.
Diastolic blood pressure (mmHg) measured at various noxious stimuli such as on intubation, 3 minutes after intubation, prior to scalp nerve block, 3 minutes after scalp nerve block, before head pinning, 1 and 3 minutes after head pinning, at surgical incision, 3 minutes after skin incision, during bone and periosteum dissection, Dural opening, Dural closing, skull bone closure, skin closure in patients undergoing for the supratentorial craniotomy.
Intraoperative Mean Arterial Pressure Response to Noxious Stimuli
时间窗: Intraoperative Period- from induction of anesthesia until skin closure.
Mean arterial pressure (mmHg) measured at various noxious stimuli such as on intubation, 3 minutes after intubation, prior to scalp nerve block, 3 minutes after scalp nerve block, before head pinning, 1 and 3 minutes after head pinning, at surgical incision, 3 minutes after skin incision, during bone and periosteum dissection, Dural opening, Dural closing, skull bone closure, skin closure in patients undergoing for the supratentorial craniotomy.
次要结局
- Incidence of Postoperative Nausea/ Vomiting Within 24 Hours(0-24 hours postoperatively)
- Postoperative Sedation Score Measured by 4-Point Sedation Scale(0-24 hours postoperatively)
- Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)(0-24 hours postoperatively)
- Total Postoperative Morphine Consumption in First 24 Hours(0-24 hours postoperatively)
研究者
Dileep Kumar
Associate Professor
Aga Khan University