Comparing the Quality of Recovery of Erector Spinae Block Versus Ketamine-based Multimodal Analgesia Protocol in Lumber Decompressive Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- quality of recovery
研究概览
简要总结
The aim of this study is to compare the quality of recovery of the erector spinae plane block (ESPB) versus ketamine-based multimodal analgesia regimen after spine decompressive surgery.
详细描述
Preoperatively, standard monitors will be attached (electrocardiogram, noninvasive blood pressure, and pulse oximetry) and intravenous access will be obtained. Dexamethasone will be administered at dose of 4 mg as an antiemetic prophylaxis.
Thirty min before induction of anesthesia all patients will receive 15 mg ketorolac and 1 gm paracetamol intravenously.
General anesthesia will be induced by 1 mcg/kg fentanyl and 2 mg/kg propofol titrated till loss of verbal response. Tracheal intubation will be facilitated by 0.5 mg/kg atracurium. General anesthesia will be maintained by isoflurane (end-tidal isoflurane concentration of 1-1.2%) in air-oxygen admixture.
Fentanyl boluses of 50 mcg will be given in case of inadequate analgesia (heart rate and or systolic blood pressure increase by 20% from the baseline in absence of other causes) Intraoperative hemodynamic management will be according to the discretion of the attending anesthetist.
Postoperatively, all Patients will receive oral 1 gm of paracetamol every 6 h and 400 mg ibuprofen every 8 h.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) status of I-III
- •scheduled for open lumber decompression surgery for degenerative stenosis or trauma involving 1or 2 levels without fusion.
排除标准
- •Refusal to participate
- •Contraindication for peripheral regional anesthesia such as infection and coagulopathy.
- •Inability to comprehend the Numeric Rating Scale (NRS) or Patients who has cognitive function impairment
- •Preoperative renal or hepatic insufficiency
- •History of Opioid abuse.
- •Allergy to any of the study drugs
研究组 & 干预措施
ketamine group
Patients will be receiving ketamine bolus then continuous infusion and local wound infiltration at the end of the surgery.
干预措施: ketamine (Drug)
ketamine group
Patients will be receiving ketamine bolus then continuous infusion and local wound infiltration at the end of the surgery.
干预措施: Wound infiltration (Other)
ESPB group
Patients will be receiving erector spinae plane block
干预措施: Erector Spinae Plane Block (Other)
结局指标
主要结局
quality of recovery
时间窗: 24 hour to 25 hour after surgery
using the QoR-15 questionnaire
次要结局
- pain assessment(30 minutes postoperatively till 24 hours postoperatively)
- nalbuphine requirement(30 minutes postoperatively till 24 hours postoperatively)
- time to rescue analgesia(30 minutes postoperatively till 24 hours postoperatively)
研究者
Maha Mostafa Ahmad, MD
Principal Investigator
Kasr El Aini Hospital