Opioid Free Anesthesia for Laparoscopic Cholecystectomy; A Randomized Control Trial at a Tertiary Care Hospital
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Heart Rate
研究概览
简要总结
The goal of this interventional study is to check the efficacy of Erector Spinae block as Opioid Free Anesthesia for Laparoscopic Cholecystectomy. Laparoscopic Cholecystectomy is a commonly performed day care procedure. Being a day care procedure the anesthetic technique employed should provide adequate analgesia, allow early mobilization of patient and should mitigate nausea and vomiting which occurs quite frequently in this surgical population. If these goals are achieved patients can be discharged early from hospital setting and this leads to overall cost benefits.
详细描述
One of the commonest presentations to surgical department is the abdominal pain caused by gall stones. The procedure of choice for treatment of cholelithiasis is Laparoscopic Cholecystectomy; a day care surgical procedure. This is performed under General Anesthesia with Endotracheal tube. During the surgery, anesthetist provides multi-modal analgesia in the form of opioids, NSAIDs and paracetamol. The commonly used Opioids in our setting include Morphine, Fentanyl and Nalbuphine. Opioids provides excellent analgesia but are associated with a number of side effects such as sedation, euphoria or dysphoria, respiratory depression, nausea, vomiting and increase in smooth muscle tone of the gut. These side effects can significantly impair the recovery in post-operative period, leading to prolong hospital stay. As a result opioid free anesthesia could be a suitable alternative to conventional opioid anesthesia for laparoscopic cholecystectomy. By avoiding the adverse effects of opioids; Opioid free anesthesia can lead to early recovery and discharge from the hospital.
One way to provide opioid free anesthesia is by utilizing loco-regional techniques. One of the loco-regional technique which has shown some benefit in laparoscopic cholecystectomy is erector spinae block. However in the available literature the block was utilized for providing post-operative analgesia in laparoscopic cholecystectomy. This Randomized Control Trial will check the efficacy of Erector Spinae Block in providing intra-operative as well as post operative analgesia in patients undergoing laparoscopic cholecystectomy.
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
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 16 years to 80 years.
- •American Society of Anesthesiologists (ASA) class: I and II.
- •Elective Laparoscopic Cholecystectomy under General Anesthesia.
- •Duration of surgery being less than 1h
排除标准
- •ASA class III or above
- •Neuromuscular disease
- •Body mass index >35 kg/m2
- •known allergy to drugs used in the study
- •Ischemic Heart disease, Cardiac Failure, Liver and renal insufficiency
- •Intra-operative conversion from laparoscopic to open procedure.
研究组 & 干预措施
Opioid Free Anesthesia Group
This will be the experimental group. Patient entering this group through computer generated random numbers will receive opioid free anesthesia in form of ultrasound guided Erector Spinae Block given bilaterally at T6 level.
干预措施: Erector Spinae Block (Procedure)
Conventional Opioid group
Patient entering this group through computer generated random numbers will receive opioid based anesthesia.
干预措施: Opioid Analgesic (Drug)
结局指标
主要结局
Heart Rate
时间窗: Baseline, immediately at/after skin incision, after generation of pneumoperitoneum, and at the end of surgery.
Heart Rate is measured as a part of standard ASA monitoring through electronic cardiac monitor showing electrocardiogram as well as heart rate (no. of beats/min).
Blood Pressure
时间窗: Baseline, immediately at/after skin incision, after generation of pneumoperitoneum, and at the end of surgery
Blood pressure including Systolic, Diastolic and Mean arterial pressure is measured as a part of standard ASA monitoring. This is measured in units of mm of Hg through automated Non-invasive Blood pressure monitoring device.
Post operative pain control
时间窗: This will be assessed upon patient arrival at Post anesthesia care unit and then 1 hourly interval till 6hours. The pain will be assessed both on rest as well as on cough.
This will be assessed using Visual Analog Scale (VAS)
次要结局
- Intra operative rescue Opioid consumption(Amount of Fentanyl given Intravenously from the time till skin incision to the time at end of surgery)
- Post operative analgesic consumption(From arrival in the PACU till 6 hours.)
研究者
Muhammad Haroon Anwar
Principal Investigator, Department of Anaesthesia and Critical Care Medicine
Pakistan Institute of Medical Sciences