Comparative Study Between Efficacy of Ultrasound-Guided Bilateral Erector Spinae Plane Block and Thoracic Paravertebral Block on Perioperative Analgesia and Fast Recovery of Patients Undergoing Laparoscopic Sleeve Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time to first Rescue Analgesia
研究概览
简要总结
The aim of this study is to compare the efficacy of ultrasound-guided bilateral erector spinae plane block and thoracic paravertebral block on perioperative analgesic control for 24 hours postoperative and fast recovery of patients undergoing laparoscopic sleeve gastrectomy using the Visual Analogue Scale.
详细描述
Obesity was ranked as the 5th preventable cause of death and is associated with certain diseases as non-insulin dependent diabetes mellitus, hypertension, ischemic heart disease, hyperlipidemia, and sleep apnea. Egypt has the world's 18th highest obesity prevalence, according to the World Health Organization (WHO).
Bariatric surgery has been advocated for adults with severe obesity for weight reduction purposes and lowering the health risks linked to obesity. Laparoscopic sleeve gastrectomy (LSG) is considered an efficient approach to bariatric surgery which provides an apparent weight loss and an improved weight-related quality of life with reduced postoperative morbidity but is frequently complicated by moderate to severe pain especially in the immediate postoperative period.
The Enhanced Recovery After Surgery (ERAS) recommendations for bariatric surgery currently advocate the utilization of regional anesthesia techniques, which constitute a valuable component of opioid sparing multimodal analgesia strategies to reduce intraoperative and postoperative narcotics consumption. Poorly controlled postsurgical pain is linked to decreased quality of care, surgical complications, prolonged immobility, rehabilitation and hospitalization, development of chronic pain, higher treatment costs, and a heavy burden on the healthcare system.
In 2016, the ultrasound (US)-guided erector spinae plane block (ESPB) was first described to treat thoracic neuropathic pain. The ESPB local anesthetic injectant into the fascial plane deep to the erector spinae muscle with craniocaudal distribution has an analgesic impact on somatic and visceral pain. It causes both somatic and visceral sensory blockade via acting on the ventral and dorsal rami of spinal nerves. The ESPB can provide analgesia to abdominal operations performed at a lower thoracic vertebral level (T7 or T8). However, the main concern with the ESPB is feasibility together with the potency of the block in challenging populations, such as patients suffering from obesity.
Thoracic paravertebral block (TPVB) is a classic trunk block with definite analgesic effect for both somatic and visceral pain through injecting local anaesthetic alongside the thoracic vertebrae and close to where the spinal nerves emerge from the intervertebral foramen. It produces ipsilateral, somatic and sympathetic nerve blockade in multiple contiguous thoracic dermatomes that culminate in high-quality afferent nociceptive blockade. Despite its wide use in thoracic procedures, to date, few studies have assessed the effectiveness of Thoracic paravertebral block (TPVB) in laparoscopic abdominal surgeries in an adult population.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 21 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 21 to 60 years.
- •Sex: males and females
- •Patients with American Society of Anesthesiologists physical status 4.classifications II-III undergoing laparoscopic sleeve gastrectomy under general anaesthesia.
排除标准
- •Patient refusing to participate in the study.
- •Patients with bleeding disorders.
- •A history of relevant local anaesthetic allergy.
- •Patients with muscle diseases.
- •Evidence of local infection at site of injection.
- •Pre-existing chronic pain or cognitive dysfunction (which would impede accurate engagement with postoperative quality of recovery and analgesia assessment)
研究组 & 干预措施
Erector spinae plane block group (ESPB)
Group (I): 15 participants will be injected with 30 mL of 0.25% bupivacaine deep to the erector spinae muscle.
干预措施: Erector Spinae Plane Block (Procedure)
Thoracic paravertebral block group (TPVB)
Group (II): 15 participants will be injected with 25 ml of 0.25% bupivacaine into paravertebral space of T7 vertebra.
干预措施: Thoracic paravertebral block (Procedure)
结局指标
主要结局
Time to first Rescue Analgesia
时间窗: Postoperative pain will be assessed using Visual Analogue Scale at rest (VAS-R) and with movement (VAS-M) at 30 minutes postoperative and 2, 4, 6, 8, 12, and 24 hours after surgery and Meperidine will be given accordingly.
25 mg IV Meperidine (Pethidine) will be given as a rescue analgesia if patients complained of postoperative pain and their Visual Analogue Scale for pain ≥ 3 and to be repeated if patients continue to complain. Time to first rescue analgesia will be recorded. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient will be asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark defines the subject's pain. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[100-mm scale\]).
次要结局
- mean Meperidine consumption(24 hours postoperatively)
- Heart rate(24 hours postoperatively)
- Visual Analogue Scale for pain(Postoperative pain will be assessed using Visual Analogue Scale at rest (VAS-R) and with movement (VAS-M) at 30 minutes postoperative and 2, 4, 6, 8, 12, and 24 hours after surgery.)
- Time to perform the block(Time needed to perform the block intraoperative before induction of general anaesthesia will be recorded.)
- Time to first ambulation(24 hours postoperatively)
- Systolic, Diastolic and Mean arterial blood pressures(24 hours postoperatively)
研究者
Alaa Mohamed Ahmed Ahmed
Dr.
Ain Shams University
