Effect Of Dexmedetomidine As An Adjuvant In Erector Spinae Plane Block On Postoperative Analgesia In Thoracolumbar Spine Surgery With An Opioid Free Anaesthesia Technique: A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To compare duration of pain free period postoperatively in patients receiving ESP block with ropivacaine and dexmedetomidine Vs ropivacaine alone.
研究概览
简要总结
Opioid Free Anaesthesia (OFA) is a multimodal nonopioid analgesic technique wherein use of opioids in any form is completely eliminated during anaesthesia. This new concept has emerged secondary to potential adverse effects of opioids.In light of the known adverse effects, there have been concerted efforts to reduce opioid exposure by utilising the non-opioid based alternatives analgesic techniques. These non-opioid based techniques are either administered systemically or at nerve root levels.Ketamine is a well-established anaesthetic agent which acts as NMDA receptor in addition to opioid receptors. It provides intense analgesia by reducing glutamate release due to its antagonist action on NMDA receptors and by binding to sigma-opioid receptors. Subanaesthetic doses of ketamine (0.5 mg/kg or less) is very effective in reducing postoperative pain score.Few studies have documented use of ESP block in spine surgery and observed lower pain scores postoperatively in ESP block group compared with systemic opioids. Dexmedetomidine, an alfa 2 receptors agonist, produces analgesia by acting on locus ceruleus of central nervous system and on both presynaptic and postsynaptic alfa 2 receptors at peripheral nervous system.We hypothesize that the addition of dexmedetomidine to local anaesthetic agent (ropivacaine) as an adjuvant in the ESP block will increase the duration of postoperative analgesia in spine surgery in ketamine based OFA technique.In this study, the effect of dexmedetomidine will be assessed as an adjuvant to ropivacaine in ESP block in thoracolumbar spine surgery done under ketamine based OFA on postoperative pain management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Age :18-65 years 2) Male/female 3) ASA 1 and 2 4) Patient posted for lower thoracic and upper lumber spine surgery (T8-L3) involving 2-4 intervertebral spaces.
- •Nontraumatic cases and Traumatic cases with no other skeletal trauma 6) Patient able to grade severity of pain.
排除标准
- •Preoperative pain score more than or equal to 5 2) BMI>35kg/m2 3) Pregnant or lactating woman 4) Patient with CAD/bradycardia/heart block/arrhythmias 5) Patient with hepatic/renal failure /CNS pathology 6) Patient with psychiatric disorder.
- •Patient not able to assess and tell severity of pain 8) Patients with allergies to any study medication.
- •Inability to position patient for block 10) ASIA A spine injury.
结局指标
主要结局
To compare duration of pain free period postoperatively in patients receiving ESP block with ropivacaine and dexmedetomidine Vs ropivacaine alone.
时间窗: 1) postoperative pain scores at 0,2,4,6,8,12 and 24 hrs | 2) rescue analgesic requirements during first 24 hour after surgery.
次要结局
- 1.To compare postoperative pain scores at 0,2,4,6,8,12 and 24 hrs(2.To compare rescue analgesic requirements during first 24 hour after surgery.)
