Effects of pregabalin on perioperative opioid-sparing effects on patients undergoing craniotomies for brain tumors. A Randomized, double-blinded, placebo controlled study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- a]Total intra-operative opioid consumption
研究概览
简要总结
• A craniotomy is a neurosurgical procedure done to get a wide cranial opening for doing surgical therapeutic maneuvers. Posi-craniotomy pain is a common entity. Pain can elicit a complex set of neural, and cardiac. and respiratory changes, leading to increased cerebral blood flow and intracranial pressure, cerebral edema, and even intracranial bleeding operative analgesics. Traditionally, opioids are being used in craniotomy cases for induction, intraoperative pain management, and post• operative pain management. Opioids are potent analgesics but their usage can interfere with neurological monitoring and are associated with serious side effects like PONV, constipation, pruritis, sedation, opioid-induced hyperalgesia (OIH), and life-threatening respiratory depression. Pregabalin has been evaluated for postoperative analgesia in orthopedic and spine surgeries, laparoscopic hysterectomy, laparoscopic cholecystectomy, and thoracotomy, etc., Preemptive use of gabapentinoids is also known to effectively reduce opioid consumption There is a deficiency of trials investigating its effects in attenuating perioperative pain in intracranial surgeries. This study was designed to evaluate the opioid-sparing effect of preoperative pregabalin in patients undergoing craniotomy for brain tumors Studies of pregabalin in neurosurgical patients are scarce. There are only a few published randomized studies of pregabalin use for analgesia in patients undergoing craniotomy and these limited studies compare pre-emptive pregabalin and gabapentin and their opioid-sparing effects. However, these studies have some drawbacks like using sub-therapeutic doses of pregabalin, non-consideration of opioid side effects, and prolonged postoperative use of pregabalin, which we would like to correct in our study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •Patients of either gender 2) Age 18–65 years 3) ASA class I, II 4) Patients with GCS 15 5) Scheduled for elective craniotomies for excision of brain tumors.
排除标准
- •Allergy to study drugs and opioid dependence.
- •Patients undergoing emergency surgery.
- •Patients receiving chronic neuroleptics, tricyclic antidepressants, serotonin noradrenaline reuptake inhibitors.
结局指标
主要结局
a]Total intra-operative opioid consumption
时间窗: a]Till 12 hours postoperative | b]Till 12 hours postoperative
b] Post-operative pain scores and rescue analgesia.
时间窗: a]Till 12 hours postoperative | b]Till 12 hours postoperative
次要结局
- a] Incidence of adverse effects of opioids like PONV, shivering.(b] Incidence of emergence delirium and delayed recovery.)
研究者
Dr Sai Saravanan K
AIIMS, RAIPUR
