EFFECTIVENESS OF BILATERAL ULTRASOUND GUIDED SPHENOPALATINE BLOCK FOR INTRAOPERATIVE ANALGESIA IN ENDOSCOPIC TRANS-NASAL TRANS-SPHENOIDAL RESECTION OF PITUITARY TUMOR UNDER GENERAL ANAESTHESIA: AN OPEN LABEL COMPARATIVE STUDY.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- To compare the intra-operative pain (using Analgesia Nociceptive Index) and opioid consumption in patients undergoing Endoscopic Trans-nasal Trans-sphenoidal Resection of pituitary tumors receiving bilateral USG guided SPG block vs no block.
研究概览
简要总结
The trans-nasal trans-sphenoidal (TNTS) resection of pituitary tumors can lead to significant hemodynamic changes due to brief but intense pain stimuli during the nasal and sphenoidal stages of the procedure, as well as during the dissection of the sellar region. This pain is attributed to the manipulation of sensitive mucosal tissues and structures within the nasal cavity and sphenoid sinus, which can lead to substantial discomfort for the patient. Many regional techniques have been used during resection of pituitary adenoma including infiltration of LA, bilateral sphenopalatine ganglion block, maxillary nerve block and bilateral infraorbital nerve block. This study aims to compare the intra-operative nociception levels, opioid consumption, postoperative analgesia and recovery characteristics in patients undergoing Endoscopic Trans-nasal Trans-sphenoidal Resection of Pituitary Tumors receiving bilateral ultrasound guided SPG block vs no block.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •All adult patients scheduled for elective endoscopic Trans-nasal Trans-sphenoidal approach for resection of pituitary tumor will be included in the study.
排除标准
- •Patients who refuse to give consent, Pre-exisiting Uncontrolled hypertension and diabetes, Coagulopathy or bleeding tendency, Pre-operative Glasgow Coma Scale <15, those who receive dexmedetomidine infusions intraoperatively.
结局指标
主要结局
To compare the intra-operative pain (using Analgesia Nociceptive Index) and opioid consumption in patients undergoing Endoscopic Trans-nasal Trans-sphenoidal Resection of pituitary tumors receiving bilateral USG guided SPG block vs no block.
时间窗: Data (HR, MAP, SPI, ANIi and ANIm) will be collected every minute for five minutes (T1 – T5) prior to and after the noxious stimuli during surgery.
次要结局
- 1) To compare intra-operative Analgesia Nociception Index (ANI) & Surgical Pleth Index (SPI) with the hemodynamic parameters at various stages of noxious stimulus within the group & between the groups.(2) To compare rescue analgesia between the groups during intraoperative period & up to 48 hours after the surgery.)
研究者
Dr Dhanalakshmi R
National Institute of Mental Health and Neuro Sciences