Bilateral sphenopalatine ganglion block using ultrasound in endoscopic sinus surgery for postoperative pain reduction and surgical field visualization during the surgery: a randomized controlled study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To evaluate the effect of ultrasound-guided sphenopalatine ganglion block on post-operative pain for 24 hours and surgical field visualization during surgery in patients undergoing functional endoscopic sinus surgery.
研究概览
简要总结
Evaluating the Effect of Bilateral Sphenopalatine Ganglion Block on Postoperative Pain and Surgical Visibility in Functional Endoscopic Sinus Surgery (FESS) Using Ultrasound Guidance.
Aim: To assess the impact of a bilateral sphenopalatine ganglion block administered via the suprazygomatic approach under ultrasound guidance on postoperative pain and the clarity of the surgical field during FESS.
Objectives
- Primary Objective: To determine the effect of the block on postoperative pain (for 24 hours) and on surgical field visualization during FESS.
- Secondary Objectives:
- Assess hemodynamic response to the block.
- Compare intraoperative blood loss between patients receiving and not receiving the block.
- Analyze intraoperative and postoperative analgesic consumption.
Methodology
- Study Design: Prospective, double-blinded, randomized control trial conducted over 18 months.
- Participants: 70 adult patients (35 per group) aged 18–65 years, ASA physical status I and II, scheduled for elective FESS under general anesthesia.
- Randomization: Participants are randomly divided into two groups: GROUP A one receiving the sphenopalatine ganglion block with 0.5% ropivacaine and dexamethasone, GROUP B the other not receiving the block.
InterventionPatients undergo general anesthesia, and the block is administered under ultrasound guidance by an expert anesthetist using a 27-gauge needle for precise targeting. Both groups are monitored for hemodynamic stability, intraoperative bleeding (using Formme-Boezaart scale), and the surgical field’s visual clarity. Postoperative pain is assessed at 2, 6, and 12 hours using a numerical rating scale, and analgesia requirements are recorded.
Data AnalysisData will be analyzed using SPSS software with appropriate statistical tests (t-tests, ANOVA, chi-square) to compare means, medians, and associations between groups, with significance set at p < 0.05.
Endpoints
- Primary: Reduction in postoperative pain and improvement in surgical visualization.
- Secondary: Hemodynamic stability, blood loss, and opioid consumption during surgery.
This study aims to enhance postoperative comfort and surgical efficiency in FESS through optimized pain management and surgical field visibility by using a targeted nerve block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Adult patients between 18 to 65 years of age of either gender ASA I and II scheduled for elective FESS under general anaesthesia.
排除标准
- •Patients without consent.
- •Patients who are allergic to the study drug.
- •Patient bleeding diathesis.
- •PATIENT with a history of facial trauma.
- •Any systemic or local infection at the site of the needle insertion.
结局指标
主要结局
To evaluate the effect of ultrasound-guided sphenopalatine ganglion block on post-operative pain for 24 hours and surgical field visualization during surgery in patients undergoing functional endoscopic sinus surgery.
时间窗: 24 hours post operatively
次要结局
- To study the hemodynamic response to sphenopalatine ganglion block in FESS surgery(Intraoperatively)
- • To compare the blood loss with the patients receiving sphenopalatine ganglion block & those who are not receiving block.(intraoperatively)
- • To compare post-operative & intraoperative analgesia consumption among the patients receiving sphenopalatine ganglion block & those not receiving block.(24 hrs post operatively)
研究者
Rithik joshy
AIIMS Bathinda