Impact of Transnasal Sphenopalatine Ganglion Block on Pain Relief and Recovery Following Tonsillectomy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Postoperative NRS Score and Opioid Consumption
研究概览
简要总结
The aim of this clinical trial is to evaluate the effectiveness of transnasal transmucosal sphenopalatine ganglion block in reducing post-tonsillectomy pain. The study also investigates its impact on rescue analgesic requirements and postoperative recovery by comparing 5% lidocaine with placebo.
Participants will receive a transnasal transmucosal sphenopalatine ganglion block with either 5% lidocaine or placebo (saline). Postoperative pain levels and opioid consumption will be monitored during the first 24 hours after surgery. In addition, length of hospital stay, the occurrence of primary and secondary post-tonsillectomy hemorrhage up to 14 days, unplanned hospital readmissions after discharge, and patient satisfaction on postoperative day 14 will be assessed.
详细描述
The primary objective of this study is to compare the effects of preemptive transnasal transmucosal sphenopalatine ganglion block performed with either 0.9% saline (placebo) or 5% lidocaine (active drug), in addition to standard multimodal analgesia, on postoperative pain and recovery in patients aged 12 years and older undergoing tonsillectomy.
All patients will undergo routine monitoring, including noninvasive blood pressure, electrocardiography (ECG), peripheral oxygen saturation (SpO₂), body temperature, end-tidal carbon dioxide (ETCO₂), and bispectral index (BIS), followed by induction of general anesthesia.
For induction of general anesthesia, intravenous lidocaine 1 mg/kg, fentanyl 1 µg/kg, and propofol 1-3 mg/kg (adjusted according to depth of anesthesia monitoring) will be administered. Neuromuscular blockade required for endotracheal intubation and surgery will be achieved with intravenous rocuronium 0.8 mg/kg. Airway security will be ensured by orotracheal intubation. Anesthesia maintenance will be provided as total intravenous anesthesia (TIVA) using a propofol and remifentanil combination, guided by BIS monitoring.
Immediately after induction of anesthesia, patients will be randomized into either the Saline Group (placebo) or the Lidocaine Group (5% lidocaine, active drug) using a computer-generated randomization program.
Before the start of surgery, a preemptive transnasal transmucosal sphenopalatine ganglion block will be performed. Patients in the placebo group will receive 0.9% isotonic saline, while patients in the lidocaine group will receive 5% lidocaine. Cotton-tipped applicators will be used for the block procedure, with one applicator inserted into each nostril. The applicators will be advanced parallel to the nasal floor from the middle turbinate until resistance is encountered. Contact of the applicator with the posterior wall of the nasopharynx will ensure transmucosal proximity to the sphenopalatine ganglion. The assigned solutions will be applied via the applicators according to group allocation, aiming for transmucosal absorption and therapeutic effect on the target ganglion.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 12 years
- •Patients weighing ≥ 50 kg
- •Patients without coagulation disorders
- •ASA physical status I-II patients scheduled for tonsillectomy
- •Patients who are fully oriented and able to cooperate
排除标准
- •Lack of informed consent
- •Patients aged < 12 years
- •Patients weighing < 50 kg
- •Body mass index (BMI) > 30 kg/m²
- •History of allergy to local anesthetics
- •History of facial trauma or infection
- •Presence of coagulation disorders
- •Patients who are disoriented and/or unable to cooperate
- •Patients with comorbidities requiring opioid use
- •History of neuropathic pain
- •Patients with chronic pain syndrome
研究组 & 干预措施
Group Lidocain
Transnasal sphenopalatine ganglion block will be performed using cotton-tipped applicators soaked with 5% lidocaine hydrochloride, which will be prepared by diluting 10% lidocaine hydrochloride with 0.9% sodium chloride (normal saline).
干预措施: Lidocaine %5 (Procedure)
Group Lidocain
Transnasal sphenopalatine ganglion block will be performed using cotton-tipped applicators soaked with 5% lidocaine hydrochloride, which will be prepared by diluting 10% lidocaine hydrochloride with 0.9% sodium chloride (normal saline).
干预措施: Transnasal Transmucosal Sphenopalatine Ganglion Block (Procedure)
Group Saline
In the comparison group, a transnasal sphenopalatine ganglion block will be performed as a placebo using cotton-tipped applicators soaked with 0.9% sodium chloride (normal saline).
干预措施: Transnasal Transmucosal Sphenopalatine Ganglion Block (Procedure)
Group Saline
In the comparison group, a transnasal sphenopalatine ganglion block will be performed as a placebo using cotton-tipped applicators soaked with 0.9% sodium chloride (normal saline).
干预措施: Saline (0.9% NaCl) (Procedure)
结局指标
主要结局
Postoperative NRS Score and Opioid Consumption
时间窗: Postoperative 1. 2. 4. 8. 16. and 24. Hours
The NRS (Numeric Rating Scale) score will be used to assess the pain during follow ups. Scale: 0 (no pain) to 10 (worst pain). Higher scores on the NRS indicate worse pain.
次要结局
- Parameters for Postoperative Complications and Recovery Process(Postoperative 14th Day)
- Feeding Tolerance and Time to First Tolerated Oral Intake(Postoperative 1.2.4.8.16. and 24. Hours)
研究者
Sıddık Aytuğ
MD Sıddık Aytuğ Medical Resident
Ankara University