Effect of Sphenopalatine Ganglion Block With Bupivacaine on Postoperative Pain in Patients Undergoing Endoscopic Pituitary Adenoma Resection
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Post-operative pain score
研究概览
简要总结
To assess the benefit of using an additional nerve block during minimally invasive pituitary surgery, to improve pain management after surgery. The medication (Bupivacaine) or a placebo (saline) will be injected during surgery and patients will be asked about their level of pain at multiple time points in the first 24 hours following surgery. Some patients will be randomized to a third, sham group that do not receive any additional injection. The aim is to improve patient outcomes and reduce the need for pain medication after surgery.
详细描述
To further improve the quality of the early postoperative course, the investigators propose the use of the sphenopalatine ganglion (SPG) block (SPGB) for pain management in the context of an enhanced recovery after surgery (ERAS) protocol for minimally invasive (MIS) endoscopic transsphenoidal pituitary surgery. The SPG is the main sensory innervation to the nasal mucosa, and several studies have shown the analgesic efficacy of SPGB following sinus surgery and showed positive results for endoscopic sinus surgery. However, there is limited research on the use of SPGB in the context of pituitary surgery.
In this randomized placebo-controlled trial, the investigators aim to assess the benefit of SPGB with bupivacaine in addition to multimodal general anesthesia on pain management, after MIS pituitary surgery. The results of the trial will provide valuable insights into the potential benefits of SPGB and its optimal use for pituitary surgery.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients (18 yrs or older)
- •undergoing endonasal pituitary adenoma resection
排除标准
- •Patients with pre-existing chronic pain conditions requiring antidepressants (serotonin reuptake inhibitors), benzodiazepines, gabapentin, or opioid drugs
- •contraindications to the performance of SPGB such as known allergy to used medications
- •chronic alcohol abuse
- •uncontrolled systemic arterial hypertension
- •severe kidney or liver diseases
- •cardiomyopathies or sustained cardiac arrhythmias (permanent paroxystic atrial fibrillation or other sustained supraventricular rhythmic anomalies)
研究组 & 干预措施
Placebo Control
This group will receive bilateral injection of 0.9% saline solution using a 20G needle and comprising 2mL of fluid on each side (4mL total) into the sphenopalatine ganglion.
干预措施: Placebo (Drug)
Sham - no injection
Participants randomized to this arm will not receive any additional study injections and will undergo the current standard procedure for patients undergoing endoscopic endonasal surgery.
干预措施: Sham Comparator (Drug)
Bupivacaine injection
This group will receive bilateral injection of 0.5% bupivacaine with 1:200,000 epinephrine using a 20G needle and comprising 2mL of fluid on each side (4mL total) into the sphenopalatine ganglion.
干预措施: Bupivacaine-Epinephrine 0.5%-1:200,000 Injectable Solution (Drug)
结局指标
主要结局
Post-operative pain score
时间窗: through study completion, approximately 1 year
Pain score, measured by visual analog scale (scale of 0-10) at 6, 12 and 24 hours post-op
次要结局
- Post-operative bleeding(through study completion, approximately 1 year)
- Analgesic requirement(through study completion, approximately 1 year)
- Length of stay(through study completion, approximately 1 year)
- Post-operative complications(through study completion, approximately 1 year)