Post-operative Pain Control With Sphenopalantine Ganglion Nerve Block in Septorhinoplasty Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Decrease the opioid requirement post-operatively as assessed by providers.
研究概览
简要总结
Maxillary nerve blocks have been shown to significantly reduce post-operative pain and analgesic intake during the 24-hour period following sinus surgery. This randomized, double-blinded, placebo-controlled study will investigate blocks of the sphenopalatine ganglion using a suprazygomatic approach during septorhinoplasty surgery. It is the investigator's hypothesis that this technique will result in decreased post-operative pain and opioid use, and the morbidity associated with it.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient presenting for open or endoscopic septorhinoplasty
- •Age 18-80
- •Normal oral food and water intake before surgery
- •ASA physical classification 1-3
排除标准
- •Refusal to consent
- •Patients without a cellular phone or who are unable to accept text messages
- •Allergy to opioid narcotics
- •ASA physical classification of 4 or higher
- •Patient requires other surgery in addition to septorhinoplasty
- •Age > 80 or <18
- •Any underlying chronic pain condition or ongoing opioid use over the preceding 3 months
- •Presence of any other factor which, at the discretion of any member of the study team, makes the patient a poor candidate for block placement.
- •Presence of any other factor which, at the discretion of any member of the study team, makes the patient a poor candidate for research participation.
- •Pregnant women
研究组 & 干预措施
Group 2: Placebo plus Dexamethasone
In group 2 the same procedure will be performed, but the injectate will consist of 5 mL of a balanced crystalloid intravenous solution (4 ml of normal saline) plus 4 mg dexamethasone (each side). This procedure will be performed bilaterally.
干预措施: Dexamethasone (Drug)
Group 2: Placebo plus Dexamethasone
In group 2 the same procedure will be performed, but the injectate will consist of 5 mL of a balanced crystalloid intravenous solution (4 ml of normal saline) plus 4 mg dexamethasone (each side). This procedure will be performed bilaterally.
干预措施: Placebo (Drug)
Group 1: Ropivacaine plus Dexamethasone
The group 1 injection procedure will be performed as follows: after preparation of the skin using appropriate skin preparation solution and using aseptic technique, a small-gauge spinal needle will be advanced into the pterygopalatine fossa under ultrasound guidance. Once the needle is properly positioned, 0.5% ropivacaine will be administered at a dose of 20 mg plus 4 mg dexamethasone and the needle will be removed. This procedure will be performed bilaterally
干预措施: Ropivacaine (Drug)
Group 1: Ropivacaine plus Dexamethasone
The group 1 injection procedure will be performed as follows: after preparation of the skin using appropriate skin preparation solution and using aseptic technique, a small-gauge spinal needle will be advanced into the pterygopalatine fossa under ultrasound guidance. Once the needle is properly positioned, 0.5% ropivacaine will be administered at a dose of 20 mg plus 4 mg dexamethasone and the needle will be removed. This procedure will be performed bilaterally
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Decrease the opioid requirement post-operatively as assessed by providers.
时间窗: 7 days +/- 2 days
post operative period
Post Operative Pain Scores
时间窗: 5 days +/- 2 days
To assess if bilateral sphenopalatine nerve blocks can decrease post operative pain scores on a scale from 0-10, with a 0 meaning no pain and 10 meaning extreme pain. Pain scores were assessed on post operative days 1, 3 and 5.
次要结局
- Efficiency of SMS based survey for post-operative data collection.(5 days post-operatively +/- 1 day)
- Decrease in post-anesthesia care unit observation time.(60-180 minutes)
- Post Anesthesia Care Unit Duration(60-180 minutes)
- Text Message Survey Collection(5 days post-operatively +/- 1 day)