The Effect of Bilateral Infraorbital and Infratrochlear Nerve Block on Perioperative Analgesia After Endoscopic Binostril Transnasal Transsphenoidal Resection of Pituitary: a Prospective, Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- HR before septum resection
研究概览
简要总结
The endoscopic binostril transnasal transsphenoidal resection of pituitary procedures often cause intense pain which is difficult to suppress at the depth of conventional general anesthesia, resulting in severe hemodynamic fluctuations in patients. Infraorbital and infratrochlear nerve block can block the pain signal caused by the endoscopic binostril transnasal transsphenoidal resection of pituitary theoretically, which has been proven to provide satisfactory analgesia after septorhinoplasty. However, whether bilateral infraorbital and infratrochlear nerve block can provide stable hemodynamics and reduce the hemodynamic fluctuation the patients undergoing endoscopic binostril transnasal transsphenoidal resection of pituitary remains unclear.
详细描述
Surgical stimulation is one of the important factors leading to hemodynamic fluctuation and affecting postoperative recovery quality. The endoscopic binostril transnasal transsphenoidal resection of pituitary procedures often cause intense pain because of there were numerous nerve endings at the surgical site which is originated from branches of the trigeminal nerve (including infraorbital and infratrochlear nerve). It's difficult to suppress intraoperative stimulation at the depth of conventional general anesthesia, resulting in severe hemodynamic fluctuations in patients. It's reported that pterygomaxillary fossa block can inhibit hypertension caused by surgical procedures, however the block may cause complications because of its complicated operations. Infraorbital and infratrochlear nerve block can block the pain signal caused by the endoscopic binostril transnasal transsphenoidal resection of pituitary theoretically, which has been proven to provide satisfactory analgesia after septorhinoplasty. However, whether bilateral infraorbital and infratrochlear nerve block can reduce the pain in the patients undergoing endoscopic binostril transnasal transsphenoidal resection of pituitary remains unclear. Therefore, the investigators propose the hypothesis that preoperative bilateral infraorbital and infratrochlear nerve block could effectively reduce the pain in patients undergoing endoscopic binostril transnasal transsphenoidal resection of pituitary. The objective of this study is to observe the heart rate and blood pressure at a specific point in time during the operation and pain at 2, 8, 24, 48 hours postoperatively between adult patients receiving or not receiving bilateral infraorbital and infratrochlear nerve block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The patients were randomly assigned to one of two groups by a single nurse, who was not involved in the anesthetic management of the patient, while using a computer-generated randomization sequence with random block sizes of two and four. The same nurse prepared syringes containing the nerve block solution. Syringes for the block group (Block group) were filled with 6 mL of 0.5% ropivacaine. The patient, surgeon,and investigator were all blinded to the study and the adequacy of the block.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective endoscopic binostril transnasal transsphenoidal resection
- •Patients aged between 18 and
- •American Society of Anesthesiologists (ASA) physical status I, Ⅱ and III
排除标准
- •Emergency operation.
- •Patients allergic to ropivacaine.
- •Infection nearby the puncture point.
- •Patients with preoperative usage of sedative and analgesic drugs with history of alcohol abuse.
- •Patient with renal insufficiency or hepatic failure.
- •Patients who have undergone craniotomy in the recent 6 months.
- •Pregnant or lactating women, being participating in other studies.
- •Patients unable to cooperate.
研究组 & 干预措施
Nerve Block Group
Thirty minutes prior to surgery the patients received bilateral infraorbital and infratrochlear nerve block. Infraorbital nerve block was performed while using an extraoral approach. A 25 gauge needle was inserted laterally to the ipsilateral nostril after palpating the infraorbital ridge to locate the infraorbital foramen. The index finger of the non-dominant hand was positioned above the infraorbital foramen, and the needle was advanced until it was felt beneath the finger. 2 mL of the 0.5% ropivacaine slowly injected after negative aspiration of blood was confirmed. Inserting the needle 1 cm above the inner canthus, targeting the junction of the orbit and the nasal bone, performed Infratrochlear nerve block. After negative aspiration of blood, 1 mL of the 0.5% ropivacaine was injected. Contralateral nerve block was performed in the same manner.
干预措施: nerve block with 0.5% ropivacaine (Drug)
Control Group
Patients receiving general anesthesia without Infraorbital and Infratrochlear nerve block.
干预措施: without any nerve block (Other)
结局指标
主要结局
HR before septum resection
时间窗: before septum resection
HR before septum resection
heat rate (HR) before nerve block
时间窗: before nerve block
heat rate (HR) before nerve block
MAP immediately after nasal mucosal dissection
时间窗: immediately after nasal mucosal dissection
MAP immediately after nasal mucosal dissection
HR immediately after septum resection
时间窗: immediately after septum resection
HR immediately after septum resection
MAP before sella bone resection
时间窗: before sella bone resection
MAP before sella bone resection
HR before exploration of pituitary fossa
时间窗: before exploration of pituitary fossa
HR before exploration of pituitary fossa
MAP within 10 minutes after nerve block
时间窗: within 10 minutes after nerve block
MAP within 10 minutes after nerve block
HR within 10 minutes after nerve block
时间窗: within 10 minutes after nerve block
HR within 10 minutes after nerve block
HR before nasal mucosal dissection
时间窗: before nasal mucosal dissection
HR before nasal mucosal dissection
HR immediately after nasal mucosal dissection
时间窗: immediately after nasal mucosal dissection
HR immediately after nasal mucosal dissection
HR immediately after dural incision of sella
时间窗: immediately after dural incision of sella
HR immediately after dural incision of sella
mean arterial pressure (MAP) before nerve block
时间窗: before nerve block
mean arterial pressure (MAP) before nerve block
MAP before nasal mucosal dissection
时间窗: before nasal mucosal dissection
MAP before nasal mucosal dissection
MAP immediately after septum resection
时间窗: immediately after septum resection
MAP immediately after septum resection
HR before sella bone resection
时间窗: before sella bone resection
HR before sella bone resection
MAP after sella bone resection
时间窗: before sella bone resection
MAP after sella bone resection
MAP before dural incision of sella
时间窗: before dural incision of sella
MAP before dural incision of sella
MAP before exploration of pituitary fossa
时间窗: before exploration of pituitary fossa
MAP before exploration of pituitary fossa
MAP before septum resection
时间窗: before septum resection
MAP before septum resection
HR immediately after sella bone resection
时间窗: immediately after sella bone resection
HR immediately after sella bone resection
HR before dural incision of sella
时间窗: before dural incision of sella
HR before dural incision of sella
MAP immediately after dural incision of sella
时间窗: immediately after dural incision of sella
MAP immediately after dural incision of sella
MAP immediately after exploration of pituitary fossa
时间窗: immediately after exploration of pituitary fossa
MAP immediately after exploration of pituitary fossa
HR immediately after exploration of pituitary fossa
时间窗: immediately after exploration of pituitary fossa
HR immediately after exploration of pituitary fossa
次要结局
- numerical rating scale (NRS) score before patient leaves PACU(before patient leaves PACU)
- NRS 24 hours after surgery(24 hours after surgery)
- NRS 2 hours after surgery(2 hours after surgery)
- NRS 8 hours after surgery(8 hours after surgery)
- quality of recovery Scale: Quality of Recovery-15 (QoR-15) 1 day after surgery(1 day after surgery)
- quality of recovery Scale: QoR-15 3 days after surgery(3 days after surgery)
- NRS 48 hours after surgery(48 hours after surgery)
- numerical rating scale (NRS) score when patient enters post-anaesthesia care unit (PACU) (immediately after surgery)(when patient enters PACU (immediately after surgery))
- quality of recovery Scale: QoR-15 7 days after surgery(7 days after surgery)