The Effect of Bilateral Infraorbital and Infratrochlear Nerve Block on Perioperative Period of Hypophysectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Bilateral Infraorbital and Infratrochlear Nerve Block on Perioperative Analgesia After Endoscopic Binostril Transnasal Transsphenoidal Resection of Pituitary: a Prospective, Randomized Study

Conditions
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Pain, Nerve Block

Intervention / Treatment
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* Drug: nerve block with 0.5% ropivacaine
* Other: without any nerve block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Elective endoscopic binostril transnasal transsphenoidal resection 2. Patients aged between 18 and 65. 3. American Society of Anesthesiologists (ASA) physical status I, Ⅱ and III Exclusion Criteria: 1. Emergency operation. 2. Patients allergic to ropivacaine. 3. Infection nearby the puncture point. 4. Patients with preoperative usage of sedative and analgesic drugs with history of alcohol abuse. 5. Patient with renal insufficiency or hepatic failure. 6. Patients who have undergone craniotomy in the recent 6 months. 7. Pregnant or lactating women, being participating in other studies. 8. Patients unable to cooperate.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Thirty minutes prior to surgery the patients received bilateral infraorbital and infratrochlear nerve block. The patient's head was positioned on a central line in the supine position. 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 study solution was 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 study solution was injected. Contralateral nerve block was performed in the same manner.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nerve Block Group<br>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. | Drug: nerve block with 0.5% ropivacaine<br>* After general anesthesia, the patients will receive bilateral infraorbital and infratrochlear nerve block 30 minutes prior to surgery. Infraorbital nerve block is 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.<br>|
| Sham Comparator: Control Group<br>Patients receiving general anesthesia without Infraorbital and Infratrochlear nerve block. | Other: without any nerve block<br>* Patients receiving general anesthesia without Infraorbital and Infratrochlear nerve block.<br>* Other names: nerve block with 0.5% ropivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean arterial pressure (MAP) before nerve block | mean arterial pressure (MAP) before nerve block | before nerve block | 
| heat rate (HR) before nerve block | heat rate (HR) before nerve block | before nerve block | 
| MAP within 10 minutes after nerve block | MAP within 10 minutes after nerve block | within 10 minutes after nerve block | 
| HR within 10 minutes after nerve block | HR within 10 minutes after nerve block | within 10 minutes after nerve block | 
| MAP before nasal mucosal dissection | MAP before nasal mucosal dissection | before nasal mucosal dissection | 
| HR before nasal mucosal dissection | HR before nasal mucosal dissection | before nasal mucosal dissection | 
| MAP immediately after nasal mucosal dissection | MAP immediately after nasal mucosal dissection | immediately after nasal mucosal dissection | 
| HR immediately after nasal mucosal dissection | HR immediately after nasal mucosal dissection | immediately after nasal mucosal dissection | 
| MAP before septum resection | MAP before septum resection | before septum resection | 
| HR before septum resection | HR before septum resection | before septum resection | 
| MAP immediately after septum resection | MAP immediately after septum resection | immediately after septum resection | 
| HR immediately after septum resection | HR immediately after septum resection | immediately after septum resection | 
| MAP before sella bone resection | MAP before sella bone resection | before sella bone resection | 
| HR before sella bone resection | HR before sella bone resection | before sella bone resection | 
| MAP after sella bone resection | MAP after sella bone resection | before sella bone resection | 
| HR immediately after sella bone resection | HR immediately after sella bone resection | immediately after sella bone resection | 
| MAP before dural incision of sella | MAP before dural incision of sella | before dural incision of sella | 
| HR before dural incision of sella | HR before dural incision of sella | before dural incision of sella | 
| MAP immediately after dural incision of sella | MAP immediately after dural incision of sella | immediately after dural incision of sella | 
| HR immediately after dural incision of sella | HR immediately after dural incision of sella | immediately after dural incision of sella | 
| MAP before exploration of pituitary fossa | MAP before exploration of pituitary fossa | before exploration of pituitary fossa | 
| HR before exploration of pituitary fossa | HR before exploration of pituitary fossa | before exploration of pituitary fossa | 
| MAP immediately after exploration of pituitary fossa | MAP immediately after exploration of pituitary fossa | immediately after exploration of pituitary fossa | 
| HR immediately after exploration of pituitary fossa | HR immediately after exploration of pituitary fossa | immediately after exploration of pituitary fossa | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numerical rating scale (NRS) score when patient enters post-anaesthesia care unit (PACU) (immediately after surgery) | numerical rating scale (NRS) score when patient enters PACU (immediately after surgery). The participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method. | when patient enters PACU (immediately after surgery) | 
| numerical rating scale (NRS) score before patient leaves PACU | numerical rating scale (NRS) score before patient leaves PACU. The participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method. | before patient leaves PACU | 
| NRS 2 hours after surgery | NRS 2 hours after surgery. The participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method. | 2 hours after surgery | 
| NRS 8 hours after surgery | NRS 8 hours after surgery. The participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method. | 8 hours after surgery | 
| NRS 24 hours after surgery | NRS 24 hours after surgery. The participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method. | 24 hours after surgery | 
| NRS 48 hours after surgery | NRS 48 hours after surgery. The participants subjectively determine the patient's pain scores using a 0 to 10 NRS (0 = no pain; 10 = unbearable pain), to evaluate the efficacy of the modified method. | 48 hours after surgery | 
| quality of recovery Scale: Quality of Recovery-15 (QoR-15) 1 day after surgery | quality of recovery Scale (QoR-15): QoR-15 1 day after surgery. QoR-15 contains the five aspects (physiological comfort, physiological independence, psychological support, emotion and pain), which can evaluate postoperative recovery quality. | 1 day after surgery | 
| quality of recovery Scale: QoR-15 3 days after surgery | quality of recovery Scale: QoR-15 3 days after surgery. QoR-15 contains the five aspects (physiological comfort, physiological independence, psychological support, emotion and pain), which can evaluate postoperative recovery quality. | 3 days after surgery | 
| quality of recovery Scale: QoR-15 7 days after surgery | quality of recovery Scale: QoR-15 7 days after surgery. QoR-15 contains the five aspects (physiological comfort, physiological independence, psychological support, emotion and pain), which can evaluate postoperative recovery quality. | 7 days after surgery |