Safety and Analgesic Efficacy of a Modified Auriculotemporal Nerve Block

Study Overview
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Brief Summary
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Efficacy of a modified auriculotemporal nerve blockade for patients undergoing supratentorial craniotomy Safety of a modified auriculotemporal nerve blockade for patients undergoing supratentorial craniotomy

Detailed Description
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Scalp nerve block for supratentorial craniotomy patients can effectively reduce the consumption of perioperative analgesic drugs, avoid the occurrence of hypertension and tachycardia, relieve postoperative pain, improve postoperative recovery quality of patients. Scalp nerve block is safe and has fewer complications due to the small amount of local anesthetic. For auriculotemporal nerve block, temporary block of adjacent facial nerve is one of the most likely complications, with an incidence of 8.6%, and usually can be recovered within 24 hours, since the facial nerve was located in the anterior and lower part of the tragus, 1 cm deep in the skin. Therefore, improving nerve block methods and reducing the dosage of local anesthetics may reduce the risk of facial nerve block. The investigators proposed helix feet in front of the zygomatic arch as anatomy marks of auriculotemporal nerve block, and the modified auriculotemporal nerve blockade is implemented as follows: Zygomatic arch level, posterior to the superficial temporal artery, the vertical puncture depth is about 0.5 -1 cm, and 2 ml of local anesthetics are injected after withdrawing without blood. The study intends to compare a modified auriculotemporal nerve block method with the traditional way, reflecting on perioperative hemodynamical fluctuation, postoperative analgesia effect and incidence of facial nerve paralysis. This will verify the safety and analgesic efficacy of the modified nerve block method proposed in this study, and then provide a basis for improving the quality of perioperative management during neurosurgery.

Official Title
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Safety and Analgesic Efficacy of a Modified Auriculotemporal Nerve Block: a Prospective, Randomized, Double-blind, Traditional Controlled Study

Conditions
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Safety and Efficacy, Scalp Nerve Block

Intervention / Treatment
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* Procedure: a modified auriculotemporal nerve blockade
* Procedure: Traditional auriculotemporal nerve blockade


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing supratentorial craniotomy under general anesthesia; 18-65 years old; ASA I or II. Exclusion Criteria: Emergency surgery; Be allergic to ropivacaine; Participating in other clinical investigation within 30 days; Skin infection at the puncture site; Patients taking analgesic drugs before surgery; Persons addicted to alcohol or drugs; Patients with severe liver and kidney dysfunction; Patients with coagulation disorder; Pregnant and lactating women; Patients with consciousness disorder before surgery; Those who have undergone neurosurgery within the last 6 months; Patients who were unable to understand the NRS before surgery.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: a modified auriculotemporal nerve blockade<br>Helix feet in front of the zygomatic arch is served as anatomy marks of auriculotemporal nerve block, and the modified auriculotemporal nerve blockade is implemented as follows: Zygomatic arch level, posterior to the superficial temporal artery, the vertical puncture depth is about 0.5 -1 cm, and 2 ml of local anesthetics are injected after withdrawing without blood. | Procedure: a modified auriculotemporal nerve blockade<br>* Helix feet in front of the zygomatic arch is served as anatomy marks of auriculotemporal nerve block, and the modified auriculotemporal nerve blockade is implemented as follows: Zygomatic arch level, posterior to the superficial temporal artery, the vertical puncture depth is about 0.5 -1 cm, and 2 ml of local anesthetics are injected after withdrawing without blood.<br>|
| Other: Traditional auriculotemporal nerve blockade<br>The traditional method of auriculotemporal nerve block is to inject the needle 1 1.5 cm vertically at the level of tragus and posterior of superficial temporal artery, and inject 2-3 ml of local anesthetics after pumping back without blood | Procedure: Traditional auriculotemporal nerve blockade<br>* Traditional auriculotemporal nerve blockade<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numerical rating scale (NRS) score in both groups 2 hours after surgery | 2 hours after supratentorial craniotomy, 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 supratentorial craniotomy | 
| numerical rating scale (NRS) score in both groups 8 hours after surgery | 8 hours after supratentorial craniotomy, 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 supratentorial craniotomy | 
| numerical rating scale (NRS) score in both groups 24 hours after surgery | 24 hours after supratentorial craniotomy, 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 supratentorial craniotomy | 
| incidence of facial paralysis in both two groups | within 24 hours after supratentorial craniotomy, the investigators evaluate facial nerve function of awakened participants (Diagnostic criteria for facial paralysis: unable to raise the eyebrows on the same side, unable to frown, unable to close eyes completely, or unable to smile due to facial paralysis on the same side), and record the number of patients who suffer from facial paralysis, and then calculate the incidence as: the number of patient suffering from facial paralysis/the total number in corresponding group | within 24 hours after supratentorial craniotomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean arterial pressure (MAP) before anesthesia induction | MAP before anesthesia induction | before anesthesia induction | 
| heart rate (HR) before anesthesia induction | HR before anesthesia induction | before anesthesia induction | 
| MAP 3 minutes after tracheal intubation | MAP 3 minutes after tracheal intubation | 3 minutes after tracheal intubation | 
| HR 3 minutes after tracheal intubation | HR 3 minutes after tracheal intubation | 3 minutes after tracheal intubation | 
| MAP before nerve block | MAP before nerve block | before nerve block | 
| HR before nerve block | 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 1 minute after temporal region skin incision | MAP 1 minute after temporal region skin incision | 1 minute after temporal region skin incision | 
| HR 1 minute after temporal region skin incision | HR 1 minute after temporal region skin incision | 1 minute after temporal region skin incision | 
| MAP 2 minutes after temporal region skin incision | MAP 2 minutes after temporal region skin incision | 2 minutes after temporal region skin incision | 
| HR 2 minutes after temporal region skin incision | HR 2 minutes after temporal region skin incision | 2 minutes after temporal region skin incision | 
| MAP 3 minutes after temporal region skin incision | MAP 3 minutes after temporal region skin incision | 3 minutes after temporal region skin incision | 
| HR 3 minutes after temporal region skin incision | HR 3 minutes after temporal region skin incision | 3 minutes after temporal region skin incision | 
| MAP 4 minutes after temporal region skin incision | MAP 4 minutes after temporal region skin incision | 4 minutes after temporal region skin incision | 
| HR 4 minutes after temporal region skin incision | HR 4 minutes after temporal region skin incision | 4 minutes after temporal region skin incision | 
| MAP 5 minutes after temporal region skin incision | MAP 5 minutes after temporal region skin incision | 5 minutes after temporal region skin incision | 
| HR 5 minutes after temporal region skin incision | HR 5 minutes after temporal region skin incision | 5 minutes after temporal region skin incision | 
| MAP 10 minutes after temporal region skin incision | MAP 10 minutes after temporal region skin incision | 10 minutes after temporal region skin incision | 
| HR 10 minutes after temporal region skin incision | HR 10 minutes after temporal region skin incision | 10 minutes after temporal region skin incision | 
| MAP 20 minutes after temporal region skin incision | MAP 20 minutes after temporal region skin incision | 20 minutes after temporal region skin incision | 
| HR 20 minutes after temporal region skin incision | HR 20 minutes after temporal region skin incision | 20 minutes after temporal region skin incision | 
| MAP 30 minutes after temporal region skin incision | MAP 30 minutes after temporal region skin incision | 30 minutes after temporal region skin incision | 
| HR 30 minutes after temporal region skin incision | HR 30 minutes after temporal region skin incision | 30 minutes after temporal region skin incision | 
| MAP 40 minutes after temporal region skin incision | MAP 40 minutes after temporal region skin incision | 40 minutes after temporal region skin incision | 
| HR 40 minutes after temporal region skin incision | HR 40 minutes after temporal region skin incision | 40 minutes after temporal region skin incision | 
| MAP 50 minutes after temporal region skin incision | MAP 50 minutes after temporal region skin incision | 50 minutes after temporal region skin incision | 
| HR 50 minutes after temporal region skin incision | HR 50 minutes after temporal region skin incision | 50 minutes after temporal region skin incision | 
| MAP 1 hour after temporal region skin incision | MAP 1 hour after temporal region skin incision | 1 hour after temporal region skin incision | 
| HR 1 hour after temporal region skin incision | HR 1 hour after temporal region skin incision | 1 hour after temporal region skin incision | 
| MAP during surgery (at tracheal extubation) | MAP during surgery (at tracheal extubation) | during surgery (at tracheal extubation) | 
| HR during surgery (at tracheal extubation) | HR during surgery (at tracheal extubation) | during surgery (at tracheal extubation) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Auriculotemporal nerve block, Scalp nerve block, safety and efficacy