Safety and Analgesic Efficacy of a Modified Auriculotemporal Nerve Block

Not Applicable

Recruiting

• Conditions: Scalp Nerve Block; Safety and Efficacy
• Interventions: Procedure: Traditional auriculotemporal nerve blockade; Procedure: a modified auriculotemporal nerve blockade

• Registration Number: NCT05556889
• Lead Sponsor: Tongji Hospital

Brief Summary

1. Efficacy of a modified auriculotemporal nerve blockade for patients undergoing supratentorial craniotomy

2. Safety of a modified auriculotemporal nerve blockade for patients undergoing supratentorial craniotomy

Detailed Description

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.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-03-30
• Study First Submitted QC: 2022-09-23
• Study First Posted: 2022-09-27
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-05-31
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

1. Patients undergoing supratentorial craniotomy under general anesthesia;
2. 18-65 years old;
3. ASA I or II.

Exclusion Criteria

1. Emergency surgery;
2. Be allergic to ropivacaine;
3. Participating in other clinical investigation within 30 days;
4. Skin infection at the puncture site;
5. Patients taking analgesic drugs before surgery;
6. Persons addicted to alcohol or drugs;
7. Patients with severe liver and kidney dysfunction;
8. Patients with coagulation disorder;
9. Pregnant and lactating women;
10. Patients with consciousness disorder before surgery;
11. Those who have undergone neurosurgery within the last 6 months;
12. Patients who were unable to understand the NRS before surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional auriculotemporal nerve blockade	Traditional auriculotemporal nerve blockade	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
a modified auriculotemporal nerve blockade	a modified auriculotemporal nerve blockade	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.

Primary Outcome Measures

Name	Time	Method
numerical rating scale (NRS) score in both groups 2 hours after surgery	2 hours after supratentorial craniotomy	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.
numerical rating scale (NRS) score in both groups 8 hours after surgery	8 hours after supratentorial craniotomy	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.
numerical rating scale (NRS) score in both groups 24 hours after surgery	24 hours after supratentorial craniotomy	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.
incidence of facial paralysis in both two groups	within 24 hours after supratentorial craniotomy	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China