Safety and Analgesic Efficacy of a Modified Auriculotemporal Nerve Block

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

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

Study Overview

• Status: Recruiting
• Conditions: Safety and Efficacy; Scalp Nerve Block
• Intervention / Treatment: Procedure: a modified auriculotemporal nerve blockade; Procedure: Traditional auriculotemporal nerve blockade

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 Type: Interventional
• Enrollment (Estimated): 252
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Feng Gao; Phone Number: 86 13971587381; Email: fgao@tjh.tjmu.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital
      • Contact: Gao Feng, Doctor; Phone Number: 86 13971587381; Email: fgao@tjh.tjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Other: 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	Procedure: Traditional auriculotemporal nerve blockade; Traditional auriculotemporal nerve blockade

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
operation time	time from the time of surgery beginning until end of surgery	during surgery
anesthesia time	time from the time of anesthesia beginning until end of anesthesia	during surgery
awakening time	from the time of anesthesia end until time of patient awaken	during surgery
PACU staying time	from the time coming in PACU until the time coming out PACU	during surgery
anesthetic dosage	use dosage of anesthetic drug during operation	during operation
urine volume	urine volume during operation	during operation
bleeding volume	bleeding volume during operation	during operation
maintenance infusion rate of remifentanil	infusion rate of remifentanil for maintaining effective analgesic effect during operation	during operation
the dosage of remedial painkillers (remifentanil)	the dosage of remedial painkillers (remifentanil) during operation	during operation
the dosage of remedial perdipine	the dosage of remedial perdipine during operation	during operation
the dosage of remedial esmolol	the dosage of remedial perdipine during operation	during operation
incidence of postoperative nausea in both two groups within 24 hours	within 24 hours after supratentorial craniotomy, the investigators record the number of patients who suffer from postoperative nausea, and then calculate the incidence as: the number of patient suffering from postoperative nausea/the total number in corresponding group	within 24 hours after supratentorial craniotomy
incidence of postoperative vomiting in both two groups within 24 hours	within 24 hours after operation, the investigators record the number of patients who suffer from postoperative vomiting, and then calculate the incidence as: the number of patient suffering from postoperative vomiting/the total number in corresponding group	within 24 hours after operation
incidence of hematoma at the block point in both two groups within 24 hours	within 24 hours after operation, the investigators record the number of patients who suffer from hematoma at the block point, and then calculate the incidence as: the number of patient suffering from hematoma at the block point/the total number in corresponding group	within 24 hours after operation
incidence of infection at the block point in both two groups within 24 hours	within 24 hours after operation, the investigators record the number of patients who suffer from infection at the block point, and then calculate the incidence as: the number of patient suffering from infection at the block point/the total number in corresponding group	within 24 hours after operation
incidence of local anesthetic toxicity in both two groups within 24 hours	within 24 hours after operation, the investigators record the number of patients who suffer from local anesthetic toxicity, and then calculate the incidence as: the number of patient suffering from local anesthetic toxicity/the total number in corresponding group	within 24 hours after operation
the time of initial administration of remedial antiemetics within 24 hours	the time of initial administration of remedial antiemetics within 24 hours after operation	within 24 hours after operation
the dosage of remedial antiemetics within 24 hours	the dosage of remedial antiemetics within 24 hours after operation	within 24 hours after operation

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Principal Investigator: feng gao, Professor

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: September 23, 2022
• First Posted (Actual): September 27, 2022

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: safety and efficacy; Scalp nerve block; Auriculotemporal nerve block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Trace Elements; Micronutrients; Iodine
• Other Study ID Numbers: TJ2021S195

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No