Safety and Analgesic Efficacy of a Modified Auriculotemporal Nerve Block

Safety and Efficacy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05556889
• Other study ID #: TJ2021S195
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: Tongji Hospital
• Contact: Feng Gao
• Phone: 13971587381
• Email: fgao[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 252
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Safety and Efficacy

Intervention

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.
• Traditional auriculotemporal nerve blockade
Traditional auriculotemporal nerve blockade

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	operation time	time from the time of surgery beginning until end of surgery	during surgery
Other	anesthesia time	time from the time of anesthesia beginning until end of anesthesia	during surgery
Other	awakening time	from the time of anesthesia end until time of patient awaken	during surgery
Other	PACU staying time	from the time coming in PACU until the time coming out PACU	during surgery
Other	anesthetic dosage	use dosage of anesthetic drug during operation	during operation
Other	urine volume	urine volume during operation	during operation
Other	bleeding volume	bleeding volume during operation	during operation
Other	maintenance infusion rate of remifentanil	infusion rate of remifentanil for maintaining effective analgesic effect during operation	during operation
Other	the dosage of remedial painkillers (remifentanil)	the dosage of remedial painkillers (remifentanil) during operation	during operation
Other	the dosage of remedial perdipine	the dosage of remedial perdipine during operation	during operation
Other	the dosage of remedial esmolol	the dosage of remedial perdipine during operation	during operation
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	the dosage of remedial antiemetics within 24 hours	the dosage of remedial antiemetics within 24 hours after operation	within 24 hours after operation
Primary	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
Primary	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
Primary	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
Primary	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	mean arterial pressure (MAP) before anesthesia induction	MAP before anesthesia induction	before anesthesia induction
Secondary	heart rate (HR) before anesthesia induction	HR before anesthesia induction	before anesthesia induction
Secondary	MAP 3 minutes after tracheal intubation	MAP 3 minutes after tracheal intubation	3 minutes after tracheal intubation
Secondary	HR 3 minutes after tracheal intubation	HR 3 minutes after tracheal intubation	3 minutes after tracheal intubation
Secondary	MAP before nerve block	MAP before nerve block	before nerve block
Secondary	HR before nerve block	HR before nerve block	before nerve block
Secondary	MAP within 10 minutes after nerve block	MAP within 10 minutes after nerve block	within 10 minutes after nerve block
Secondary	HR within 10 minutes after nerve block	HR within 10 minutes after nerve block	within 10 minutes after nerve block
Secondary	MAP 1 minute after temporal region skin incision	MAP 1 minute after temporal region skin incision	1 minute after temporal region skin incision
Secondary	HR 1 minute after temporal region skin incision	HR 1 minute after temporal region skin incision	1 minute after temporal region skin incision
Secondary	MAP 2 minutes after temporal region skin incision	MAP 2 minutes after temporal region skin incision	2 minutes after temporal region skin incision
Secondary	HR 2 minutes after temporal region skin incision	HR 2 minutes after temporal region skin incision	2 minutes after temporal region skin incision
Secondary	MAP 3 minutes after temporal region skin incision	MAP 3 minutes after temporal region skin incision	3 minutes after temporal region skin incision
Secondary	HR 3 minutes after temporal region skin incision	HR 3 minutes after temporal region skin incision	3 minutes after temporal region skin incision
Secondary	MAP 4 minutes after temporal region skin incision	MAP 4 minutes after temporal region skin incision	4 minutes after temporal region skin incision
Secondary	HR 4 minutes after temporal region skin incision	HR 4 minutes after temporal region skin incision	4 minutes after temporal region skin incision
Secondary	MAP 5 minutes after temporal region skin incision	MAP 5 minutes after temporal region skin incision	5 minutes after temporal region skin incision
Secondary	HR 5 minutes after temporal region skin incision	HR 5 minutes after temporal region skin incision	5 minutes after temporal region skin incision
Secondary	MAP 10 minutes after temporal region skin incision	MAP 10 minutes after temporal region skin incision	10 minutes after temporal region skin incision
Secondary	HR 10 minutes after temporal region skin incision	HR 10 minutes after temporal region skin incision	10 minutes after temporal region skin incision
Secondary	MAP 20 minutes after temporal region skin incision	MAP 20 minutes after temporal region skin incision	20 minutes after temporal region skin incision
Secondary	HR 20 minutes after temporal region skin incision	HR 20 minutes after temporal region skin incision	20 minutes after temporal region skin incision
Secondary	MAP 30 minutes after temporal region skin incision	MAP 30 minutes after temporal region skin incision	30 minutes after temporal region skin incision
Secondary	HR 30 minutes after temporal region skin incision	HR 30 minutes after temporal region skin incision	30 minutes after temporal region skin incision
Secondary	MAP 40 minutes after temporal region skin incision	MAP 40 minutes after temporal region skin incision	40 minutes after temporal region skin incision
Secondary	HR 40 minutes after temporal region skin incision	HR 40 minutes after temporal region skin incision	40 minutes after temporal region skin incision
Secondary	MAP 50 minutes after temporal region skin incision	MAP 50 minutes after temporal region skin incision	50 minutes after temporal region skin incision
Secondary	HR 50 minutes after temporal region skin incision	HR 50 minutes after temporal region skin incision	50 minutes after temporal region skin incision
Secondary	MAP 1 hour after temporal region skin incision	MAP 1 hour after temporal region skin incision	1 hour after temporal region skin incision
Secondary	HR 1 hour after temporal region skin incision	HR 1 hour after temporal region skin incision	1 hour after temporal region skin incision
Secondary	MAP during surgery (at tracheal extubation)	MAP during surgery (at tracheal extubation)	during surgery (at tracheal extubation)
Secondary	HR during surgery (at tracheal extubation)	HR during surgery (at tracheal extubation)	during surgery (at tracheal extubation)