Clinical trial NCT05556889: Safety and Analgesic Efficacy of a Modified Auriculotemporal Nerve Block
Official title: Safety and Analgesic Efficacy of a Modified Auriculotemporal Nerve Block: a Prospective, Randomized, Double-blind, Traditional Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Safety and Efficacy
Scalp Nerve Block
Keywords: Auriculotemporal nerve block
Scalp nerve block
safety and efficacy
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: numerical rating scale (NRS) score in both groups 2 hours after surgery
timeFrame: 2 hours after supratentorial craniotomy
measure: numerical rating scale (NRS) score in both groups 8 hours after surgery
timeFrame: 8 hours after supratentorial craniotomy
measure: numerical rating scale (NRS) score in both groups 24 hours after surgery
timeFrame: 24 hours after supratentorial craniotomy
measure: incidence of facial paralysis in both two groups
timeFrame: within 24 hours after supratentorial craniotomy
Secondary outcomes:
measure: mean arterial pressure (MAP) before anesthesia induction
timeFrame: before anesthesia induction
measure: heart rate (HR) before anesthesia induction
timeFrame: before anesthesia induction
measure: MAP 3 minutes after tracheal intubation
timeFrame: 3 minutes after tracheal intubation
measure: HR 3 minutes after tracheal intubation
timeFrame: 3 minutes after tracheal intubation
measure: MAP before nerve block
timeFrame: before nerve block
measure: HR before nerve block
timeFrame: before nerve block
measure: MAP within 10 minutes after nerve block
timeFrame: within 10 minutes after nerve block
measure: HR within 10 minutes after nerve block
timeFrame: within 10 minutes after nerve block
measure: MAP 1 minute after temporal region skin incision
timeFrame: 1 minute after temporal region skin incision
measure: HR 1 minute after temporal region skin incision
timeFrame: 1 minute after temporal region skin incision
measure: MAP 2 minutes after temporal region skin incision
timeFrame: 2 minutes after temporal region skin incision
measure: HR 2 minutes after temporal region skin incision
timeFrame: 2 minutes after temporal region skin incision
measure: MAP 3 minutes after temporal region skin incision
timeFrame: 3 minutes after temporal region skin incision
measure: HR 3 minutes after temporal region skin incision
timeFrame: 3 minutes after temporal region skin incision
measure: MAP 4 minutes after temporal region skin incision
timeFrame: 4 minutes after temporal region skin incision
measure: HR 4 minutes after temporal region skin incision
timeFrame: 4 minutes after temporal region skin incision
measure: MAP 5 minutes after temporal region skin incision
timeFrame: 5 minutes after temporal region skin incision
measure: HR 5 minutes after temporal region skin incision
timeFrame: 5 minutes after temporal region skin incision
measure: MAP 10 minutes after temporal region skin incision
timeFrame: 10 minutes after temporal region skin incision
measure: HR 10 minutes after temporal region skin incision
timeFrame: 10 minutes after temporal region skin incision
measure: MAP 20 minutes after temporal region skin incision
timeFrame: 20 minutes after temporal region skin incision
measure: HR 20 minutes after temporal region skin incision
timeFrame: 20 minutes after temporal region skin incision
measure: MAP 30 minutes after temporal region skin incision
timeFrame: 30 minutes after temporal region skin incision
measure: HR 30 minutes after temporal region skin incision
timeFrame: 30 minutes after temporal region skin incision
measure: MAP 40 minutes after temporal region skin incision
timeFrame: 40 minutes after temporal region skin incision
measure: HR 40 minutes after temporal region skin incision
timeFrame: 40 minutes after temporal region skin incision
measure: MAP 50 minutes after temporal region skin incision
timeFrame: 50 minutes after temporal region skin incision
measure: HR 50 minutes after temporal region skin incision
timeFrame: 50 minutes after temporal region skin incision
measure: MAP 1 hour after temporal region skin incision
timeFrame: 1 hour after temporal region skin incision
measure: HR 1 hour after temporal region skin incision
timeFrame: 1 hour after temporal region skin incision
measure: MAP during surgery (at tracheal extubation)
timeFrame: during surgery (at tracheal extubation)
measure: HR during surgery (at tracheal extubation)
timeFrame: during surgery (at tracheal extubation)
Other outcomes:
measure: operation time
timeFrame: during surgery
measure: anesthesia time
timeFrame: during surgery
measure: awakening time
timeFrame: during surgery
measure: PACU staying time
timeFrame: during surgery
measure: anesthetic dosage
timeFrame: during operation
measure: urine volume
timeFrame: during operation
measure: bleeding volume
timeFrame: during operation
measure: maintenance infusion rate of remifentanil
timeFrame: during operation
measure: the dosage of remedial painkillers (remifentanil)
timeFrame: during operation
measure: the dosage of remedial perdipine
timeFrame: during operation
measure: the dosage of remedial esmolol
timeFrame: during operation
measure: incidence of postoperative nausea in both two groups within 24 hours
timeFrame: within 24 hours after supratentorial craniotomy
measure: incidence of postoperative vomiting in both two groups within 24 hours
timeFrame: within 24 hours after operation
measure: incidence of hematoma at the block point in both two groups within 24 hours
timeFrame: within 24 hours after operation
measure: incidence of infection at the block point in both two groups within 24 hours
timeFrame: within 24 hours after operation
measure: incidence of local anesthetic toxicity in both two groups within 24 hours
timeFrame: within 24 hours after operation
measure: the time of initial administration of remedial antiemetics within 24 hours
timeFrame: within 24 hours after operation
measure: the dosage of remedial antiemetics within 24 hours
timeFrame: within 24 hours after operation
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: professor
name: feng gao
role: PRINCIPAL_INVESTIGATOR
References: