Safety and Analgesic Efficacy of a Modified Auriculotemporal Nerve Block

Tongji Hospital252 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

252

Conditions

Safety and Efficacy Scalp Nerve Block

Interventions

a modified auriculotemporal nerve blockadePROCEDURE

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 blockadePROCEDURE

Traditional auriculotemporal nerve blockade

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tongji Hospital

Wuhan, Hubei, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: within 24 hours after supratentorial craniotomy

Secondary Outcomes

mean arterial pressure (MAP) before anesthesia induction

MAP before anesthesia induction

Central Contacts

Feng Gao

CONTACT

13971587381 fgao@tjh.tjmu.edu.cn

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: before anesthesia induction

heart rate (HR) before anesthesia induction

HR before anesthesia induction

Time frame: before anesthesia induction

MAP 3 minutes after tracheal intubation

Time frame: 3 minutes after tracheal intubation

HR 3 minutes after tracheal intubation

Time frame: 3 minutes after tracheal intubation

MAP before nerve block

Time frame: before nerve block

HR before nerve block

Time frame: before nerve block

MAP within 10 minutes after nerve block

Time frame: within 10 minutes after nerve block

HR within 10 minutes after nerve block

Time frame: within 10 minutes after nerve block

MAP 1 minute after temporal region skin incision

Time frame: 1 minute after temporal region skin incision

HR 1 minute after temporal region skin incision

Time frame: 1 minute after temporal region skin incision

MAP 2 minutes after temporal region skin incision

Time frame: 2 minutes after temporal region skin incision

HR 2 minutes after temporal region skin incision

Time frame: 2 minutes after temporal region skin incision

MAP 3 minutes after temporal region skin incision

Time frame: 3 minutes after temporal region skin incision

HR 3 minutes after temporal region skin incision

Time frame: 3 minutes after temporal region skin incision

MAP 4 minutes after temporal region skin incision

Time frame: 4 minutes after temporal region skin incision

HR 4 minutes after temporal region skin incision

Time frame: 4 minutes after temporal region skin incision

MAP 5 minutes after temporal region skin incision

Time frame: 5 minutes after temporal region skin incision

HR 5 minutes after temporal region skin incision

Time frame: 5 minutes after temporal region skin incision

MAP 10 minutes after temporal region skin incision

Time frame: 10 minutes after temporal region skin incision

HR 10 minutes after temporal region skin incision

Time frame: 10 minutes after temporal region skin incision

MAP 20 minutes after temporal region skin incision

Time frame: 20 minutes after temporal region skin incision

HR 20 minutes after temporal region skin incision

Time frame: 20 minutes after temporal region skin incision

MAP 30 minutes after temporal region skin incision

Time frame: 30 minutes after temporal region skin incision

HR 30 minutes after temporal region skin incision

Time frame: 30 minutes after temporal region skin incision

MAP 40 minutes after temporal region skin incision

Time frame: 40 minutes after temporal region skin incision

HR 40 minutes after temporal region skin incision

Time frame: 40 minutes after temporal region skin incision

MAP 50 minutes after temporal region skin incision

Time frame: 50 minutes after temporal region skin incision

HR 50 minutes after temporal region skin incision

Time frame: 50 minutes after temporal region skin incision

MAP 1 hour after temporal region skin incision

Time frame: 1 hour after temporal region skin incision

HR 1 hour after temporal region skin incision

Time frame: 1 hour after temporal region skin incision

MAP during surgery (at tracheal extubation)

Time frame: during surgery (at tracheal extubation)

HR during surgery (at tracheal extubation)

Time frame: during surgery (at tracheal extubation)