Safety and Efficacy, Scalp Nerve Block
Conditions
Keywords
Auriculotemporal nerve block, Scalp nerve block, safety and efficacy
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.
Interventions
PROCEDUREa 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.
PROCEDURETraditional auriculotemporal nerve blockade
Traditional auriculotemporal nerve blockade
Sponsors
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HR 1 hour after temporal region skin incision | 1 hour after temporal region skin incision | HR 1 hour 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 4 minutes after temporal region skin incision | 4 minutes after temporal region skin incision | MAP 4 minutes after temporal region skin incision |
| HR 4 minutes after temporal region skin incision | 4 minutes after temporal region skin incision | HR 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 5 minutes after temporal region skin incision | 5 minutes after temporal region skin incision | HR 5 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 |
| MAP 20 minutes after temporal region skin incision | 20 minutes after temporal region skin incision | MAP 20 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 30 minutes after temporal region skin incision | 30 minutes after temporal region skin incision | MAP 30 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 |
| 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 |
| 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 |
| 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 during surgery (at tracheal extubation) | during surgery (at tracheal extubation) | HR during surgery (at tracheal extubation) |
| mean arterial pressure (MAP) before anesthesia induction | before anesthesia induction | MAP before anesthesia induction |
| heart rate (HR) before anesthesia induction | before anesthesia induction | HR before anesthesia induction |
| MAP 3 minutes after tracheal intubation | 3 minutes after tracheal intubation | MAP 3 minutes after tracheal intubation |
| HR 3 minutes after tracheal intubation | 3 minutes after tracheal intubation | HR 3 minutes after tracheal intubation |
| MAP before nerve block | before nerve block | MAP before nerve block |
| HR before nerve block | before nerve block | HR before nerve block |
| MAP within 10 minutes after nerve block | within 10 minutes after nerve block | MAP within 10 minutes after nerve block |
| HR within 10 minutes after nerve block | within 10 minutes after nerve block | HR within 10 minutes after nerve block |
| MAP 1 minute after temporal region skin incision | 1 minute after temporal region skin incision | MAP 1 minute after temporal region skin incision |
| HR 1 minute after temporal region skin incision | 1 minute after temporal region skin incision | HR 1 minute after temporal region skin incision |
| MAP 2 minutes after temporal region skin incision | 2 minutes after temporal region skin incision | MAP 2 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 |
| MAP 3 minutes after temporal region skin incision | 3 minutes after temporal region skin incision | MAP 3 minutes after temporal region skin incision |
Other
| Measure | Time frame | Description |
|---|---|---|
| operation time | during surgery | time from the time of surgery beginning until end of surgery |
| anesthesia time | during surgery | time from the time of anesthesia beginning until end of anesthesia |
| maintenance infusion rate of remifentanil | during operation | infusion rate of remifentanil for maintaining effective analgesic effect during operation |
| the dosage of remedial painkillers (remifentanil) | during operation | the dosage of remedial painkillers (remifentanil) during operation |
| the dosage of remedial perdipine | during operation | the dosage of remedial perdipine during operation |
| the dosage of remedial esmolol | during operation | the dosage of remedial perdipine during operation |
| incidence of postoperative nausea in both two groups within 24 hours | within 24 hours after supratentorial craniotomy | 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 |
| incidence of postoperative vomiting in both two groups within 24 hours | within 24 hours after operation | 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 |
| incidence of hematoma at the block point in both two groups within 24 hours | within 24 hours after operation | 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 |
| incidence of infection at the block point in both two groups within 24 hours | within 24 hours after operation | 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 |
| incidence of local anesthetic toxicity in both two groups within 24 hours | within 24 hours after operation | 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 |
| the time of initial administration of remedial antiemetics within 24 hours | within 24 hours after operation | the time of initial administration of remedial antiemetics within 24 hours after operation |
| the dosage of remedial antiemetics within 24 hours | within 24 hours after operation | the dosage of remedial antiemetics within 24 hours after operation |
| anesthetic dosage | during operation | use dosage of anesthetic drug during operation |
| PACU staying time | during surgery | from the time coming in PACU until the time coming out PACU |
| bleeding volume | during operation | bleeding volume during operation |
| urine volume | during operation | urine volume during operation |
| awakening time | during surgery | from the time of anesthesia end until time of patient awaken |
Countries
China
Contacts
Primary ContactFeng Gao
Outcome results
None listed