Safety and Analgesic Efficacy of a Modified Auriculotemporal Nerve Block

NCT05556889 | Recruiting DMC

• 1 other identifier: TJ2021S195
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Efficacy of a modified auriculotemporal nerve blockade for patients undergoing supratentorial craniotomy
2. 2.Safety of a modified auriculotemporal nerve blockade for patients undergoing supratentorial craniotomy

Conditions

Safety and Efficacy; Scalp Nerve Block

Keywords

Auriculotemporal nerve block; Scalp nerve block; safety and efficacy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (32)

• mean arterial pressure (MAP) before anesthesia induction

  before anesthesia induction

• heart rate (HR) before anesthesia induction

  before anesthesia induction

• MAP 3 minutes after tracheal intubation

  3 minutes after tracheal intubation

• HR 3 minutes after tracheal intubation

  3 minutes after tracheal intubation

• MAP before nerve block

  before nerve block

Other Outcomes (18)

• operation time

  during surgery

• anesthesia time

  during surgery

• awakening time

  during surgery

Study Arms (2)

a modified auriculotemporal nerve blockade

EXPERIMENTAL

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

Traditional auriculotemporal nerve blockade

OTHER

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

Interventions

a modified auriculotemporal nerve blockade PROCEDURE

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.

a modified auriculotemporal nerve blockade

Traditional auriculotemporal nerve blockade PROCEDURE

Traditional auriculotemporal nerve blockade

Traditional auriculotemporal nerve blockade

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing supratentorial craniotomy under general anesthesia;
• years old;
• ASA I or II.

You may not qualify if:

• Emergency surgery;
• Be allergic to ropivacaine;
• Participating in other clinical investigation within 30 days;
• Skin infection at the puncture site;
• Patients taking analgesic drugs before surgery;
• Persons addicted to alcohol or drugs;
• Patients with severe liver and kidney dysfunction;
• Patients with coagulation disorder;
• Pregnant and lactating women;
• Patients with consciousness disorder before surgery;
• Those who have undergone neurosurgery within the last 6 months;
• Patients who were unable to understand the NRS before surgery.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

Study Officials

• feng gao

  professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Gao

CONTACT

13971587381; fgao@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: September 27, 2022
• Study Start: January 1, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Locations

CN (1)