Analgesic effects of ultrasound-guided maxillary nerve block for tonsillectomy: a prospective randomized, double-blind, placebo-controlled trial

JRCT ID: jRCT1011210003

Registered date:27/04/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: tonsillectomy
• Date of first enrollment: 08/04/2021
• Target sample size: 44
• Study type: Interventional
• Intervention(s): The QoR-40 test is administered to all patients preoperatively, and they are assigned to either the block group or the placebo control group randomly by computer. The allocation supervisor hands an envelope with the results of each group allocation to the operating room pharmacist or nurse, who opens the envelope and fills the syringe with 0.375% ropivacaine or saline according to the results. After induction of general anesthesia and tracheal intubation, ultrasound-guided maxillary nerve blocks are performed, and 5 mL of the syringe-filled drug is administered bilaterally.

Outcome(s)

• Primary Outcome: rest visual analog scale (VAS) at returning the ward, 2hr, 4hr, 8hr, 24hr after the returning

Secondary Outcome

swallowing visual analog scale (VAS) at returning the ward, 2hr, 4hr, 8hr, 24hr after the returning
Fentanyl consumption and rescue frequency from extubation to 24 hours postoperatively
Quality of recovery score (QoR-40) at 24 hours postoperatively
Intraoperative remifentanil use
Time from discharge to first rescue administration
Time to start postoperative drinking water
Time to start postoperative drinking and food intake
Incidence of adverse events (local anesthetic poisoning, hematoma formation, local infection, postoperative nausea and vomiting due to nerve block, and hypoxia)
Hypoxic events (SpO2<92%, airway-related adverse events requiring tracheal intubation and ventilatory management)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

over 18 years of age
ASA-PS I to III
undergoing tonsillectomy

• Exclude criteria: Patients who are allergic to the study drug, blood coagulation disorders, chronic opioid use, supected peripheral neuropathy (e.g., severe diabetes mellitus), pregnancy, mental disorders, patients who were not extubated in the operating room after surgery for some reason, and other patients who, at the discretion of the physician in charge, are considered inappropriate for this study.

Related Information

• Primary Sponsor: Chaki Tomohiro
• Secondary Sponsor: Yamakage Michiaki