Effect of a Multimodal Antiemetic Protocol on Postoperative Nausea and Vomiting in Patients Undergoing Flap Surgery for Head and Neck Cancer

N/ANot Yet RecruitingNCT07786155

Seoul National University Hospital72 enrolled

Overview

This prospective randomized controlled trial evaluates whether a multimodal antiemetic protocol can reduce postoperative nausea and vomiting (PONV) in patients undergoing flap surgery for head and neck cancer. Seventy-two patients will be randomized to receive either standard dexamethasone-based prophylaxis or a multimodal protocol incorporating TIVA, superficial cervical plexus block, palonosetron, dexamethasone, and acetaminophen. PONV, postoperative pain, quality of recovery, and other postoperative outcomes will be compared.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Postoperative Nausea and Vomiting

Interventions

Standard antiemetic and anesthetic protocol

Multimodal antiemetic and anesthetic protocolOTHER

The multimodal protocol consists of total intravenous anesthesia with propofol and remifentanil, ultrasound-guided superficial cervical plexus block with 10 mL of 0.75% ropivacaine, and intravenous administration of dexamethasone 5 mg, palonosetron 0.075 mg, and acetaminophen 1 g 1 hour before the end of surgery.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged 19 years or older undergoing elective flap surgery for head and neck cancer Exclusion Criteria: * Patients who do not consent to participate in the study * Patients undergoing emergency surgery * Patients with signs of inflammation (such as erythema) at the nerve block injection site * Patients with a history of hypersensitivity or adverse reactions to ropivacaine * Patients with difficulty completing questionnaires due to conditions such as dementia or delirium * Patients with severe cardiopulmonary disease * Patients with QT prolongation on preoperative ECG Patients deemed unsuitable for participation by the investigator

Outcomes

Primary Outcomes

Number of Episodes of Moderate-to-Severe Postoperative Nausea and Vomiting Requiring Rescue Antiemetics

The number of episodes of moderate-to-severe postoperative nausea and vomiting requiring rescue antiemetic medication within 3 days after surgery.

Time frame: Within 72 hours after surgery

Secondary Outcomes

Quality of Recovery (QoR-15K) Score

Quality of recovery assessed using the Korean version of the 15-item Quality of Recovery questionnaire (QoR-15K) before surgery and on postoperative days 1, 2, and 3. The QoR-15K score ranges from 0 to 150, with higher scores indicating better recovery.

Time frame: Preoperatively and on postoperative days 1, 2, and 3

Postoperative Nausea and Vomiting Severity

Severity of postoperative nausea and vomiting assessed at 24, 48, and 72 hours after surgery using a 4-point scale (0: none, 1: mild, 2: moderate, 3: severe).

Time frame: 24, 48, and 72 hours after surgery

Postoperative Pain Score

Postoperative pain assessed at 24, 48, and 72 hours after surgery using the 11-point Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain severity.

Time frame: 24, 48, and 72 hours after surgery