About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 19 years or older undergoing elective flap surgery for head and neck cancer
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Standard antiemetic and anesthetic protocol
Other interventionPatients receive general anesthesia maintained with sevoflurane and remifentanil. Dexamethasone 5 mg is administered intravenously 1 hour before the end of surgery.
Multimodal antiemetic and anesthetic protocol
Other interventionThe 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.
Treatment groups
Trial 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.
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.
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).
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.
Locations
Sponsors and contacts
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