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NCT Number: NCT07786155

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

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.

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Key information

Conditions

Postoperative Nausea and Vomiting Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard antiemetic and anesthetic protocol

Other

Patients 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

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.

Primary outcomes

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

    Time frame: Within 72 hours after surgery

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

Secondary outcomes

  1. Quality of Recovery (QoR-15K) Score

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

    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.

  2. Postoperative Nausea and Vomiting Severity

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

    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).

  3. Postoperative Pain Score

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

    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.

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Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Effect of a Multimodal Antiemetic Protocol on Postoperative Nausea and Vomiting in Patients Undergoing Flap Surgery for Head and Neck Cancer: A Prospective Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 25, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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