The Efficacy of Superficial Cervical Block Application in Postoperative Analgesia Management in Patients Undergoing Total Laryngectomy and Bilateral Neck Dissection

NCT06852651 | Completed

• 1 other identifier: Superficial Cervical Block
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the efficacy of the superficial cervical block in postoperative pain management for patients undergoing total laryngectomy and bilateral neck dissection. It will also assess its impact on recovery and clinical outcomes. The main questions it aims to answer are: Does the superficial cervical block reduce postoperative pain scores? What are the effects of the block on ventilation status, ICU stay, and hospital length of stay? Researchers will compare patients who receive the superficial cervical block to those who do not, assessing its effectiveness in pain management and postoperative recovery. Participants will: Receive a superficial cervical block or standard pain management during surgery Have their pain levels assessed using the Numeric Rating Scale (NRS) at 30 min, 4, 8, and 24 hours postoperatively Have their postoperative ventilation status, ICU stay, hospital length of stay, and complications recorded

Conditions

Laryngeal Neoplasm

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Scores (NRS)

  Pain will be assessed using the Numeric Rating Scale (NRS, 0-10) at predefined time points.

  30 minutes, 4 hours, 8 hours, and 24 hours postoperatively

Secondary Outcomes (2)

• Postoperative Opioid Consumption

  1 day

• Cough Severity Score

  30 minutes, 4 hours, 8 hours, and 24 hours postoperatively

Study Arms (2)

Superficial Cervical Block (SCB) Group

EXPERIMENTAL

Patients undergoing total laryngectomy and bilateral neck dissection who receive a superficial cervical block (SCB) for postoperative pain management. The block will be performed bilaterally under ultrasound guidance using 0.1 mL/kg of 0.25% bupivacaine after anesthesia induction. Postoperative pain scores, opioid consumption, ventilation status, ICU and hospital length of stay, and complications will be recorded.

Procedure: Superficial Cervical Block (SCB) Group

Control Group (No Block)

NO INTERVENTION

Patients undergoing total laryngectomy and bilateral neck dissection who receive standard postoperative analgesia without a superficial cervical block (SCB). Postoperative pain management will consist of intravenous analgesics as per institutional protocols. The same postoperative parameters (pain scores, opioid use, ventilation status, ICU/hospital stay, and complications) will be assessed for comparison.

Interventions

Superficial Cervical Block (SCB) Group PROCEDURE

Patients in this group will receive a bilateral superficial cervical block under ultrasound guidance after anesthesia induction but before the surgical procedure begins. The block will be performed using 0.1 mL/kg of 0.25% bupivacaine per side, targeting the superficial branches of the cervical plexus. The primary goal is to assess its efficacy in postoperative pain management and its impact on recovery parameters.

Superficial Cervical Block (SCB) Group

Eligibility Criteria

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

You may qualify if:

• Patients scheduled for total laryngectomy with bilateral neck dissection.
• Age ≥18 years.
• ASA (American Society of Anesthesiologists) classification I-IV.
• Patients who provide written informed consent.

You may not qualify if:

• Patients undergoing emergency surgery.
• Patients with known allergies to local anesthetics (e.g., bupivacaine, lidocaine).
• Patients with coagulopathy or bleeding disorders that contraindicate regional anesthesia.
• Patients with severe cognitive impairment affecting informed consent.
• Patients with infection at the injection site preventing SCB administration.

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Basaksehir cam and sakura city hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Laryngeal Neoplasms

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Postoperative pain assessments (NRS scores at 30 min, 4 h, 8 h, and 24 h), opioid consumption, and recovery outcomes will be recorded by an independent investigator who is unaware of the intervention status to reduce observer bias. Data Analyst Masking: The data will be analyzed by a statistician who is blinded to the group assignments to prevent bias in statistical interpretation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 28, 2025
• Study Start: March 10, 2025
• Primary Completion: July 10, 2025
• Study Completion: July 12, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

TU (1)