Laryngeal NeoplasmNCT06852651
The Efficacy of Superficial Cervical Block Application in Postoperative Analgesia Management in Patients Undergoing Total Laryngectomy and Bilateral Neck Dissection
A study testing Superficial Cervical Block (SCB) Group in people with Laryngeal Neoplasm, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngeal Neoplasm
- What is being tested?
- Superficial Cervical Block (SCB) Group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2025to 12 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Basaksehir cam and sakura city hospital
Istanbul
About this study
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.
Read more
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
Read the detailed description
Background and Rationale:
Total laryngectomy with bilateral neck dissection is a major head and neck surgery that significantly impacts postoperative recovery and pain management. Effective analgesia is crucial in these patients to facilitate early rehabilitation, optimize respiratory function, and improve overall outcomes. Conventional postoperative pain management strategies often rely on systemic opioids, which may lead to adverse effects such as respiratory depression, nausea, and sedation, potentially delaying recovery and increasing ICU length of stay.
The superficial cervical block (SCB) is a regional anesthesia technique that provides analgesia by targeting the superficial branches of the cervical plexus. It has been shown to reduce postoperative pain in head and neck surgeries while minimizing opioid-related side effects. However, its efficacy in patients undergoing total laryngectomy with bilateral neck dissection remains understudied. This study aims to evaluate whether the addition of a superficial cervical block to standard anesthesia protocols improves postoperative pain management and enhances recovery outcomes in these patients.
Study Objectives:
The primary objective of this study is to determine the effectiveness of the superficial cervical block in reducing postoperative pain in patients undergoing total laryngectomy and bilateral neck dissection.
The secondary objectives include:
Ventilation outcomes: Assessing whether the use of SCB reduces the need for postoperative ventilatory support, including prolonged mechanical ventilation or re-intubation.
ICU admission and hospital length of stay: Evaluating if SCB contributes to shorter ICU and hospital stays by improving pain control and facilitating early mobilization.
Postoperative recovery metrics: Investigating the impact of SCB on post-extubation respiratory function, tracheostomy adaptation, and overall postoperative morbidity.
Opioid consumption: Comparing opioid requirements in patients who receive SCB versus those who do not.
Complication rates: Monitoring for any adverse effects related to SCB, including local anesthetic toxicity, hematoma, or block failure.
Study Design:
This study is designed as a prospective observational trial conducted at a tertiary care hospital. Patients scheduled for total laryngectomy with bilateral neck dissection will be enrolled after obtaining informed consent.
Patient Selection Criteria:
Inclusion Criteria:
Patients undergoing total laryngectomy and bilateral neck dissection. Aged ≥18 years. ASA classification I-IV. Patients who provide written informed consent.
Exclusion Criteria:
Patients undergoing emergency total laryngectomy. Patients with allergy to local anesthetics. Patients with coagulopathy or contraindications to regional anesthesia.
Intervention and Methodology:
All patients will undergo standardized general anesthesia with ASA monitoring, including:
Electrocardiography (ECG) Non-invasive blood pressure monitoring End-tidal CO₂ (EtCO₂) and SpO₂ monitoring Invasive arterial blood pressure monitoring (if required)
After anesthesia induction and orotracheal intubation, patients will be divided into two groups based on anesthesiologist discretion:
SCB Group: Patients will receive an ultrasound-guided superficial cervical block using 0.1 mL/kg of 0.25% bupivacaine bilaterally.
Control Group: Patients will undergo standard postoperative pain management without regional anesthesia.
Postoperative Pain and Recovery Assessments:
Pain assessment: Postoperative pain scores will be recorded using the Numeric Rating Scale (NRS, 0-10) at 30 minutes, 4 hours, 8 hours, and 24 hours postoperatively.
Cough assessment: Cough severity will be graded on a 0-4 scale at the same time points.
Postoperative ventilation status: Duration of mechanical ventilation and incidence of postoperative respiratory complications will be noted.
ICU and hospital stay duration: The total length of ICU and hospital stay will be compared between groups.
Postoperative opioid consumption: The total amount of rescue analgesics (morphine, tramadol, etc.) will be recorded.
Morbidity and mortality: Postoperative complications, including cardiovascular, pulmonary, and surgical site complications, will be documented.
Outcome Measures:
Primary Outcome:
Postoperative pain scores (NRS) at 30 min, 4 h, 8 h, and 24 h.
Secondary Outcomes:
Duration of postoperative ventilation (mechanical ventilation hours, need for reintubation).
ICU and hospital length of stay (days spent in ICU and hospital). Postoperative opioid consumption (total morphine-equivalent dose). Cough severity scores at multiple time points. Postoperative morbidity and mortality rates.
Statistical Analysis Plan:
Categorical data (e.g., ventilation status, ICU admission, mortality) will be analyzed using Chi-square or Fisher's exact test.
Continuous variables (e.g., pain scores, opioid consumption, hospital stay) will be compared using independent samples t-test or Mann-Whitney U test, depending on normality distribution.
Repeated measures analysis (ANOVA or Friedman test) will be applied to assess changes in pain and cough scores over time.
Significance and Impact of the Study:
This study will provide critical insights into the role of superficial cervical block in improving pain control and recovery outcomes in patients undergoing major head and neck surgery.
If effective, SCB may become a standardized part of perioperative pain management in these patients, reducing opioid dependence and enhancing early postoperative recovery.
Findings from this research will be disseminated through peer-reviewed journals and international conferences to contribute to the growing body of evidence supporting regional anesthesia techniques in head and neck surgery.
- Conditions
- Laryngeal Neoplasm
- Being tested
- Superficial Cervical Block (SCB) Group
- Medical subject headings
- Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superficial Cervical Block (SCB) GroupProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Scores (NRS)
Pain will be assessed using the Numeric Rating Scale (NRS, 0-10) at predefined time points.
Measured: 30 minutes, 4 hours, 8 hours, and 24 hours postoperatively
Secondary outcomes (2)
Postoperative Opioid Consumption
Total morphine-equivalent opioid usage will be recorded.
Measured: 1 day
Cough Severity Score
Cough severity will be graded on a 0-4 scale (0 = no cough, 4 = severe cough affecting recovery).
Measured: 30 minutes, 4 hours, 8 hours, and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start10 Mar 2025
- Primary completion10 Jul 2025
- Study completion12 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hilal AKCA, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852651
- Sponsor's protocol ID
- Superficial Cervical Block
- Status last verified
- Jul 2025
- First submitted
- 24 Feb 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Superficial Cervical Block Application in Postoperative Analgesia Management in Patients Undergoing Total Laryngectomy and Bilateral Neck Dissection
- ClinicalTrials.gov ID
- NCT06852651
- Acronym / sponsor ID
- Superficial Cervical Block
- Conditions
- Laryngeal Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 12 Jul 2025 (actual)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Background and Rationale:
Total laryngectomy with bilateral neck dissection is a major head and neck surgery that significantly impacts postoperative recovery and pain management. Effective analgesia is crucial in these patients to facilitate early rehabilitation, optimize respiratory function, and improve overall outcomes. Conventional postoperative pain management strategies often rely on systemic opioids, which may lead to adverse effects such as respiratory depression, nausea, and sedation, potentially delaying recovery and increasing ICU length of stay.
The superficial cervical block (SCB) is a regional anesthesia technique that provides analgesia by targeting the superficial branches of the cervical plexus. It has been shown to reduce postoperative pain in head and neck surgeries while minimizing opioid-related side effects. However, its efficacy in patients undergoing total laryngectomy with bilateral neck dissection remains understudied. This study aims to evaluate whether the addition of a superficial cervical block to standard anesthesia protocols improves postoperative pain management and enhances recovery outcomes in these patients.
Study Objectives:
The primary objective of this study is to determine the effectiveness of the superficial cervical block in reducing postoperative pain in patients undergoing total laryngectomy and bilateral neck dissection.
The secondary objectives include:
Ventilation outcomes: Assessing whether the use of SCB reduces the need for postoperative ventilatory support, including prolonged mechanical ventilation or re-intubation.
ICU admission and hospital length of stay: Evaluating if SCB contributes to shorter ICU and hospital stays by improving pain control and facilitating early mobilization.
Postoperative recovery metrics: Investigating the impact of SCB on post-extubation respiratory function, tracheostomy adaptation, and overall postoperative morbidity.
Opioid consumption: Comparing opioid requirements in patients who receive SCB versus those who do not.
Complication rates: Monitoring for any adverse effects related to SCB, including local anesthetic toxicity, hematoma, or block failure.
Study Design:
This study is designed as a prospective observational trial conducted at a tertiary care hospital. Patients scheduled for total laryngectomy with bilateral neck dissection will be enrolled after obtaining informed consent.
Patient Selection Criteria:
Inclusion Criteria:
Patients undergoing total laryngectomy and bilateral neck dissection. Aged ≥18 years. ASA classification I-IV. Patients who provide written informed consent.
Exclusion Criteria:
Patients undergoing emergency total laryngectomy. Patients with allergy to local anesthetics. Patients with coagulopathy or contraindications to regional anesthesia.
Intervention and Methodology:
All patients will undergo standardized general anesthesia with ASA monitoring, including:
Electrocardiography (ECG) Non-invasive blood pressure monitoring End-tidal CO₂ (EtCO₂) and SpO₂ monitoring Invasive arterial blood pressure monitoring (if required)
After anesthesia induction and orotracheal intubation, patients will be divided into two groups based on anesthesiologist discretion:
SCB Group: Patients will receive an ultrasound-guided superficial cervical block using 0.1 mL/kg of 0.25% bupivacaine bilaterally.
Control Group: Patients will undergo standard postoperative pain management without regional anesthesia.
Postoperative Pain and Recovery Assessments:
Pain assessment: Postoperative pain scores will be recorded using the Numeric Rating Scale (NRS, 0-10) at 30 minutes, 4 hours, 8 hours, and 24 hours postoperatively.
Cough assessment: Cough severity will be graded on a 0-4 scale at the same time points.
Postoperative ventilation status: Duration of mechanical ventilation and incidence of postoperative respiratory complications will be noted.
ICU and hospital stay duration: The total length of ICU and hospital stay will be compared between groups.
Postoperative opioid consumption: The total amount of rescue analgesics (morphine, tramadol, etc.) will be recorded.
Morbidity and mortality: Postoperative complications, including cardiovascular, pulmonary, and surgical site complications, will be documented.
Outcome Measures:
Primary Outcome:
Postoperative pain scores (NRS) at 30 min, 4 h, 8 h, and 24 h.
Secondary Outcomes:
Duration of postoperative ventilation (mechanical ventilation hours, need for reintubation).
ICU and hospital length of stay (days spent in ICU and hospital). Postoperative opioid consumption (total morphine-equivalent dose). Cough severity scores at multiple time points. Postoperative morbidity and mortality rates.
Statistical Analysis Plan:
Categorical data (e.g., ventilation status, ICU admission, mortality) will be analyzed using Chi-square or Fisher's exact test.
Continuous variables (e.g., pain scores, opioid consumption, hospital stay) will be compared using independent samples t-test or Mann-Whitney U test, depending on normality distribution.
Repeated measures analysis (ANOVA or Friedman test) will be applied to assess changes in pain and cough scores over time.
Significance and Impact of the Study:
This study will provide critical insights into the role of superficial cervical block in improving pain control and recovery outcomes in patients undergoing major head and neck surgery.
If effective, SCB may become a standardized part of perioperative pain management in these patients, reducing opioid dependence and enhancing early postoperative recovery.
Findings from this research will be disseminated through peer-reviewed journals and international conferences to contribute to the growing body of evidence supporting regional anesthesia techniques in head and neck surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Superficial Cervical Block (SCB) Group | Experimental | Procedure: Superficial Cervical Block (SCB) GroupPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Superficial Cervical Block (SCB) GroupPatients 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. | Procedure or surgery | Superficial Cervical Block (SCB) Group |
Primary outcome
Postoperative Pain Scores (NRS)
Time frame: 30 minutes, 4 hours, 8 hours, and 24 hours postoperatively
Pain will be assessed using the Numeric Rating Scale (NRS, 0-10) at predefined time points.
2 secondary outcomes
Postoperative Opioid Consumption
Time frame: 1 day
Cough Severity Score
Time frame: 30 minutes, 4 hours, 8 hours, and 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superficial Cervical Block (SCB) Group in people with Laryngeal Neoplasm, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Scores (NRS) (time frame: 30 minutes, 4 hours, 8 hours, and 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.