Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-03 @ 9:02 PM
Study NCT ID:
NCT06852651
Status:
COMPLETED
Last Update Posted:
2025-07-16
First Post:
2025-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Superficial Cervical Block Application in Postoperative Analgesia Management in Patients Undergoing Total Laryngectomy and Bilateral Neck Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007822', 'term': 'Laryngeal Neoplasms'}], 'ancestors': [{'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': '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.\n\nData Analyst Masking:\n\nThe data will be analyzed by a statistician who is blinded to the group assignments to prevent bias in statistical interpretation.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-12', 'studyFirstSubmitDate': '2025-02-24', 'studyFirstSubmitQcDate': '2025-02-25', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Pain Scores (NRS)', 'timeFrame': '30 minutes, 4 hours, 8 hours, and 24 hours postoperatively', 'description': 'Pain will be assessed using the Numeric Rating Scale (NRS, 0-10) at predefined time points.'}], 'secondaryOutcomes': [{'measure': 'Postoperative Opioid Consumption', 'timeFrame': '1 day', 'description': 'Total morphine-equivalent opioid usage will be recorded.'}, {'measure': 'Cough Severity Score', 'timeFrame': '30 minutes, 4 hours, 8 hours, and 24 hours postoperatively', 'description': 'Cough severity will be graded on a 0-4 scale (0 = no cough, 4 = severe cough affecting recovery).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Laryngeal Neoplasm']}, 'descriptionModule': {'briefSummary': '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:\n\nDoes 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.\n\nParticipants will:\n\nReceive 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', 'detailedDescription': "Background and Rationale:\n\nTotal 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.\n\nThe 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.\n\nStudy Objectives:\n\nThe 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.\n\nThe secondary objectives include:\n\nVentilation outcomes: Assessing whether the use of SCB reduces the need for postoperative ventilatory support, including prolonged mechanical ventilation or re-intubation.\n\nICU admission and hospital length of stay: Evaluating if SCB contributes to shorter ICU and hospital stays by improving pain control and facilitating early mobilization.\n\nPostoperative recovery metrics: Investigating the impact of SCB on post-extubation respiratory function, tracheostomy adaptation, and overall postoperative morbidity.\n\nOpioid consumption: Comparing opioid requirements in patients who receive SCB versus those who do not.\n\nComplication rates: Monitoring for any adverse effects related to SCB, including local anesthetic toxicity, hematoma, or block failure.\n\nStudy Design:\n\nThis 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.\n\nPatient Selection Criteria:\n\nInclusion Criteria:\n\nPatients undergoing total laryngectomy and bilateral neck dissection. Aged ≥18 years. ASA classification I-IV. Patients who provide written informed consent.\n\nExclusion Criteria:\n\nPatients undergoing emergency total laryngectomy. Patients with allergy to local anesthetics. Patients with coagulopathy or contraindications to regional anesthesia.\n\nIntervention and Methodology:\n\nAll patients will undergo standardized general anesthesia with ASA monitoring, including:\n\nElectrocardiography (ECG) Non-invasive blood pressure monitoring End-tidal CO₂ (EtCO₂) and SpO₂ monitoring Invasive arterial blood pressure monitoring (if required)\n\nAfter anesthesia induction and orotracheal intubation, patients will be divided into two groups based on anesthesiologist discretion:\n\nSCB Group: Patients will receive an ultrasound-guided superficial cervical block using 0.1 mL/kg of 0.25% bupivacaine bilaterally.\n\nControl Group: Patients will undergo standard postoperative pain management without regional anesthesia.\n\nPostoperative Pain and Recovery Assessments:\n\nPain 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.\n\nCough assessment: Cough severity will be graded on a 0-4 scale at the same time points.\n\nPostoperative ventilation status: Duration of mechanical ventilation and incidence of postoperative respiratory complications will be noted.\n\nICU and hospital stay duration: The total length of ICU and hospital stay will be compared between groups.\n\nPostoperative opioid consumption: The total amount of rescue analgesics (morphine, tramadol, etc.) will be recorded.\n\nMorbidity and mortality: Postoperative complications, including cardiovascular, pulmonary, and surgical site complications, will be documented.\n\nOutcome Measures:\n\nPrimary Outcome:\n\nPostoperative pain scores (NRS) at 30 min, 4 h, 8 h, and 24 h.\n\nSecondary Outcomes:\n\nDuration of postoperative ventilation (mechanical ventilation hours, need for reintubation).\n\nICU 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.\n\nStatistical Analysis Plan:\n\nCategorical data (e.g., ventilation status, ICU admission, mortality) will be analyzed using Chi-square or Fisher's exact test.\n\nContinuous 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.\n\nRepeated measures analysis (ANOVA or Friedman test) will be applied to assess changes in pain and cough scores over time.\n\nSignificance and Impact of the Study:\n\nThis 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.\n\nIf effective, SCB may become a standardized part of perioperative pain management in these patients, reducing opioid dependence and enhancing early postoperative recovery.\n\nFindings 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for total laryngectomy with bilateral neck dissection.\n* Age ≥18 years.\n* ASA (American Society of Anesthesiologists) classification I-IV.\n* Patients who provide written informed consent.\n\nExclusion Criteria:\n\n* Patients undergoing emergency surgery.\n* Patients with known allergies to local anesthetics (e.g., bupivacaine, lidocaine).\n* Patients with coagulopathy or bleeding disorders that contraindicate regional anesthesia.\n* Patients with severe cognitive impairment affecting informed consent.\n* Patients with infection at the injection site preventing SCB administration.'}, 'identificationModule': {'nctId': 'NCT06852651', 'briefTitle': 'The Efficacy of Superficial Cervical Block Application in Postoperative Analgesia Management in Patients Undergoing Total Laryngectomy and Bilateral Neck Dissection', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Başakşehir Çam & Sakura City Hospital'}, 'officialTitle': 'The Efficacy of Superficial Cervical Block Application in Postoperative Analgesia Management in Patients Undergoing Total Laryngectomy and Bilateral Neck Dissection', 'orgStudyIdInfo': {'id': 'Superficial Cervical Block'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Superficial Cervical Block (SCB) Group', 'description': 'Patients undergoing total laryngectomy and bilateral neck dissection who receive a superficial cervical block (SCB) for postoperative pain management.\n\nThe block will be performed bilaterally under ultrasound guidance using 0.1 mL/kg of 0.25% bupivacaine after anesthesia induction.\n\nPostoperative pain scores, opioid consumption, ventilation status, ICU and hospital length of stay, and complications will be recorded.', 'interventionNames': ['Procedure: Superficial Cervical Block (SCB) Group']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group (No Block)', 'description': 'Patients undergoing total laryngectomy and bilateral neck dissection who receive standard postoperative analgesia without a superficial cervical block (SCB).\n\nPostoperative pain management will consist of intravenous analgesics as per institutional protocols.\n\nThe same postoperative parameters (pain scores, opioid use, ventilation status, ICU/hospital stay, and complications) will be assessed for comparison.'}], 'interventions': [{'name': 'Superficial Cervical Block (SCB) Group', 'type': 'PROCEDURE', 'description': 'Patients in this group will receive a bilateral superficial cervical block under ultrasound guidance after anesthesia induction but before the surgical procedure begins.\n\nThe block will be performed using 0.1 mL/kg of 0.25% bupivacaine per side, targeting the superficial branches of the cervical plexus.\n\nThe primary goal is to assess its efficacy in postoperative pain management and its impact on recovery parameters.', 'armGroupLabels': ['Superficial Cervical Block (SCB) Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Basaksehir cam and sakura city hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Başakşehir Çam & Sakura City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Hilal AKCA', 'investigatorAffiliation': 'Başakşehir Çam & Sakura City Hospital'}}}}