Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT05476003
Status:
UNKNOWN
Last Update Posted:
2022-08-01
First Post:
2022-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bilateral Ultrasound Guided Superficial Cervical Plexus Block After Thyroid Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'All blocks will be performed by the same anesthesiologist while the measurements will be recorded by anesthesiologist who has no idea about patient allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-08-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-28', 'studyFirstSubmitDate': '2022-07-24', 'studyFirstSubmitQcDate': '2022-07-24', 'lastUpdatePostDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of recovery', 'timeFrame': '24 hours postoperatively.', 'description': 'Improvement of the quality of recovery assessed using the 15-item quality of recovery questionnaire. The Quality of Recovery-15 included 15 items 1-Breathing 2-Food 3-Rest 4-Sleep 5-Hygiene 6-Communication 7-Support 8-Return to work 9-Feeling comfortable and in control 10-Feeling of general well-being 10-Moderate pain 12-Severe pain 13-Nausea/Vomitting 14-Worry/Anxiety 15-Feeling sad or depressed .\n\nEach item will be assessed using a10-point numerical rating scale. The total score of Quality of Recovery-15 ranges from 0 (extremely poor recovery) to 150 (all excellent recovery).'}], 'secondaryOutcomes': [{'measure': 'Postoperative analgesia', 'timeFrame': '24 hours postoperatively', 'description': 'Postoperative analgesia defined by the visual analogue scale score 30 min after arrival to recovery room then after 2, 4, 6, 12, 24 hr. If visual analogue scale˃ 3 , morphine 3 mg will be given .'}, {'measure': 'Opioid consumption', 'timeFrame': '24 hours postoperatively', 'description': 'Total post operative opioid requirement will be recorded'}, {'measure': 'Diaphragmatic Excursion', 'timeFrame': '24 hours postoperatively', 'description': 'Diaphragmatic Excursion assessed by Ultrasound'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bilateral Ultrasound Guided Superficial Cervical Plexus Block', 'Thyroid Surgery', 'Enhanced Recovery']}, 'descriptionModule': {'briefSummary': 'Evaluating ultrasound guided Bilateral Superficial Cervical Plexus Block as a part of enhanced recovery after thyroid surgery using Quality of Recovery-15 scale as a method for assessment of quality of recovery.', 'detailedDescription': 'Surgery of the thyroid gland is increasingly popular performed as ambulatory procedures in many countries. Postoperative wound pain is a common complication, especially within 24 hr after thyroid surgery, which may delay discharge or even unplanned readmissions following day surgery.\n\nSeveral strategies, including local and regional anesthesia, are now performed as core components of multimodal analgesia for postoperative pain. Adequate postoperative pain relief is imperative to improve functional outcome, accelerate early ambulation and discharge from the hospital.\n\nUltrasound-guided superficial cervical plexus block was introduced by Tran et al . The main advantages of Ultrasound-guided superficial cervical plexus block include: provide real-time visualization of anatomical structures, reduced volumes of local anesthetics, and avoid inadvertent damage or accidental puncture of vessels.\n\nOwing to its feasibility and efficacy, ultrasound-guided Bilateral superficial cervical plexus block is a technique for providing adequate regional analgesia during thyroidectomy with improvement of patient recovery.\n\nQuality of recovery after anesthesia is an important measure of the early postoperative health status of patients. Based on extensive clinical and research experience with the 40-item Quality of Recovery-40, the strongest psychometrically performing items from each of the five dimensions of the Quality of Recovery-40 were selected to create a short-form version. The Quality of Recovery-15 provides a valid, extensive, and yet efficient evaluation of postoperative Quality of Recovery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 21 to 65 years\n* American Society of Anesthesiologists physical status I or II.\n* Scheduled for elective thyroid surgery.\n\nExclusion Criteria:\n\n* Patient refusal to participate.\n* Patients with history of allergy to local anesthetics.\n* Patients with history of chronic use of pain killers .\n* Patients presented with mental dysfunction.\n* Patients with coagulation disorders.\n* Patients presented with skin or soft tissue infection at the proposed site of needle Insertion.\n* Patients with Chronic Obstructive Pulmonary Disease or Body Mass Index more than 40.'}, 'identificationModule': {'nctId': 'NCT05476003', 'briefTitle': 'Bilateral Ultrasound Guided Superficial Cervical Plexus Block After Thyroid Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Role of Bilateral Ultrasound Guided Superficial Cervical Plexus Block as a Part of Enhanced Recovery After Thyroid Surgery', 'orgStudyIdInfo': {'id': '34751/6/21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham Technique', 'description': 'Patients will receive general anesthesia plus Ultrasound-guided Bilateral superficial cervical plexus block with injection of 10 ml normal saline bilaterally.', 'interventionNames': ['Procedure: Ultrasound-guided Bilateral superficial cervical plexus block', 'Drug: Midazolam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound-guided Bilateral superficial cervical plexus block', 'description': 'Patients will receive general anesthesia plus Ultrasound-guided Bilateral superficial cervical plexus block with injection of total volume 10 ml containing Bupivacaine 0.25% (5 ml Bupivacaine 0.5 % and 5 ml normal saline).', 'interventionNames': ['Procedure: Ultrasound-guided Bilateral superficial cervical plexus block', 'Drug: Midazolam']}], 'interventions': [{'name': 'Ultrasound-guided Bilateral superficial cervical plexus block', 'type': 'PROCEDURE', 'description': 'This nerve block is typically performed in the supine or semi-sitting position, with the head turned slightly away from the side to be blocked to facilitate operator access.\n\nUnder strict aseptic condition, the linear ultrasound transducer should be placed on the lateral neck, overlying the sternocleidomastoid muscle at the level of its midpoint (approximately the level of the cricoid cartilage). Once the sternocleidomastoid muscle has been identified, the transducer is moved posteriorly until the tapering posterior edge is positioned in the middle of the screen.\n\nOnce the plexus has been identified and using In-Plane approach, the needle is passed from medial to lateral through the skin, platysma and investing layer of deep cervical fascia and the tip is placed adjacent to the plexus.\n\nFollowing negative aspiration, 1 mL of local anesthetic is injected to confirm the proper injection site. The remainder of the local anesthetic (5ml) is administered to envelop the plexus.', 'armGroupLabels': ['Sham Technique', 'Ultrasound-guided Bilateral superficial cervical plexus block']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'All patients will be premedicated with Midazolam (0.02mg/Kg).', 'armGroupLabels': ['Sham Technique', 'Ultrasound-guided Bilateral superficial cervical plexus block']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Fatma Elsamahy', 'investigatorAffiliation': 'Tanta University'}}}}