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Efficacy of Adding Dexmedetomidine in Ultrasound-guided Intermediate Cervical Plexus Block for Thyroidectomy Surgery

Primary Purpose

Pain, Postoperative, Cancer of Larynx

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
dexmedetomidine
bupivacaine 0.25%
Thyroidectomy Surgery
Ultrasound-guided intermediate Cervical Plexus Block Technique
Sponsored by
National Cancer Institute, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Intermediate Cervical Plexus Block, dexmedetomidine, bupivacaine, Thyroidectomy surgery

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Physical status American society Anesthesiologists ASA II and III. Age ≥ 18 and ≤ 60 Years. Patient undergoing thyroidectomy for cancer surgery. Exclusion Criteria: Patient refusal. Known sensitivity or contraindication to local anesthetics or dexmedetomidine. History of psychological disorders. Retro-sternal goiter and altered anatomical landmarks. Localized infection at the site of block. Coagulopathy with international normalized ratio (INR) ≥ 1.6: hereditary (e.g., hemophilia, fibrinogen abnormalities & deficiency of factor II) - acquired (e.g., impaired liver functions with prothrombin concentration less than 60 %, vitamin K deficiency & therapeutic anticoagulants drugs).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Active Comparator

    Arm Label

    Group (A)

    Group (B)

    Arm Description

    bupivacaine 0.25% only

    bupivacaine 0.25% and dexmedetomidine

    Outcomes

    Primary Outcome Measures

    first rescue analgesia
    First time (minutes) opioids requested postoperative when pain score is >3 .

    Secondary Outcome Measures

    Total intraoperative fentanyl consumption.
    the doses of fentanyl will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.
    postoperative opioids consumption.
    Total patient's morphine requirements within 24 hours postoperative.
    Post-operative pain scores.
    Post-operative pain scores using Visual analogue score (VAS) (0 mm = no pain to 10mm = worst pain imaginable) at predetermined time intervals
    Any complications will be recorded.
    Any complications such as failed block, hypotension, unintentional intravascular injection of LA and local anesthetic toxicity will be recorded.

    Full Information

    First Posted
    February 21, 2023
    Last Updated
    April 27, 2023
    Sponsor
    National Cancer Institute, Egypt
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05814744
    Brief Title
    Efficacy of Adding Dexmedetomidine in Ultrasound-guided Intermediate Cervical Plexus Block for Thyroidectomy Surgery
    Official Title
    Efficacy of Adding Dexmedetomidine as Adjuvant With Bupivacaine in Ultrasound-guided Intermediate Cervical Plexus Block for Thyroidectomy Surgery: Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2023 (Anticipated)
    Primary Completion Date
    October 2023 (Anticipated)
    Study Completion Date
    November 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Cancer Institute, Egypt

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The cervical plexus block (CPB) is one such block used to provide effective anesthesia and analgesia for surgery in the head and neck region. The cervical fascia was first described as a very strong and resisting structure, consisting of two layers, superficial and deep. But more recently classified the cervical fascia as superficial/subcutaneous and deep. The deep cervical fascia is further divided into three layers: (a) the superficial layer, which was also called the investing fascia but is now referred to as the masticator fascia, submandibular fascia or sternocleidomastoid (SCM)-trapezius fascia, (b) the middle layer, which is suggested as to be named as strap muscle fascia or visceral fascia; and (c) the deep layer or the 'prevertebral fascia'. Intermediate cervical plexus block (CPB) has been found to be very effective in procedures of neck such as thyroid surgeries and carotid endarterectomy. The duration of analgesia following the nerve blocks is a matter of concern as most of the blocks last for only a few hours. Interestingly, resurgence of the use of α2-agonists in combination with local anesthetics has dramatically improved the duration of action of these blocks. Dexmedetomidine is a potent α2 agonist and is now emerging as an adjuvant to regional anesthesia and analgesia. Little evidence is available supporting the usefulness of dexmedetomidine in bilateral intermediate CPB. Therefore, the current study will be conducted to compare the duration and effectiveness of post-thyroidectomy analgesia of bilateral intermediate CPB using 20 ml bupivacaine 0.25% (Group A) or 20 ml of bupivacaine 0.25% with 1 μg/kg dexmedetomidine (Group B).
    Detailed Description
    - Objectives: The aim of this study is to evaluate the effect of adding dexmedetomidine as adjuvant to bupivacaine in ultrasound guided Intermediate Cervical Plexus Block (CPB) for thyroidectomy surgery. - Study Design : Double-blind randomized controlled study where both patient and investigator don't know the drug. - Study Methodology: Population of study & disease Condition Adult patients at National Cancer Institute scheduled for thyroidectomy fulfilling the eligibility criteria. Interventions: All patients will be medically checked in the preoperative assessment clinic {history, physical examination, investigations (e.g., complete blood picture, coagulation profile, liver & kidney functions, ECG for patients above 40 years, pulmonary function test (PFT) and any other necessary investigations if required for high-risk patients.)} Preoperative assessment at night of surgery. The patients will be instructed how to report pain by means of visual analogue scale [VAS] during the preoperative assessment. Informed consent will be obtained. In the holding room, the patients will be continuously monitored for pulse, blood pressure, oxygen saturation. Intravenous (IV) 18-gauge cannula will be inserted for all patients. Midazolam 0.02 mg/Kg will be administered. For each patient, 7-10 ml/kg of intravenous (IV) ringer acetate will be administered if required to replace fluid deficiency 30 min before the surgery. Portable ultrasound machine, resuscitation equipment &drugs (e.g., epinephrine, lipid emulsion), sterile gloves and surgical towels should be available. Anesthetic Management: Monitoring: all patients will be monitored continuously using ECG, Non Invasive Blood Pressure (NIBP), peripheral arterial oxygen saturation and end tidal carbon dioxide throughout the duration of surgery. Regimen of IV 2 μg/kg fentanyl and propofol IV 2 mg /kg will be used for Induction of general anesthesia. Tracheal intubation will be facilitated using 0.5 mg/kg IV of rocuronium. After Induction of general anesthesia (GA) both groups' patients will receive bilateral Intermediate Cervical plexus block, either with 20 ml bupivacaine 0.25% (Group A) or 20 ml of bupivacaine 0.25% with 1 μg/kg dexmedetomidine (Group B). Anesthesia will be maintained with inhaled sevoflurane with minimum alveolar concentration (MAC) 2-2.5% in oxygen enriched air (FiO2=50%) and top up doses of rocuronium (0.1 mg/kg) IV will be administered as required. All patients will receive 1 g of IV paracetamol. Additional bolus doses of fentanyl 0.5 µg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels. At the end of surgery, the residual neuromuscular blockade will be reversed using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), and extubation will be performed after complete recovery of the airway reflexes. After surgery the patients will be transferred to the post anesthesia care unit where pain scores and mean arterial pressure (MAP) and heart rate will be noted immediately on arrival and at 2, 4, 6, 12 and 24 hours postoperatively. The patients will be observed in the postoperative care unit for 2 h, and rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the pain score >3. The total amount of morphine given in 24 hours will be recorded in the two groups. Thereafter, the patients will be shifted to ward and will be given acetaminophen 1 g IV every 8 hours. Ultrasound-guided intermediate cervical plexus block (CPB) Technique: The block is performed with full aseptic precautions. The block is performed in the supine position, the head is turned to the opposite side and. The patient's neck and upper chest should be exposed so that the relative length and position of the SCM can be assessed. The skin is disinfected and the transducer is placed on the lateral neck, overlying the SCM at the level of its midpoint (approximately the level of the cricoid cartilage). Once the SCM has been identified, the transducer is moved posteriorly until the tapering posterior edge is positioned in the middle of the screen. At this point, an attempt should be made to identify the brachial plexus and/or the interscalene groove between the anterior and middle scalene muscles. The cervical plexus is visible as a small collection of hypoechoic nodules (honeycomb appearance) immediately superficial to the prevertebral fascia that overlies the interscalene groove. Once the plexus has been identified, local anesthetic (LA) can be injected using long axis, in plane approach by keeping the probe in transverse position. For intermediate cervical plexus nerve block, the injection is made between the investing layer of the deep cervical fascia and the prevertebral fascia. Following negative aspiration, 1-2 mL of local anesthetic is injected to confirm the proper injection site. The remainder of the local anesthetic is administered to envelop the plexus. Possible Risk and Adverse events: Failure of block. Local anesthetic toxicity. f) Sample size (number of participants included approved by statistical calculation A recent randomized double blinded study showed that US-guided intermediate cervical plexus block (CPB) was better than superficial CBP for post-operative analgesia in patients undergoing total thyroidectomy. On the other-hand a randomized double blinded study found that adding dexmedetomidine to superficial CPB improve analgesia for thyroid surgeries. Based on the results (evidences) of previous study on the evidence that intermediate CPB is better than superficial CBP for post-operative analgesia the investigators based the calculation of sample size for the current study. In this study, they found that for the patients' group where CPB is done with 20 ml 0.5% ropivacaine (Group A) or 20 ml 0.5% ropivacaine with 0.5 µg/kg dexmedetomidine (Group B) the following was found: Longer duration of analgesia in group B than group A (1696.2±100.2 minutes and 976.8±81.6 minutes respectively, p <0.001). Median VAS score at 12 hours postoperatively was 2(1-2) in group A vs 0(0-1) in group B, and median VAS score at 24 hours postoperatively was 5(5-6) in group A vs 2(2-2) in group B, p < 0.001. Based on the above estimates for duration of analgesia and VAS scores in both groups, sample size was calculated with these expected means (or medians as an approximate estimate) and a pooled standard deviation SD (being always conservative and taking the largest SD), assuming a power of 95% and level of significance of 0.01, maximum sample size needed per group was 5 with a total of 10 patients to find the above differences between the two groups with the power and significance described. As the investigators want to assume normality of variables as VAS score, sample size was corrected to be 30 per group with a total of 60 patients to be equally and randomly allocated to either group receiving bupivacaine alone or with dexmedetomidine. Randomization was done using SPSS , table of random allocation of the two study groups. d) Statistical analysis of data: Data will be collected from patients and tabulated using SPSS version 23.0 (SPSS inc., Chicago, USA). Quantitative data will be presented as mean and standard deviation if found normally distributed and median and range if else. Parametric and non-parametric t-test will compare means of two independent groups such as age, weight, duration of analgesia, vitals of the patients, VAS score …etc. Rates of complications will be compared using Chi-square or Fisher exact tests. P value will be considered significant if ≤0.05 and will be always two tailed. e) Source of funding: Funded by National Cancer Institute, Cairo University.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative, Cancer of Larynx
    Keywords
    Intermediate Cervical Plexus Block, dexmedetomidine, bupivacaine, Thyroidectomy surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomized
    Masking
    ParticipantInvestigator
    Masking Description
    double blind
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group (A)
    Arm Type
    Sham Comparator
    Arm Description
    bupivacaine 0.25% only
    Arm Title
    Group (B)
    Arm Type
    Active Comparator
    Arm Description
    bupivacaine 0.25% and dexmedetomidine
    Intervention Type
    Drug
    Intervention Name(s)
    dexmedetomidine
    Other Intervention Name(s)
    precedex vial
    Intervention Description
    adding dexmedetomidine as adjuvant with bupivacaine in Ultrasound-guided Intermediate Cervical Plexus Block for Thyroidectomy surgery.
    Intervention Type
    Drug
    Intervention Name(s)
    bupivacaine 0.25%
    Other Intervention Name(s)
    Sensorcaine®
    Intervention Description
    patients will receive bilateral Intermediate Cervical plexus block with 20 ml bupivacaine 0.25%.
    Intervention Type
    Procedure
    Intervention Name(s)
    Thyroidectomy Surgery
    Intervention Description
    surgical removal of all or part of thyroid gland.
    Intervention Type
    Procedure
    Intervention Name(s)
    Ultrasound-guided intermediate Cervical Plexus Block Technique
    Intervention Description
    the injection of local anesthetic in intermediate cervical plexus nerve block is made between the investing layer of the deep cervical fascia and the prevertebral fascia. Following negative aspiration, 1-2 mL of local anesthetic is injected to confirm the proper injection site.
    Primary Outcome Measure Information:
    Title
    first rescue analgesia
    Description
    First time (minutes) opioids requested postoperative when pain score is >3 .
    Time Frame
    the first 24 hours of postoperative period
    Secondary Outcome Measure Information:
    Title
    Total intraoperative fentanyl consumption.
    Description
    the doses of fentanyl will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.
    Time Frame
    throughout the duration of the surgery
    Title
    postoperative opioids consumption.
    Description
    Total patient's morphine requirements within 24 hours postoperative.
    Time Frame
    24 hours postoperative
    Title
    Post-operative pain scores.
    Description
    Post-operative pain scores using Visual analogue score (VAS) (0 mm = no pain to 10mm = worst pain imaginable) at predetermined time intervals
    Time Frame
    immediately postoperative (0 hours ), 2, 4, 6, 12 and 24 hours postoperative
    Title
    Any complications will be recorded.
    Description
    Any complications such as failed block, hypotension, unintentional intravascular injection of LA and local anesthetic toxicity will be recorded.
    Time Frame
    throughout the duration of the surgery and 24 hours postoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Physical status American society Anesthesiologists ASA II and III. Age ≥ 18 and ≤ 60 Years. Patient undergoing thyroidectomy for cancer surgery. Exclusion Criteria: Patient refusal. Known sensitivity or contraindication to local anesthetics or dexmedetomidine. History of psychological disorders. Retro-sternal goiter and altered anatomical landmarks. Localized infection at the site of block. Coagulopathy with international normalized ratio (INR) ≥ 1.6: hereditary (e.g., hemophilia, fibrinogen abnormalities & deficiency of factor II) - acquired (e.g., impaired liver functions with prothrombin concentration less than 60 %, vitamin K deficiency & therapeutic anticoagulants drugs).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aya M. Ahmed, MD
    Phone
    +20201092082844
    Email
    Aya.m.elbaz@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mamdouh M. Elshal, Doctor
    Phone
    01222805447
    Email
    mamdouh.mahmoud@nci.cu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gehan M. Kamal, Prof.
    Organizational Affiliation
    National Cancer Institute, Anesthesia, Pain Relief and ICU Department
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Mohamed E. Hassan, Ass. Prof.
    Organizational Affiliation
    National Cancer Institute, Anesthesia, Pain Relief and ICU Department
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Mai M. Elrawas, Doctor
    Organizational Affiliation
    National Cancer Institute, Anesthesia, Pain Relief and ICU Department
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32001907
    Citation
    Syal K, Chandel A, Goyal A, Sharma A. Comparison of ultrasound-guided intermediate vs subcutaneous cervical plexus block for postoperative analgesia in patients undergoing total thyroidectomy: A randomised double-blind trial. Indian J Anaesth. 2020 Jan;64(1):37-42. doi: 10.4103/ija.IJA_483_19. Epub 2020 Jan 7.
    Results Reference
    background
    PubMed Identifier
    25946970
    Citation
    Natale G, Condino S, Stecco A, Soldani P, Belmonte MM, Gesi M. Is the cervical fascia an anatomical proteus? Surg Radiol Anat. 2015 Nov;37(9):1119-27. doi: 10.1007/s00276-015-1480-1. Epub 2015 May 7.
    Results Reference
    background
    PubMed Identifier
    23913739
    Citation
    Guidera AK, Dawes PJ, Fong A, Stringer MD. Head and neck fascia and compartments: no space for spaces. Head Neck. 2014 Jul;36(7):1058-68. doi: 10.1002/hed.23442. Epub 2014 Jan 29.
    Results Reference
    background
    Citation
    Kim, J.-S. and H.Y. Kim, Cervical plexus block. Surgical Anatomy of the Cervical Plexus and its Branches, 2022: p. 189-202.
    Results Reference
    background
    PubMed Identifier
    24227357
    Citation
    Egan RJ, Hopkins JC, Beamish AJ, Shah R, Edwards AG, Morgan JD. Randomized clinical trial of intraoperative superficial cervical plexus block versus incisional local anaesthesia in thyroid and parathyroid surgery. Br J Surg. 2013 Dec;100(13):1732-8. doi: 10.1002/bjs.9292.
    Results Reference
    background
    PubMed Identifier
    24648597
    Citation
    Kaygusuz K, Kol IO, Duger C, Gursoy S, Ozturk H, Kayacan U, Aydin R, Mimaroglu C. Effects of adding dexmedetomidine to levobupivacaine in axillary brachial plexus block. Curr Ther Res Clin Exp. 2012 Jun;73(3):103-11. doi: 10.1016/j.curtheres.2012.03.001.
    Results Reference
    background
    PubMed Identifier
    27792047
    Citation
    Andersen JH, Grevstad U, Siegel H, Dahl JB, Mathiesen O, Jaeger P. Does Dexmedetomidine Have a Perineural Mechanism of Action When Used as an Adjuvant to Ropivacaine?: A Paired, Blinded, Randomized Trial in Healthy Volunteers. Anesthesiology. 2017 Jan;126(1):66-73. doi: 10.1097/ALN.0000000000001429.
    Results Reference
    background
    Available IPD and Supporting Information:
    Available IPD/Information Type
    Individual Participant Data Set
    Available IPD/Information URL
    https://drive.google.com/file/d/12gNVWYJj8dyy6Bh-6G59rFn2AQzjHycS/view?usp=share_link
    Available IPD/Information Type
    Informed Consent Form
    Available IPD/Information URL
    https://drive.google.com/file/d/1qPpYheG63CcWJqwWAD3ma3jFmmqCPWgm/view?usp=share_link
    Available IPD/Information Type
    Study Protocol
    Available IPD/Information URL
    https://drive.google.com/file/d/16x_dHL6GsO6V-K3p13T9EluZi20l4WtN/view?usp=share_link

    Learn more about this trial

    Efficacy of Adding Dexmedetomidine in Ultrasound-guided Intermediate Cervical Plexus Block for Thyroidectomy Surgery

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