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Bilateral Ultrasound Guided Superficial Cervical Plexus Block After Thyroid Surgery

Primary Purpose

Bilateral Ultrasound Guided Superficial Cervical Plexus Block, Thyroid Surgery, Enhanced Recovery

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound-guided Bilateral superficial cervical plexus block
Midazolam
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bilateral Ultrasound Guided Superficial Cervical Plexus Block

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 21 to 65 years
  • American Society of Anesthesiologists physical status I or II.
  • Scheduled for elective thyroid surgery.

Exclusion Criteria:

  • Patient refusal to participate.
  • Patients with history of allergy to local anesthetics.
  • Patients with history of chronic use of pain killers .
  • Patients presented with mental dysfunction.
  • Patients with coagulation disorders.
  • Patients presented with skin or soft tissue infection at the proposed site of needle Insertion.
  • Patients with Chronic Obstructive Pulmonary Disease or Body Mass Index more than 40.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Active Comparator

    Arm Label

    Sham Technique

    Ultrasound-guided Bilateral superficial cervical plexus block

    Arm Description

    Patients will receive general anesthesia plus Ultrasound-guided Bilateral superficial cervical plexus block with injection of 10 ml normal saline bilaterally.

    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).

    Outcomes

    Primary Outcome Measures

    Quality of recovery
    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 . Each 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).

    Secondary Outcome Measures

    Postoperative analgesia
    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 .
    Opioid consumption
    Total post operative opioid requirement will be recorded
    Diaphragmatic Excursion
    Diaphragmatic Excursion assessed by Ultrasound

    Full Information

    First Posted
    July 24, 2022
    Last Updated
    July 28, 2022
    Sponsor
    Tanta University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05476003
    Brief Title
    Bilateral Ultrasound Guided Superficial Cervical Plexus Block After Thyroid Surgery
    Official Title
    Role of Bilateral Ultrasound Guided Superficial Cervical Plexus Block as a Part of Enhanced Recovery After Thyroid Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 15, 2022 (Anticipated)
    Primary Completion Date
    August 15, 2023 (Anticipated)
    Study Completion Date
    September 15, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tanta University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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. Several 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. Ultrasound-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. Owing 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. Quality 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bilateral Ultrasound Guided Superficial Cervical Plexus Block, Thyroid Surgery, Enhanced Recovery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    All blocks will be performed by the same anesthesiologist while the measurements will be recorded by anesthesiologist who has no idea about patient allocation.
    Allocation
    Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sham Technique
    Arm Type
    Sham Comparator
    Arm Description
    Patients will receive general anesthesia plus Ultrasound-guided Bilateral superficial cervical plexus block with injection of 10 ml normal saline bilaterally.
    Arm Title
    Ultrasound-guided Bilateral superficial cervical plexus block
    Arm Type
    Active Comparator
    Arm 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).
    Intervention Type
    Procedure
    Intervention Name(s)
    Ultrasound-guided Bilateral superficial cervical plexus block
    Intervention 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. Under 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. Once 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. Following 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Midazolam
    Intervention Description
    All patients will be premedicated with Midazolam (0.02mg/Kg).
    Primary Outcome Measure Information:
    Title
    Quality of recovery
    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 . Each 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).
    Time Frame
    24 hours postoperatively.
    Secondary Outcome Measure Information:
    Title
    Postoperative analgesia
    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 .
    Time Frame
    24 hours postoperatively
    Title
    Opioid consumption
    Description
    Total post operative opioid requirement will be recorded
    Time Frame
    24 hours postoperatively
    Title
    Diaphragmatic Excursion
    Description
    Diaphragmatic Excursion assessed by Ultrasound
    Time Frame
    24 hours postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients aged 21 to 65 years American Society of Anesthesiologists physical status I or II. Scheduled for elective thyroid surgery. Exclusion Criteria: Patient refusal to participate. Patients with history of allergy to local anesthetics. Patients with history of chronic use of pain killers . Patients presented with mental dysfunction. Patients with coagulation disorders. Patients presented with skin or soft tissue infection at the proposed site of needle Insertion. Patients with Chronic Obstructive Pulmonary Disease or Body Mass Index more than 40.

    12. IPD Sharing Statement

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    Bilateral Ultrasound Guided Superficial Cervical Plexus Block After Thyroid Surgery

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