RecruitingPhase 4NCT07600580

The Association Between Bilateral Intermediate Cervical Plexus Block During Total Thyroidectomy and Surgical Stress Response

The Association Between Bilateral Intermediate Cervical Plexus Block and Salivary and Serum Biomarkers of Surgical Stress Response During Total Thyroidectomy


Sponsor

University Hospital Dubrava

Enrollment

48 participants

Start Date

May 13, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this study is to determine the impact of ultrasound-guided bilateral intermediate cervical plexus block on the surgical stress response in patients undergoing total thyroidectomy, as measured by the concentration of stress and inflammatory biomarkers in the participants' saliva and serum. The study will be conducted on 48 subjects divided into two groups of 24: a control group receiving total intravenous anesthesia (TIVA) and an experimental group receiving TIVA combined with a bilateral intermediate cervical plexus block. Investigators hypothesized that a combination of bilateral intermediate cervical plexus block and total intravenous anesthesia (TIVA) would reduce the surgical stress response, as measured by salivary and blood biomarkers, compared to TIVA alone in patients undergoing total thyroidectomy. Should the research confirm the hypothesis, it will provide an objective scientific argument for including the block in standard anesthetic protocols for total thyroidectomy surgeries, with the ultimate goal of reducing the surgical stress response and ensuring faster patient recovery.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • patienets of both sexes
  • years of age and older
  • ASA I or ASA II
  • euthyroid status
  • signed informed consent

Exclusion Criteria14

  • patients who refuse to sign the informed consent form
  • infection at the block injection site
  • hypersensitivity or contraindications to the medications used in the study
  • hypothyroidism or hyperthyroidism at the time of surgery
  • presence of substernal goiter
  • additional surgical interventions during the procedure
  • history of previous neck surgery or radiation
  • coagulopathy
  • uncontrolled respiratory disease
  • diabetes mellitus
  • autoimmune disease
  • chronic corticosteroid therapy
  • smokers
  • pregnant women.

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Interventions

OTHERbilateral ultrasound guided intermediate cervical plexus block with 0,25% levobupivacaine

Following the induction of general anesthesia in the study group, a bilateral intermediate cervical plexus block will be performed. The subject's head is carefully turned away from the side of the neck where the block is being administered. A linear ultrasound probe is placed transversely at the midpoint of an imaginary line connecting the mastoid process and the sternal attachment of the sternocleidomastoid muscle (SCM). The cervical plexus is visualized as a small cluster of hypoechoic nodules beneath the posterolateral border of the SCM and immediately above the prevertebral fascia. After sterile preparation, a 22-gauge needle is inserted under ultrasound guidance in a lateromedial direction. The needle tip is positioned within the specified space, approximately 2 cm medial to the skin entry point. Following a negative aspiration test, 10 mL of 0.25% levobupivacaine is injected and visualized on the ultrasound screen. The same procedure is then repeated on the contralateral side.


Locations(1)

University Hospital Dubrava

Zagreb, City of Zagreb, Croatia

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NCT07600580


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