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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Dubrava

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

patienets of both sexes

18 years of age and older

ASA I or ASA II

euthyroid status

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

    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.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: total intravenous anesthesia (TIVA)No intervention 0 interventions
Group B: TIVA + bilateral intermediate cervical plexus block with 0.25% levobupivacaineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Serum Cortisol Concentration

Assessment of serum cortisol concentration as a biomarker of surgical stress response in patents undergoing total thyroidectomy with or without intermediate cervical plexus block combined with total intravenous anesthesia. Unit of measure: nmol/L

Time frame
Preoperative baseline, 1 hour postoperative, 24 hours postoperative and 48 hours postoperative
2

Salivary Cortisol Concentration

Assessment of salivary cortisol concentration as a biomarker of surgical stress response. Unit of measure: nmol/L

Time frame
Preoperative baseline, 1 hour and 24 hour postoperative
3

Serum IL-6 Concentration

Assessment of serum IL-6 concentration as a biomarker of surgical stress response in patents undergoing total thyroidectomy with or without intermediate cervical plexus block combined with total intravenous anesthesia. Unit of measure: pg/mL

Time frame
Preoperative baseline, 1 hour, 24 hours and 48 hours postoperative
4

Salivary IL-6 Concentration

Assessment of salivary IL-6 concentration as a biomarker of surgical stress response in patents undergoing total thyroidectomy with or without intermediate cervical plexus block combined with total intravenous anesthesia. Unit of measure: pg/mL

Time frame
Preoperative baseline, 1 hour and 24 hours postoperative

Secondary outcomes

1

Total Intraoperative Sufentanyl consumption

assessment of total sufentanyl consumption during surgery. Unit of measure: mcg/kg/min

Time frame
Intraoperative period
2

Total Postoperative Analgetics Consumption

Assessment of total ketoprofen and tramadol consumption during the postoperative period. Unit of measure: mg

Time frame
First 24 hours postoperative
3

Time to First Rescue Analgesia

Assessment of the time elapsed from the end of surgery until the first request for rescue analgesia. Unite of measure: minutes

Time frame
First 24 hours postoperative
4

Postoperative Pain Intensity

Assessment of postoperative pain intensity using the visual analogue pain scale where 0 indicates no pain and 10 indicates worst possible pain. Unit of measure: 0-10

Time frame
15 and 30 minutes, 1,4,12,48 hours postoperative

Other outcomes

1

The incidence of complication of the block

Time frame
From application of the block to 48 hours postoperatively

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