The Association Between Bilateral Intermediate Cervical Plexus Block and Salivary Biomarkers of Surgical Stress Response Following Total Thyroidectomy
The aim of this study is to evaluate how an ultrasound-guided bilateral intermediate cervical plexus block affects the surgical stress response in individuals undergoing total thyroidectomy. The primary objective is to quantify this physiological response through the analysis of specific stress and inflammatory biomarkers collected from the participants' saliva.
The clinical trial will encompass a total of 48 patients, randomized equally into two distinct cohorts of 24 participants each. The control group will undergo standard total intravenous anesthesia (TIVA), whereas the experimental group will receive the bilateral intermediate cervical plexus block in combination with the TIVA protocol.
It is hypothesized that integrating this regional nerve block with total intravenous anesthesia will significantly attenuate the surgical stress response, evidenced by a reduction in salivary biomarker concentration, compared to utilizing TIVA alone during thyroid surgery.
Validating this hypothesis would offer robust scientific evidence to advocate for the routine integration of the bilateral intermediate cervical plexus block into standard anesthetic practices for total thyroidectomy. Ultimately, this approach aims to minimize perioperative stress and facilitate a more rapid postoperative recovery for patients.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: Antonija Mihelčić
- 전화번호: +385996830715
- 이메일: antonijamihelcic@yahoo.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- ASA I or ASA II
- euthyroid status
- signed informed consent
Exclusion Criteria:
- patients who refuse to sign the informed consent form
- infection at the block injection site
- hypersensitivity or contraindications to the medication used in the study
- hypo/hyperthyroidism at the time of surgery
- presence of substernal goiter
- additional surgical interventions during the procedure
- history of previous neck surgery or radiation
- coagulopathy
- uncontroled respiratory disease
- diabetes mellitus
- autoimune disease
- chronic corticosteroid therapy
- smokers
- pregnant women
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: TIVA alone
|
|
|
실험적: TIVA + bilateral intermediate cervical plexus block with 0,25% levobupivacaine
|
Following the induction of general anesthesia in the study group, an ultrasound-guided bilateral intermediate cervical plexus block will be performed. The cervical plexus is visualized on the screen as a small cluster of hypoechoic nodules beneath the posterolateral border of the sternocleidomastoid muscle 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 will be repeated on the contralateral side. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Salivary IL-6 Concentration
기간: Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery
|
Unit of measure: pg/mL
|
Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery
|
|
Salivary Cortisol Concentration
기간: Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery
|
Unit of measure: nmol/L
|
Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery
|
|
Salivary Alpha-amylase Activity
기간: Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery
|
Unit of measure: U/L
|
Baseline (preoperatively), 1 hour after the completion of surgery, and 24 hours after the completion of surgery
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Total Intraoperative Sufentanyl Consumption
기간: Intraoperative period
|
Unit of measure: mcg/kg/min
|
Intraoperative period
|
|
Total Postoperative Analgetics consumption
기간: During the first 24 hours after the completion of surgery
|
Unit of measure: mg
|
During the first 24 hours after the completion of surgery
|
|
Time to Rescue Analgesia
기간: During the first 24 hours after the completion of surgery
|
Unit of measure: minutes
|
During the first 24 hours after the completion of surgery
|
|
Hemodynamic Stability (heart rate)
기간: Intraoperative period and during the first 24 hours after the completion of surgery
|
Heart rate will be recorded during the resaerch period.
Unit of measure: beats/minute
|
Intraoperative period and during the first 24 hours after the completion of surgery
|
|
Postoperative Sedation Level
기간: During the first 4 hours after the completion of surgery
|
Postoperative seadtion level will be mesured by Richmond Agitation-Sedation Scale ranging from -5 (deepely sedated) to +4 (highly agitated), with 0 being completely alert and calm.
|
During the first 4 hours after the completion of surgery
|
|
Postoperative Nausea and Vomiting
기간: During the first 24 hours after the completion of surgery
|
The incidence of postoperative nausea and vomiting will be determined
|
During the first 24 hours after the completion of surgery
|
|
Hemodynamic Stability (blood pressure)
기간: Intraoperative period and during the first 24 hours after the completion of surgery
|
Systolic, diastolic and mean arterial pressure will be recorded during the research peroid. Unit of measure: mmHg |
Intraoperative period and during the first 24 hours after the completion of surgery
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of block complication
기간: From the administration of the block up to 48 hours after the completion of surgery
|
The incidence of possible complication of the block will be determined.
|
From the administration of the block up to 48 hours after the completion of surgery
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 0119-04-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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