Clinical trial NCT04414488: The Impact of Regional Anaesthesia on Hormone Levels in Thoracic Surgery.
Official title: The Impact of Regional Anaesthesia on Hormone Levels in Thoracic Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hormones
Anesthesia, Conduction
Thoracic Surgical Procedure
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population consisted of consecutive patients scheduled for elective videothoracoscopic procedures.

Brief summary: Basic aspects of thoracic anaesthesia are general anesthesia often combined with regional anesthesia, intubation with double lumen tube and separation of lung ventilation. Proper assessment of pain and adequate analgesia in intraoperative and postoperative period is a challenging issue for medical practitioners. Intraoperative trauma may lead to many metabolic implications and disturbance of haemostasis, what can be reflected in change of blood and saliva hormone and other substance levels. The aim of this study is to assess the impact of regional anesthesia on hormone levels in patients requiring videothoracoscopic procedures.

Detailed description: Basic aspects of thoracic anaesthesia are general anesthesia often combined with regional anesthesia, intubation with double lumen tube and separation of lung ventilation. Proper assessment of pain and adequate analgesia in intraoperative and postoperative period is a challenging issue for medical practitioners. Intraoperative trauma may lead to many metabolic implications and disturbance of haemostasis, what can be reflected in change of blood and saliva hormone and other substance levels, such as alpha-amylase, cortisol, testosterone, secretory IgA, β-endorphin, nerve growth factor, calcitonin gene-related protein and P substance. The aim of this study is to assess the impact of regional anesthesia on hormone levels in postoperative period. Saliva was collected from participants in order to perform laboratory tests, using a special disposable Salivette tube (Sarstedt AG \& Co, Germany). Saliva was collected by placing a sterile tampon under the tongue or chewing for 30-45 seconds. The soaked saliva pad was then placed in a suspended insert with a perforated bottom. The insert with a tampon was placed in a centrifuge tube and closed with a stopper. Next the tube was centrifuged (1000 x g for 10 min.) to obtain a ready to test saliva supernatant. Approximately 0,7 ml of the supernatant from every sample collected was used for further testing. Samples were frozen after centrifugation at - 85°C until performing laboratory tests. Blood was collected for laboratory tests from the ulnar vein. Blood for testing was collected using disposable equipment in a volume of 5ml into a tube containing ethylenediaminetetraacetic acid (EDTA) and aprotinin. Next the tube was centrifuged (1000 x g for 5 min.). After centrifugation and separation of morphotic elements, the obtained plasma was divided into two tubes and frozen at - 85°C until performing laboratory tests.

Eligibility criteria: Inclusion Criteria:

-qualification to elective videothoracoscopic procedures and general anaesthesia

Exclusion Criteria:

* lack of consent to participation in the study,
* significant coagulopathy,
* contraindication to the thoracic paravertebral block or drugs used in protocol,
* history of chronic pain,
* chest wall neoplastic invasion,
* previous thoracic spine surgery,
* mental state preventing from effective use of PCA device,
* renal failure (GFR \<60 ml/min/1,73 m2).

Primary outcomes:
measure: Alpha-amylase activity. [U/ml]
timeFrame: 24 hours
measure: Cortisol concentration. [ng/ml]
timeFrame: 24 hours
measure: Testosterone concentration. [pg/ml]
timeFrame: 24 hours
measure: Secretory Immunoglobulin A concentration. (sIgA)
timeFrame: 24 hours
measure: β-endorphin concentration.
timeFrame: 24 hours
measure: P substance concentration. [pg/ml]
timeFrame: 24 hours
measure: Nerve Growth Factor concentration. [ng/ml]
timeFrame: 24 hours
measure: Calcitonin Gene-related Peptide concentration. [pg/ml]
timeFrame: 24 hours
Secondary outcomes:
measure: Pain intensity (NRS)
timeFrame: 24 hours
measure: Arterial blood pressure [mmHg]
timeFrame: 24 hours
measure: Heart rate [bmp]
timeFrame: 24 hours
measure: Arterial blood saturation measured by pulse oximetry [%]
timeFrame: 24 hours
Other outcomes:
Locations:
city: Zabrze
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1
state: Silesia
Study officials:
References: