Clinical Trials Directory

Trials / Completed

CompletedNCT04414488

The Impact of Regional Anaesthesia on Hormone Levels in Thoracic Surgery.

Status
Completed
Phase
Study type
Observational
Enrollment
119 (actual)
Sponsor
Medical University of Silesia · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREThoracic paravertebral block (ThPVB)Before the induction of general anaesthesia a single-shot ThPVB was performed at the Th3 to Th4 level, approximately, 2.5 to 3 cm lateral to tip of a spinous process. A preblock ultrasound examination was undertaken to assess the depth of the transverse process and the pleura. An insulated 10 cm long needle was used and this was connected to a peripheral nerve stimulator with a set current of 2.5 milliampere(mA). The current was gradually reduced as the needle was inserted until the appearance of visible intercostal muscles activity with a current of 0.3 to 0.5mA (paravertebral space identification). Plain bupivacaine (0.3 ml\*kg-1) was then injected after a negative aspiration test for air or blood. The efficacy of the blockade to cold was checked after 20 min with a plastic ampoule of saline kept in the freezer. Testing was symmetrical on both sides of thorax. A difference in sensation to cold between the blocked and unblocked sides was taken to indicate an effective block.

Timeline

Start date
2018-05-01
Primary completion
2019-12-01
Completion
2019-12-01
First posted
2020-06-04
Last updated
2020-06-04

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT04414488. Inclusion in this directory is not an endorsement.