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

M

Medical University of Silesia

Status

Completed

Conditions

Thoracic Surgical Procedure
Anesthesia, Conduction
Hormones

Treatments

Procedure: Thoracic paravertebral block (ThPVB)

Study type

Observational

Funder types

Other

Identifiers

NCT04414488
HL-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

119 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

119 participants in 2 patient groups

Patient controlled analgesia
Description:
General anaesthesia was induced with midazolam 0.1 mg*kg-1, propofol 2 mg*kg-1, cisatracurium 0.15 mg*kg-1 and fentanyl 1.5 µg*kg-1. Anaesthesia was maintained with one minimal alveolar concentration sevoflurane. Fractional doses of fentanyl 1-3 µg*kg-1 were administered if heart rate or mean blood pressure rose more than 20% above the base-line value obtained just before surgery commenced. After surgery, if a patient complained of pain then she/he was given i.v. oxycodone by an anaesthetist before commencing the patient controlled analgesia (PCA). The PCA solution was oxycodone (1mg*ml-1) and the PCA was programmed to allow a self-administered bolus dose of 1mg oxycodone with a lockout time of 5 min. During the night, basal rate oxycodone was 2-4 mg per hour. Additionally, patients were given 1g intravenous paracetamol every 6h and 100mg of intravenous ketoprofen every 12h, if required.
Thoracic paravertebral block and patient controlled analgesia
Description:
Before induction of general anesthesia thoracic paravertebral block was performed. General anaesthesia was induced with midazolam 0.1 mg*kg-1, propofol 2 mg*kg-1, cisatracurium 0.15 mg*kg-1 and fentanyl 1.5 µg*kg-1. Anaesthesia was maintained with one minimal alveolar concentration sevoflurane. Fractional doses of fentanyl 1-3 µg*kg-1 were administered if heart rate or mean blood pressure rose more than 20% above the base-line value obtained just before surgery commenced. After surgery, if a patient complained of pain then she/he was given i.v. oxycodone by an anaesthetist before commencing the patient controlled analgesia (PCA). The PCA solution was oxycodone (1mg*ml-1) and the PCA was programmed to allow a self-administered bolus dose of 1mg oxycodone with a lockout time of 5 min. During the night, basal rate oxycodone was 2-4 mg per hour. Additionally, patients were given 1g intravenous paracetamol every 6h and 100mg of intravenous ketoprofen every 12h, if required.
Treatment:
Procedure: Thoracic paravertebral block (ThPVB)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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