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

NCT ID: NCT04414488

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 119 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2019-12-01

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.

Conditions

Hormones; Anesthesia, Conduction; Thoracic Surgical Procedure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient controlled analgesia

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.

No interventions assigned to this group

Thoracic paravertebral block and patient controlled analgesia

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.

Thoracic paravertebral block (ThPVB)

Intervention Type: PROCEDURE

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.

Interventions

Thoracic 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.

Intervention Type: PROCEDURE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Silesia

OTHER

Sponsor Role: lead

Responsible Party

Piotr Palaczyński

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Samodzielny Publiczny Szpital Kliniczny nr 1

Zabrze, Silesian Voivodeship, Poland

Countries

Poland

Other Identifiers

HL-01

Identifier Type: -

Identifier Source: org_study_id