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

NCT04414488 | Completed

• 1 other identifier: HL-01
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Hormones; Anesthesia, Conduction; Thoracic Surgical Procedure

Outcome Measures

Primary Outcomes (8)

• Alpha-amylase activity. [U/ml]

  α-amylase activity assay was performed by a static method with AMYLAZA kit (Aqua-Med Łodz, Poland). The samples were diluted 100 times using 0,9% chloride solution. 2-chloro-4-nitrofenylo-maltotrioside is a substrate in this method. The reaction was performed in pH 6,0 MES buffer at 37 ° C rendering a colored reaction product. The product was then analyzed via spectrophotometry at 405 nm. Results are presented in salivary α-amylase activity units (U/ml). Measurement imprecision of the method was 4.1%. Material was collected after enrollment to the study (T0), six hours after the surgery (T1) and 24 hours after the surgery (T2).

  24 hours

• Cortisol concentration. [ng/ml]

  The commercial ELISA (Diapra, Italy) was used to determine the concentration of cortisol. The analytical procedure was in accordance with the manufacturer's instructions in the technical manuals supplied with the kits. Absorbance readings were taken using a µQuant reader (Biotek, USA), while results were processed using KCJunior (Biotek, USA). The sensitivity of the method was 0,12 ng/ml for cortisol. The method's imprecision was 6.2%. Material was collected after enrollment to the study (T0), six hours after the surgery (T1) and 24 hours after the surgery (T2).

  24 hours

• Testosterone concentration. [pg/ml]

  The commercial ELISA (Diapra, Italy) was used to determine the concentration of testosterone. The analytical procedure was in accordance with the manufacturer's instructions in the technical manuals supplied with the kits. Absorbance readings were taken using a µQuant reader (Biotek, USA), while results were processed using KCJunior (Biotek, USA). The sensitivity of the method was 3,28 pg/ml for testosterone. The method's imprecision was 7.9%. Material was collected after enrollment to the study (T0), six hours after the surgery (T1) and 24 hours after the surgery (T2).

  24 hours

• Secretory Immunoglobulin A concentration. (sIgA)

  The commercial ELISA (Immunodiagnostic AG, Niemcy.) were used to determine the concentration of sIgA. The analytical procedure was in accordance with the manufacturer's instructions in the technical manuals supplied with the kits. Absorbance readings were taken using a µQuant reader (Biotek, USA), while results were processed using KCJunior (Biotek, USA). Material was collected after enrollment to the study (T0), six hours after the surgery (T1) and 24 hours after the surgery (T2).

  24 hours

• β-endorphin concentration.

  Determination of β-endorphin concentration was preceded by extraction on C18 Sep-Pak columns containing 50mg C18, using trifluoroacetic acid (TFA) and elution buffer (i.e. 60% acetonitrile, 1% TFA and 39% distilled water). The extracts obtained were lyophilized. To determine the concentration of β-endorphins in the tested samples, lyophilisates were dissolved in an appropriate amount of buffer, and then commercial ELISA tests from Elabscience, USA were used. The analytical procedure was in accordance with the manufacturer's instructions in the technical manuals supplied with the kits. Absorbance readings were taken using a µQuant reader (Biotek, USA), while results were processed using KCJunior (Biotek, USA). Material was collected after enrollment to the study (T0), six hours after the surgery (T1) and 24 hours after the surgery (T2).

  24 hours

• P substance concentration. [pg/ml]

  The commercial ELISA test was used to determine the concentration of P substance. The analytical procedure was in accordance with the manufacturer's instructions in the technical manuals supplied with the kits. Material was collected after enrollment to the study (T0), six hours after the surgery (T1) and 24 hours after the surgery (T2).

  24 hours

• Nerve Growth Factor concentration. [ng/ml]

  The commercial ELISA test was used to determine the concentration of the Nerve Growth Factor. The analytical procedure was in accordance with the manufacturer's instructions in the technical manuals supplied with the kits. Material was collected after enrollment to the study (T0), six hours after the surgery (T1) and 24 hours after the surgery (T2).

  24 hours

• Calcitonin Gene-related Peptide concentration. [pg/ml]

  The commercial ELISA test was used to determine the concentration of the Calcitonin Gene-related Peptide. The analytical procedure was in accordance with the manufacturer's instructions in the technical manuals supplied with the kits. Material was collected after enrollment to the study (T0), six hours after the surgery (T1) and 24 hours after the surgery (T2).

  24 hours

Secondary Outcomes (4)

• Pain intensity (NRS)

  24 hours

• Arterial blood pressure [mmHg]

  24 hours

• Heart rate [bmp]

  24 hours

• Arterial blood saturation measured by pulse oximetry [%]

  24 hours

Study Arms (2)

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.

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.

Procedure: Thoracic paravertebral block (ThPVB)

Interventions

Thoracic paravertebral block (ThPVB) 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.

Thoracic paravertebral block and patient controlled analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population consisted of consecutive patients scheduled for elective videothoracoscopic procedures.

You may qualify if:

• qualification to elective videothoracoscopic procedures and general anaesthesia

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (1)

Samodzielny Publiczny Szpital Kliniczny nr 1

Zabrze, Silesian Voivodeship, 41-800, Poland

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2020
• First Posted: June 4, 2020
• Study Start: May 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 4, 2020

Record last verified: 2020-05

Locations

PL (1)