Opioid Free Anesthesia in Thoracic Surgery

Medical University of Silesia

Status: Completed

Conditions: Anesthesia, Conduction; Analgesics, Opioid; Thoracic Surgery

Treatments: Drug: Opioid Anesthesia; Drug: Opioid Free Anaesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT04355468

OPA-1

Details and patient eligibility

About

Proper assessment of pain and adequate analgesia in thoracic surgery is a challenging issue for medical practitioners. Basic aspects of thoracic anaesthesia are general anesthesia, intubation with double lumen tube and separation of lung ventilation, however proper analgesia needs to be standardized. Role of opioids in this clinical setting is reduced due to high risk of respiratory system complications. Instead, use of opioid free anaesthesia and regional anaesthesia is proposed. The aim of this study is to compare the use of opioid anaesthesia with opioid free anaesthesia and paravertebral block.

Enrollment: 66 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• body mass index between 19-30 kg/m2,
• American Society of Anesthesiology (ASA) physical status between 1 and 3

Exclusion criteria

• lack of consent
• significant coagulopathy,
• contraindication to 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

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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66 participants in 2 patient groups

Control group

Active Comparator group

Description:

General anesthesia was induced with midazolam 0.1 mg∙kg-1, propofol 2 mg∙kg-1, and cisatracurium 0.15 mg∙kg-1. The patients were intubated with a left-sided double-lumen tube in adequate size and positioned laterally. Anesthesia was maintained with 1 minimum alveolar concentration (MAC) sevoflurane. The patients awoke from anesthesia in a post-anesthesia care unit, and were extubated after the administration of adequate doses of atropine and neostigmine as required. After surgery, if a patient complained of pain then she/he was given i.v. oxycodone by an anesthetist before commencing the patient controlled analgesia (PCA). This dose was titrated to achieve adequate analgesia. Each patient then commenced PCA. The PCA solution was oxycodone (1mgml-1) and the PCA was programmed to allow a self-administered bolus dose of 1mg oxycodone with a lockout time of 5 min. Additionally, patients were given 1 g intravenous paracetamol every 6 h and 100mg of intravenous ketoprofen every 12 h.

Treatment:

Drug: Opioid Anesthesia

Opioid Free Aneasthesia group

Experimental group

Description:

General anesthesia was induced with midazolam 0.1 mg∙kg-1, propofol 2 mg∙kg-1, and cisatracurium 0.15 mg∙kg-1. The patients were intubated with a left-sided double-lumen tube in adequate size and positioned laterally. Anesthesia was maintained with 1 minimum alveolar concentration (MAC) sevoflurane. The patients awoke from anesthesia in a post-anesthesia care unit, and were extubated after the administration of adequate doses of atropine and neostigmine as required. After surgery, if a patient complained of pain then she/he was given i.v. oxycodone by an anesthetist before commencing the patient controlled analgesia (PCA). This dose was titrated to achieve adequate analgesia. Each patient then commenced PCA. The PCA solution was oxycodone (1mgml-1) and the PCA was programmed to allow a self-administered bolus dose of 1mg oxycodone with a lockout time of 5 min. Additionally, patients were given 1 g intravenous paracetamol every 6 h and 100mg of intravenous ketoprofen every 12 h.

Treatment:

Drug: Opioid Free Anaesthesia