Opioid Free Anesthesia in Thoracic Surgery

NCT ID: NCT04355468

Last Updated: 2022-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2018-03-31

Brief Summary

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.

Conditions

Thoracic Surgery; Analgesics, Opioid; Anesthesia, Conduction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

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.

Group Type: ACTIVE_COMPARATOR

Opioid Anesthesia

Intervention Type: DRUG

Intraoperatively, fentanyl in fractional doses of 1-3 µg∙kg-1 were applied if the heart rate (HR; Heart Rate) or mean blood pressure (MBP; Mean Blood Pressure) increased by more than 20% above the baseline value obtained just before surgery commencement.

Opioid Free Aneasthesia group

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.

Group Type: EXPERIMENTAL

Opioid Free Anaesthesia

Intervention Type: DRUG

Before the induction of general anesthesia, a single-shot thoracic paravertebral block (ThPVB) was performed at the Th3-Th4 level. An insulated needle was used, connected to a peripheral nerve stimulator. 0.5% bupivacaine (0.3 ml∙kg-1) was then injected after a negative aspiration test. The efficacy of the blockade was checked after 20 min on both sides of the thorax with a plastic ampoule of saline. A difference in the sensation of cold between the sides of the thorax was assumed to indicate an effective block. Afterwards a continuous intravenous infusion of lidocaine and ketamine was started:

1. immediately after anesthesia induction, lidocaine was administered as an i.v. bolus at a dose of 1.5 mg∙kg-1 and ketamine in an i.v. bolus of 0.35 mg∙kg-1;

2. followed by an infusion of lidocaine 2.0 mg∙kg-1∙h-1 for 2 hours, continued at a dose of 1.2 mg∙kg-1∙h-1, and ketamine infusion 0.2 mg∙kg-1∙h-1 for 2 hours, continued at a dose of 0.12 mg∙kg-1∙h-1.

Interventions

Opioid Anesthesia

Intraoperatively, fentanyl in fractional doses of 1-3 µg∙kg-1 were applied if the heart rate (HR; Heart Rate) or mean blood pressure (MBP; Mean Blood Pressure) increased by more than 20% above the baseline value obtained just before surgery commencement.

Intervention Type: DRUG

Opioid Free Anaesthesia

Before the induction of general anesthesia, a single-shot thoracic paravertebral block (ThPVB) was performed at the Th3-Th4 level. An insulated needle was used, connected to a peripheral nerve stimulator. 0.5% bupivacaine (0.3 ml∙kg-1) was then injected after a negative aspiration test. The efficacy of the blockade was checked after 20 min on both sides of the thorax with a plastic ampoule of saline. A difference in the sensation of cold between the sides of the thorax was assumed to indicate an effective block. Afterwards a continuous intravenous infusion of lidocaine and ketamine was started:

1. immediately after anesthesia induction, lidocaine was administered as an i.v. bolus at a dose of 1.5 mg∙kg-1 and ketamine in an i.v. bolus of 0.35 mg∙kg-1;

2. followed by an infusion of lidocaine 2.0 mg∙kg-1∙h-1 for 2 hours, continued at a dose of 1.2 mg∙kg-1∙h-1, and ketamine infusion 0.2 mg∙kg-1∙h-1 for 2 hours, continued at a dose of 0.12 mg∙kg-1∙h-1.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 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

OPA-1

Identifier Type: -

Identifier Source: org_study_id