Opioid Free Anesthesia in Thoracic Surgery
- Conditions
- Analgesics, OpioidAnesthesia, ConductionThoracic Surgery
- Interventions
- Drug: Opioid Free AnaesthesiaDrug: Opioid Anesthesia
- Registration Number
- NCT04355468
- Lead Sponsor
- Medical University of Silesia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- body mass index between 19-30 kg/m2,
- American Society of Anesthesiology (ASA) physical status between 1 and 3
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Opioid Free Aneasthesia group Opioid Free Anaesthesia 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. Control group Opioid Anesthesia 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.
- Primary Outcome Measures
Name Time Method Intraoperative pain related stress [oscillations per second] Period before induction of anaesthesia to termination of anaesthesia During general anesthesia the pain-related stress was assessed using a method of skin conductance fluctuations. The measurement was based on changes in skin conductance that arise under the influence of a pain stimulus.
Intraoperative opioid usage [mg] Intraoperative period Intraoperative usage of opioids was noted.
Intraoperative arterial blood pressure [mmHg] Intraoperative period Non-invasive arterial blood pressure was recorded every 5 minutes during operation.
Intraoperative heart rate [bpm] Intraoperative period Heart rate was recorded every 5 minutes during operation.
- Secondary Outcome Measures
Name Time Method Postoperative analgesic requirement [mg] 48 hours Analgesic requirement was recorded at 0, 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48 postoperative hours.
Postoperative pain intensity (PHHPS) 48 hours Pain intensity at rest was recorded with Prince Henry Hospital Pain Score (PHHPS) at 0, 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48 postoperative hours. The points in PHHPS score were assigned as below:
0. No pain during coughing.
1. Pain during coughing.
2. Pain during breathing.
3. Constant light pain.
4. Constant strong pain.Postoperative arterial blood pressure [mmHg] 48 hours Non-invasive arterial blood pressure was recorded at 0, 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48 postoperative hours.
Overall postoperative analgesia satisfaction 48 hours Overall analgesia satisfaction was recorded at 24 and 48 postoperative hours with Likert scale. The points in Likert scale were assigned as below:
1. Very satisfied.
2. Satisfied.
3. Neither satisfied nor dissatisfied.
4. Dissatisfied.
5. Very dissatisfied.Postoperative heart rate [bmp] 48 hours Heart rate was recorded at 0, 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48 postoperative hours.
Postoperative pain intensity (VAS) 48 hours Pain intensity at rest was recorded with Visual Analogue Scale (VAS) at 0, 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48 postoperative hours. Patient pointed intensity of symptoms on a 10cm ruler, where 0cm corresponded to no pain and 10cm corresponded to the strongest possible pain.
Postoperative sedation level 48 hours Sedation level was was recorded at 0, 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48 postoperative hours with Ramsay scale. The points in Ramsay scale were assigned as below:
1. Patient is anxious and agitated or restless, or both.
2. Patient is co-operative, oriented, and tranquil.
3. Patient responds to commands only.
4. Patient exhibits brisk response to light glabellar tap or loud auditory stimulus.
5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus.
6. Patient exhibits no response.
Trial Locations
- Locations (1)
Samodzielny Publiczny Szpital Kliniczny nr 1
🇵🇱Zabrze, Silesia, Poland