Thoracic Surgery Clinical Trial
Official title:
Opioid-free Anaesthesia Effectiveness in Thoracic Surgery - Objective Measurement With a Skin Conductance Algesimeter: a Randomized Controlled Trial
NCT number | NCT04355468 |
Other study ID # | OPA-1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2015 |
Est. completion date | March 2018 |
Verified date | October 2022 |
Source | Medical University of Silesia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | March 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Poland | Samodzielny Publiczny Szpital Kliniczny nr 1 | Zabrze | Silesia |
Lead Sponsor | Collaborator |
---|---|
Medical University of Silesia |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intraoperative pain related stress [oscillations per second] | 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. | Period before induction of anaesthesia to termination of anaesthesia | |
Primary | Intraoperative opioid usage [mg] | Intraoperative usage of opioids was noted. | Intraoperative period | |
Primary | Intraoperative arterial blood pressure [mmHg] | Non-invasive arterial blood pressure was recorded every 5 minutes during operation. | Intraoperative period | |
Primary | Intraoperative heart rate [bpm] | Heart rate was recorded every 5 minutes during operation. | Intraoperative period | |
Secondary | Overall postoperative analgesia satisfaction | Overall analgesia satisfaction was recorded at 24 and 48 postoperative hours with Likert scale. The points in Likert scale were assigned as below:
Very satisfied. Satisfied. Neither satisfied nor dissatisfied. Dissatisfied. Very dissatisfied. |
48 hours | |
Secondary | Postoperative pain intensity (VAS) | 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. | 48 hours | |
Secondary | Postoperative pain intensity (PHHPS) | 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. Pain during coughing. Pain during breathing. Constant light pain. Constant strong pain. |
48 hours | |
Secondary | Postoperative arterial blood pressure [mmHg] | Non-invasive arterial blood pressure was recorded at 0, 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48 postoperative hours. | 48 hours | |
Secondary | Postoperative heart rate [bmp] | Heart rate was recorded at 0, 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48 postoperative hours. | 48 hours | |
Secondary | Postoperative sedation level | 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:
Patient is anxious and agitated or restless, or both. Patient is co-operative, oriented, and tranquil. Patient responds to commands only. Patient exhibits brisk response to light glabellar tap or loud auditory stimulus. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus. Patient exhibits no response. |
48 hours | |
Secondary | Postoperative analgesic requirement [mg] | Analgesic requirement was recorded at 0, 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48 postoperative hours. | 48 hours |
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