Clinical trial NCT05172739: Opioid Free Anaesthesia-Analgesia Strategy on Surgical Stress and Immunomodulation in Elective VATS-Lobectomy for NSCLC
Official title: Effect of a Perioperative Opioid Free Anaesthesia-Analgesia (OFA-A) Strategy on Surgical Stress Response and Immunomodulation in Elective VATS Lobectomy for NSCLC Lung Cancer: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Systemic Inflammatory Response Syndrome
Postoperative Pain, Acute
Postoperative Pain, Chronic
Infections Postoperative
Opioid Use
Anesthesia
Non-small Cell Lung Cancer
Keywords: Opioid-free Anesthesia-Analgesia
Opioid-based Anesthesia-Analgesia
Cytokines
NSCLC
Hemodynamic stability
Immunomodulation
Inflammatory markers
Acute postoperative pain
Chronic postoperative pain
Lead sponsor: University of Crete
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Administration of a multimodal anaesthetic opioid-free strategy that includes pregabalin, ketamine, dexmedetomidine, lidocaine, dexamethasone, magnesium sulphate, paracetamol and dexketoprofen is expected to affect the inflammatory and stress response, measured by levels of inflammatory markers and haemodynamic stability, when compared to conventional opioid based techniques. An Opioid-Free Anaesthesia-Analgesia strategy, is expected to also lead to an attenuated immunosuppression, due to the avoidance of opioids, whose administration has been corelated with immunosuppressive effects. An overall decreased inflammatory and stress response as expressed by reduced levels of inflammatory biomarkers and hemodynamic stability, is expected to decrease peripheral and central sensitization, contributing to better postoperative analgesia.
Primary purpose: BASIC_SCIENCE

Brief summary: Lobectomy is a major, high-risk surgical procedure that in addition to one-lung ventilation (OLV) exerts a potent surgical stress response. An overwhelming immune cell recruitment may lead to excessive tissue damage, peripheral organ injury and immunoparesis. The effect of anesthesia on the immune system is modest, compared to the effects induced by major surgery. However, to an immunocompromised patient, due to cancer and/or other comorbidities, the immunosuppressive effects of anesthesia may increase the incidence of post-operative infections, morbidity, and mortality. Exogenous opioids have been correlated with immunosuppression, opioid-induced hyperalgesia, and respiratory depression, with deleterious outcomes. An Opioid-Free Anaesthesia-Analgesia (OFA-A) strategy is based on the administration of a variety of anaesthetic/analgesic and other pharmacological agents with different mechanisms of action, including immunomodulating and anti-inflammatory effects. Our basic hypothesis is that the implementation of a perioperative multimodal OFA-A strategy, will lead to an attenuated surgical stress response and attenuated immunosuppression, compared to a conventional Opioid-Based Anaesthesia-Analgesia (OBA-A) strategy. The aforementioned effects, are presumed to be associated with equal or improved analgesia and decreased incidence of postoperative infections compared to a perioperative OBA-A technique.

Detailed description: Surgical manipulation and one lung ventilation (OLV) exert different and synergic effects to generate an inflammatory response during lung resection surgery. Surgery, such as lobectomies, often leads to severe immunosuppression that in turn can lead to infectious complications and sepsis. Both anesthesia-related and surgery-related perioperative measures may modulate the patient's immune response and lead to the activation of different components of the immune system. Anesthesia-induced activation, in particular of the adaptive immune system, may also induce persistent, postoperative immunosuppression. An overwhelming immune cell recruitment may lead to excessive tissue damage, peripheral organ injury and immunoparesis.

Opioid analgesia remains the corner stone of acute pain management in perioperative analgesic regimes. Opioid receptors are not only expressed in the central nervous system to regulate pain perception but also occur on immune and tumour cells. Exogenous opioid administration has been correlated with immunosuppression, opioid-induced hyperalgesia, and respiratory depression, with deleterious outcomes.

An Opioid-Free Anaesthesia-Analgesia (OFA-A) strategy is based on the administration of a variety of anaesthetic/analgesic and other pharmacological agents with different mechanisms of action, including immunomodulating and anti-inflammatory effects where at least one factor causes inhibition of central sensitization and at least another factor inhibits the peripheral sensitization of the nervous system, as a response to painful surgical stimuli. This combination of factors has to have a synergistic or additive effect so that best analgesic effects can be achieved with the lowest possible dosage.

Our basic hypothesis is that a perioperative OFA-A strategy on cancer patients undergoing VATS lung surgery for tumour resection will be accompanied by abolished or attenuated immunosuppression. The additional potential clinical implication of a perioperative OFA-A strategy is the avoidance of the onco-proliferative side effects of both exogenous and endogenous opioids, released by cytokine-mediated immune cell activation. Inflammatory response inhibition is expected to reduce the possibility of acute and chronic post-operative pain developement, compared to a perioperative Opioid-Based Anaesthesia- Analgesia (OBA-A) technique. Additionally, the aforementioned inflammatory response inhibition is expected to lead to an overall reduction of overall postoperative pulmonary complications.

Eligibility criteria: Inclusion Criteria:

* patients undergoing elective VATS lobectomy
* early stage NSCLC (up to T3N1M0)

Exclusion Criteria:

* Immunocompromised patients
* previous lung surgery
* preoperative corticosteroid or immunosuppressive drug use
* uncontrolled Diabetes Mellitus
* cardiac failure (NYHA 3 and 4)
* preoperative infection (CRP \>5mg/ml, WBC \>10x10\^9/L)
* preoperative anemia (Hb\<12g/dl)
* chronic inflammatory diseases
* inflammatory bowel disease

Group-specific exclusion criteria:

* OFA-Α: perioperative opioid administration, within the study period
* OBA-Α: perioperative dexmedetomidine or lidocaine infusion, ketamine, gabapentinoid or corticosteroid administration within the study period

Primary outcomes:
measure: Neutrophil to Lymphocyte ratio (NLR)
timeFrame: Preoperatively
measure: Platelet to Lymphocyte ratio (PLR)
timeFrame: Preoperatively
measure: Lymphocyte to monocyte ratio (LMR)
timeFrame: Preoperatively
measure: Advanced Lung Cancer Inflammation Index (ALI)
timeFrame: Preoperatively
measure: Systemic Immune Inflammation Index (SII)
timeFrame: Preoperatively
measure: Prognostic Nutritional Index (PNI)
timeFrame: Preoperatively
measure: Surgical Stress Response - IL-6 - preoperatively
timeFrame: Preoperatively (as a baseline)
measure: Surgical Stress Response - IL-6 - end of surgery
timeFrame: End of surgery (end of placement of last suture/ surgical clip on patient)
measure: Surgical Stress Response - IL-6 - 24 hours after the end of surgery
timeFrame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
measure: Surgical Stress Response - IL-8 - preoperatively
timeFrame: Preoperatively (as a baseline)
measure: Surgical Stress Response - IL-8 - end of surgery
timeFrame: End of surgery (end of placement of last suture/ surgical clip on patient)
measure: Surgical Stress Response - IL-8 - 24 hours after the end of surgery
timeFrame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
measure: Surgical Stress Response - IL-10 - preoperatively
timeFrame: Preoperatively (as a baseline)
measure: Surgical Stress Response - IL-10 - end of surgery
timeFrame: End of surgery (end of placement of last suture/ surgical clip on patient)
measure: Surgical Stress Response - IL-10 - 24 hours after the end of surgery
timeFrame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
measure: Surgical Stress Response - TNF-a - preoperatively
timeFrame: Preoperatively (as a baseline)
measure: Surgical Stress Response - TNF-a - end of surgery
timeFrame: End of surgery (end of placement of last suture/ surgical clip on patient)
measure: Surgical Stress Response - TNF-a - 24 hours after the end of surgery
timeFrame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
measure: Surgical Stress Response - CRP - preoperatively
timeFrame: Preoperatively (as a baseline)
measure: Surgical Stress Response - CRP - end of surgery
timeFrame: End of surgery (end of placement of last suture/ surgical clip on patient)
measure: Surgical Stress Response - CRP - 24 hours after the end of surgery
timeFrame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
measure: Surgical Stress Response - WBC - preoperatively
timeFrame: Preoperatively (as a baseline)
measure: Surgical Stress Response - WBC - end of surgery
timeFrame: End of surgery (end of placement of last suture/ surgical clip on patient)
measure: Surgical Stress Response - WBC - 24 hours after the end of surgery
timeFrame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
measure: Surgical Stress Response - AVP - preoperatively
timeFrame: Preoperatively (as a baseline)
measure: Surgical Stress Response - AVP - end of surgery
timeFrame: End of surgery (end of placement of last suture/ surgical clip on patient)
measure: Surgical Stress Response - AVP - 24 hours after the end of surgery
timeFrame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
measure: Surgical Stress Response - cortisol - preoperatively
timeFrame: Preoperatively (as a baseline)
measure: Surgical Stress Response - cortisol - end of surgery
timeFrame: End of surgery (end of placement of last suture/ surgical clip on patient)
measure: Surgical Stress Response - cortisol - 24 hours after the end of surgery
timeFrame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
measure: Surgical Stress Response - HIF-1α- preoperatively
timeFrame: Preoperatively (as a baseline)
measure: Surgical Stress Response - HIF-1α - end of surgery
timeFrame: End of surgery (end of placement of last suture/ surgical clip on patient)
measure: Surgical Stress Response - HIF-1α - 24 hours after the end of surgery
timeFrame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
measure: Surgical Stress Response - VEGF- preoperatively
timeFrame: Preoperatively (as a baseline)
measure: Surgical Stress Response - VEGF- end of surgery
timeFrame: End of surgery (end of placement of last suture/ surgical clip on patient)
measure: Surgical Stress Response - VEGF - 24 hours after the end of surgery
timeFrame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
measure: Surgical Stress Response - NF-κB - preoperatively
timeFrame: Preoperatively (as a baseline)
measure: Surgical Stress Response - NF-κB - end of surgery
timeFrame: End of surgery (end of placement of last suture/ surgical clip on patient)
measure: Surgical Stress Response - NF-κB - 24 hours after the end of surgery
timeFrame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
measure: Haemodynamic Stability - Mean PR
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Minimum PR
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Maximum PR
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Standard Deviation PR
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - PR Change Induction
timeFrame: 1 minute after anesthesia induction, compared to 1 minute prior
measure: Haemodynamic Stability - PR Change Incision
timeFrame: 1 minute after surgical incision, compared to 1 minute prior
measure: Haemodynamic Stability - Mean SBP
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Minimum SBP
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Maximum SBP
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Standard Deviation SBP
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - SBP Change Induction
timeFrame: 1 minute after anesthesia induction, compared to 1 minute prior
measure: Haemodynamic Stability - SBP Change Incision
timeFrame: 1 minute after surgical incision, compared to 1 minute prior
measure: Haemodynamic Stability - Mean DBP
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Minimum DBP
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Maximum DBP
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Standard Deviation DBP
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - DBP change induction
timeFrame: 1 minute after anesthesia induction, compared to 1 minute prior
measure: Haemodynamic Stability - DBP change incision
timeFrame: 1 minute after surgical incision, compared to 1 minute prior
measure: Haemodynamic Stability - Mean MBP
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Minimum MBP
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Maximum MBP
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Standard Deviation MBP
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - MBP change induction
timeFrame: 1 minute after anesthesia induction, compared to 1 minute prior
measure: Haemodynamic Stability - MBP change incision
timeFrame: 1 minute after surgical incision, compared to 1 minute prior
measure: Haemodynamic Stability - Mean CO
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Minimum CO
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Maximum CO
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Standard Deviation CO
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Mean CI
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Minimum CI
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Maximum CI
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Standard Deviation CI
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Mean SV
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Minimum SV
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Maximum SV
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Standard Deviation SV
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Mean SVV
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Minimum SVV
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Maximum SVV
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Standard Deviation SVV
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Mean SVI
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Minimum SVI
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Maximum SVI
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Standard Deviation SVI
timeFrame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
measure: Haemodynamic Stability - Tachycardia
timeFrame: Intraoperatively, assessed up to 4 hours.
measure: Haemodynamic Stability - Bradycardia
timeFrame: Intraoperatively, assessed up to 4 hours.
measure: Haemodynamic Stability - Hypotension
timeFrame: Intraoperatively, assessed up to 6 hours.
measure: Haemodynamic Stability - Hypertension
timeFrame: Intraoperatively, assessed up to 6 hours.
measure: Haemodynamic Stability - Fluid requirements - Crystalloids - Intraoperatively
timeFrame: Intraoperatively, assessed up to 6 hours.
measure: Haemodynamic Stability - Fluid requirements - Colloids - Intraoperatively
timeFrame: Intraoperatively, assessed up to 6 hours.
measure: Haemodynamic Stability - Fluid requirements - Concentrated RBCs - Intraoperatively
timeFrame: Intraoperatively, assessed up to 6 hours.
measure: Haemodynamic Stability - Fluid requirements - Plasma - Intraoperatively
timeFrame: Intraoperatively, assessed up to 6 hours.
measure: Haemodynamic Stability - Fluid requirements - Platelets - Intraoperatively
timeFrame: Intraoperatively, assessed up to 6 hours.
measure: Haemodynamic Stability - Blood Loss - Intraoperatively
timeFrame: Intraoperatively, assessed up to 6 hours.
measure: Haemodynamic Stability - Fluid Balance - Intraoperatively
timeFrame: Intraoperatively, assessed up to 6 hours.
measure: Haemodynamic Stability - Vasoactive Requirements - Adrenaline - Intraoperatively
timeFrame: Intraoperatively, assessed up to 6 hours.
measure: Haemodynamic Stability - Vasoactive Requirements - Noradrenaline - Intraoperatively
timeFrame: Intraoperatively, assessed up to 6 hours.
measure: Haemodynamic Stability - Vasoactive Requirements - Ephedrine - Intraoperatively
timeFrame: Intraoperatively, assessed up to 6 hours.
measure: Haemodynamic Stability - Vasoactive Requirements - Phenylephrine - Intraoperatively
timeFrame: Intraoperatively, assessed up to 6 hours.
measure: Haemodynamic Stability - Vasoactive Requirements - Dopamine - Intraoperatively
timeFrame: Intraoperatively, assessed up to 6 hours.
measure: Haemodynamic Stability - Vasoactive Requirements - Dobutamine - Intraoperatively
timeFrame: Intraoperatively, assessed up to 6 hours.
measure: Haemodynamic Stability - Vasoactive Requirements - Nitroglycerine - Intraoperatively
timeFrame: Intraoperatively, assessed up to 6 hours.
Secondary outcomes:
measure: Acute postoperative pain - Numerical Rating Scale (NRS) - Immediately Postoperatively
timeFrame: Immediately postoperatively
measure: Acute postoperative pain - Numerical Rating Scale (NRS) - First postoperative day
timeFrame: First postoperative day
measure: Acute postoperative pain - Numerical Rating Scale (NRS) - Second postoperative day
timeFrame: Second postoperative day
measure: Acute postoperative pain - Numerical Rating Scale (NRS) - Third postoperative day
timeFrame: Third postoperative day
measure: Acute postoperative pain - Critical Care Pain Observation Tool (CPOT) - Immediately Postoperatively
timeFrame: Immediately postoperatively
measure: Acute postoperative pain - Critical Care Pain Observation Tool (CPOT) - First postoperative day
timeFrame: First postoperative day
measure: Acute postoperative pain - Critical Care Pain Observation Tool (CPOT) - Second postoperative day
timeFrame: Second postoperative day
measure: Acute postoperative pain - Critical Care Pain Observation Tool (CPOT) - Third postoperative day
timeFrame: Third postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - First postoperative day
timeFrame: First postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - Second postoperative day
timeFrame: Second postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - Third postoperative day
timeFrame: Third postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - First postoperative day
timeFrame: First postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - Second postoperative day
timeFrame: Second postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - Third postoperative day
timeFrame: Third postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - First postoperative day
timeFrame: First postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - Second postoperative day
timeFrame: Second postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - Third postoperative day
timeFrame: Third postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - First postoperative day
timeFrame: First postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - Second postoperative day
timeFrame: Second postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - Third postoperative day
timeFrame: Third postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - First postoperative day
timeFrame: First postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - Second postoperative day
timeFrame: Second postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - Third postoperative day
timeFrame: Third postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - First postoperative day
timeFrame: First postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - Second postoperative day
timeFrame: Second postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - Third postoperative day
timeFrame: Third postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - First postoperative day
timeFrame: First postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - Second postoperative day
timeFrame: Second postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - Third postoperative day
timeFrame: Third postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - First postoperative day
timeFrame: First postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - Second postoperative day
timeFrame: Second postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - Third postoperative day
timeFrame: Third postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - First postoperative day
timeFrame: First postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - Second postoperative day
timeFrame: Second postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - Third postoperative day
timeFrame: Third postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - First postoperative day
timeFrame: First postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - Second postoperative day
timeFrame: Second postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - Third postoperative day
timeFrame: Third postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - First postoperative day
timeFrame: First postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - Second postoperative day
timeFrame: Second postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - Third postoperative day
timeFrame: Third postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Pain keeps me from doing most of what I need to do - First postoperative day
timeFrame: First postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Pain keeps me from doing most of what I need to do - Second postoperative day
timeFrame: Second postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Pain keeps me from doing most of what I need to do - Third postoperative day
timeFrame: Third postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do most things, but pain gets in the way of some - First postoperative day
timeFrame: First postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do most things, but pain gets in the way of some - Second postoperative day
timeFrame: Second postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do most things, but pain gets in the way of some - Third postoperative day
timeFrame: Third postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - First postoperative day
timeFrame: First postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - Second postoperative day
timeFrame: Second postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - Third postoperative day
timeFrame: Third postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - First postoperative day
timeFrame: First postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - Second postoperative day
timeFrame: Second postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - Third postoperative day
timeFrame: Third postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - First postoperative day
timeFrame: First postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - Second postoperative day
timeFrame: Second postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - Third postoperative day
timeFrame: Third postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - First postoperative day
timeFrame: First postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - Second postoperative day
timeFrame: Second postoperative day
measure: Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - Third postoperative day
timeFrame: Third postoperative day
measure: Analgesic Requirements - First postoperative day
timeFrame: First postoperative day
measure: Analgesic Requirements - Second postoperative day
timeFrame: Second postoperative day
measure: Analgesic Requirements - Third postoperative day
timeFrame: Third postoperative day
measure: Postoperative Pulmonary Complications - Aspiration Pneumonitis
timeFrame: From the first postoperative day, until the fifth postoperative day
measure: Postoperative Pulmonary Complications - Moderate respiratory failure
timeFrame: From the first postoperative day, until the fifth postoperative day
measure: Postoperative Pulmonary Complications - Severe respiratory failure
timeFrame: From the first postoperative day, until the fifth postoperative day
measure: Postoperative Pulmonary Complications - ARDS
timeFrame: From the first postoperative day, until the fifth postoperative day
measure: Postoperative Pulmonary Complications - Pulmonary Infection
timeFrame: From the first postoperative day, until the fifth postoperative day
measure: Postoperative Pulmonary Complications - Atelectasis
timeFrame: From the first postoperative day, until the fifth postoperative day
measure: Postoperative Pulmonary Complications - Cardiopulmonary edema
timeFrame: From the first postoperative day, until the fifth postoperative day
measure: Postoperative Pulmonary Complications - Pleural effusion
timeFrame: From the first postoperative day, until the fifth postoperative day
measure: Postoperative Pulmonary Complications - Pneumothorax
timeFrame: From the first postoperative day, until the fifth postoperative day
measure: Postoperative Pulmonary Complications - Pulmonary Infiltrates
timeFrame: From the first postoperative day, until the fifth postoperative day
measure: Postoperative Pulmonary Complications - Prolonged air leakage
timeFrame: From the first postoperative day, until the fifth postoperative day
measure: Postoperative Pulmonary Complications - Purulent pleuritic
timeFrame: From the first postoperative day, until the fifth postoperative day
measure: Postoperative Pulmonary Complications - Pulmonary embolism
timeFrame: From the first postoperative day, until the fifth postoperative day
measure: Postoperative Pulmonary Complications - Lung hemorrhage
timeFrame: From the first postoperative day, until the fifth postoperative day
measure: Chronic postoperative pain - Pain Detect
timeFrame: Three months after the end of surgery
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: University of Crete
state: Crete
Study officials:
affiliation: University of Crete, Medical school
name: Vasileia Nyktari, MD, PhD
role: STUDY_CHAIR
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