Clinical trial NCT04894864: Opioid Free Anesthesia-Analgesia Strategy and Surgical Stress in Elective Open Abdominal Aortic Aneurysm Repair
Official title: Effect of a Perioperative Opioid Free Anesthesia-Analgesia (OFA-A) Strategy on Surgical Stress Response in Elective Open Abdominal Aortic Aneurysm Repair: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Elective Surgical Procedures
Postoperative Pain
Anesthesia
Opioid Use
Abdominal Aortic Aneurysm Without Rupture
Vascular Surgical Procedure
Interleukin 6
Immunomodulators
Keywords: Opioid-free Anesthesia-Analgesia
Cytokines
Opioid-based Anesthesia-Analgesia
Haemodynamic Stability
Open Abdominal Aortic Aneurysm Repair
Immunomodulation
Inflammatory Markers
Lead sponsor: University of Crete
Sponsor class: OTHER
Collaborators: name: University Hospital of Crete
First posted: 2021-05-20
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Implementation of a multimodal anesthetic opioid-free strategy, that includes the administration of pregabalin, ketamine, dexmedetomidine, lidocaine, dexamethasone, magnesium sulphate, paracetamol and dexketoprofen is anticipated to modulate the inflammatory and stress response, as measured by levels of inflammatory markers and haemodynamic stability, compared to conventional anesthetic opioid-based techniques. Furthermore, a 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: Open Abdominal Aortic Aneurysm (AAA) repair is a high-risk surgical procedure accompanied by intense endocrine and metabolic responses to surgical stress, with subsequent activation of the inflammatory cascade, cytokine and acute-phase protein release, and bone marrow activation. There is a proven correlation of surgical stress, which patients undergoing open AAA repair are subjected to, with patient outcome, morbidity/mortality, intensive care unit stay and overall length of stay. Modern general anesthetic techniques have been revised and rely on perioperative multimodal anesthetic and analgesic strategies for improved overall patient outcome. Based on this context of a multimodal anesthetic technique and having taken into consideration the international "opioid-crisis" epidemic, an Opioid Free Anesthesia-Analgesia (OFA-A) strategy started to emerge. It is based on the administration of a variety of anesthetic/analgesic 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, involving the administration of pregabalin, ketamine, dexmedetomidine, lidocaine, dexamethasone, dexketoprofen, paracetamol and magnesium sulphate, will lead to attenuation of surgical stress response compared to a conventional Opioid-Based Anesthesia-Analgesia (OBA-A) strategy. Furthermore, the anticipated attenuation of the inflammatory response, is pressumed to be associated with equal or improved analgesia, compared to a perioperative OBA-A technique.

Detailed description: Open abdominal aortic aneurysm (AAA) repair surgery is a high-risk operation, often performed on high-risk patients. Despite advancements made in diagnosis, management, surgical techniques and treatment of these patients, morbidity and mortality remain high. Mortality after open AAA repair remains higher than the average mortality of the matched population for age and sex. Debate is ongoing as to whether open AAA repair or endovascular aneurysm repair (EVAR) is better in terms of overall long-term survival rate.

Regarding open AAA repair, the very nature of the surgery itself, with surgical trauma, aortic cross clamping and its resulting ischemia-reperfusion injury, and cellular interactions of blood with the biomaterial surface of the graft, causes intense and varied metabolic, endocrine and immunological responses. These surgical stress-related responses are evident as marked increases in inflammatory cytokines such as TNF-a, IL-1a, IL-6, IL-8, IL-10, stimulation of the sympathetic system, and stimulation of the hypothalamic-pituitary-adrenal axis, caused by release of CRH and AVP. High levels of IL-6, peaking at 4-48h after clamp removal, have been associated with serious postoperative complications and its levels reflect the intensity of surgical trauma following AAA repair. Other inflammation markers such as CRP and leukocytes have also been shown to increase postoperatively.

While the surgical technique has been extensively studied as to the role it plays on the control of the surgical stress response, patient outcome, morbidity and overall mortality, fewer studies have been conducted to study the effect of the anesthetic management on these factors. While most of them have been focusing on the comparison of general anesthetic vs regional techniques, only few compare different general anesthetic techniques on patient outcome.

Modern general anesthetic techniques have been revised and rely on a multimodal anesthetic and analgesic perioperative regimen for improved patient outcome. A multimodal regimen requires the administration of at least 2 factors with different mechanisms of action. At least one factor causes inhibition of central sensitization and at least another one inhibits the peripheral sensitization of the nervous system, as a response to painful surgical stimuli, mitigating adverse neuroplasticity. One such example, is an Opioid-Free Anesthetic-Analgesic (OFA-A) strategy, which implements a variety of pharmacological agents, including some with demonstrated immunomodulating and anti-inflammatory effects. Apart from sparing any opioid-related adverse effects, an OFA-A multimodal strategy targets optimal analgesia with a multitude of factors in the lowest possible dose, aiming for additive or synergistic effects. An additional advantage of using an OFA-A technique is the prevention of opioid-induced hyperalgesia.

Our hypothesis is that implementation of a multimodal OFA-A strategy, leads to a decreased sympathetic and inflammatory response, compared to conventional opioid-based anesthetic techniques. A decreased inflammatory and stress response as expressed by reduced levels of IL-6, IL-8, IL-10, TNF-a, CRP, cortisol, arginine vasopressin (AVP), white blood cells count and hemodynamic stability is expected to decrease peripheral and central sensitization, contributing to better postoperative analgesia.

Eligibility criteria: Inclusion Criteria:

1. Patient Consent
2. Age between 40 and 85 years old
3. Patients undergoing Elective Open Abdominal Aortic Infrarenal Aneurysm Repair

Exclusion Criteria:

1. Immunocompromised patients
2. Patients with active infection
3. Reoperation on the aorta
4. Inflammatory bowel Disease
5. Malignancy
6. Chronic Inflammatory conditions (e.g. Rheymatoid arthritis, Psoriatic arthritis)
7. Chronic corticosteroid or immunosuppressive drug use
8. Intraoperative transfusion with \>2 units of packed Red Blood Cells

Primary outcomes:
measure: Surgical Stress Response - IL-6 - Preoperatively
timeFrame: 1) Preoperatively (as a baseline)
measure: Surgical Stress Response - IL-6 - 15 minutes after aortic cross-clamp
timeFrame: 2) 15 minutes after aortic cross-clamping
measure: Surgical Stress Response - IL-6 - 60 minutes after aortic cross-clamp
timeFrame: 3) 60 minutes after aortic cross-clamp release
measure: Surgical Stress Response - IL-6 - 24 hours after aortic cross-clamp release
timeFrame: 4) 24 hours after aortic cross-clamp release
measure: Surgical Stress Response - IL-8 - Preoperatively
timeFrame: 1) Preoperatively (as a baseline)
measure: Surgical Stress Response - IL-8 - 15 minutes after aortic cross-clamp
timeFrame: 2) 15 minutes after aortic cross-clamping
measure: Surgical Stress Response - IL-8 - 60 minutes after aortic cross-clamp
timeFrame: 3) 60 minutes after aortic cross-clamp release
measure: Surgical Stress Response - IL-8 - 24 hours after aortic cross-clamp release
timeFrame: 4) 24 hours after aortic cross-clamp release
measure: Surgical Stress Response - IL-10 - Preoperatively
timeFrame: 1) Preoperatively (as a baseline)
measure: Surgical Stress Response - IL-10 - 15 minutes after aortic cross-clamp
timeFrame: 2) 15 minutes after aortic cross-clamping
measure: Surgical Stress Response - IL-10 - 60 minutes after aortic cross-clamp
timeFrame: 3) 60 minutes after aortic cross-clamp release
measure: Surgical Stress Response - IL-10 - 24 hours after aortic cross-clamp release
timeFrame: 4) 24 hours after aortic cross-clamp release
measure: Surgical Stress Response - AVP - Preoperatively
timeFrame: 1) Preoperatively (as a baseline)
measure: Surgical Stress Response - AVP - 15 minutes after aortic cross-clamp
timeFrame: 2) 15 minutes after aortic cross-clamping
measure: Surgical Stress Response - AVP - 60 minutes after aortic cross-clamp
timeFrame: 3) 60 minutes after aortic cross-clamp release
measure: Surgical Stress Response - AVP - 24 hours after aortic cross-clamp release
timeFrame: 4) 24 hours after aortic cross-clamp release
measure: Surgical Stress Response - TNF-a - Preoperatively
timeFrame: 1) Preoperatively (as a baseline)
measure: Surgical Stress Response - TNF-a - 15 minutes after aortic cross-clamp
timeFrame: 2) 15 minutes after aortic cross-clamping
measure: Surgical Stress Response - TNF-a - 60 minutes after aortic cross-clamp
timeFrame: 3) 60 minutes after aortic cross-clamp release
measure: Surgical Stress Response - TNF-a - 24 hours after aortic cross-clamp release
timeFrame: 4) 24 hours after aortic cross-clamp release
measure: Surgical Stress Response - Cortisol - Preoperatively
timeFrame: 1) Preoperatively (as a baseline)
measure: Surgical Stress Response - Cortisol - 15 minutes after aortic cross-clamp
timeFrame: 2) 15 minutes after aortic cross-clamping
measure: Surgical Stress Response - Cortisol - 60 minutes after aortic cross-clamp
timeFrame: 3) 60 minutes after aortic cross-clamp release
measure: Surgical Stress Response - Cortisol - 24 hours after aortic cross-clamp release
timeFrame: 4) 24 hours after aortic cross-clamp release
measure: Surgical Stress Response - CRP - Preoperatively
timeFrame: 1) Preoperatively (as a baseline)
measure: Surgical Stress Response - CRP - 15 minutes after aortic cross-clamp
timeFrame: 2) 15 minutes after aortic cross-clamping
measure: Surgical Stress Response - CRP - 60 minutes after aortic cross-clamp
timeFrame: 3) 60 minutes after aortic cross-clamp release
measure: Surgical Stress Response - CRP - 24 hours after aortic cross-clamp release
timeFrame: 4) 24 hours after aortic cross-clamp release
measure: Surgical Stress Response - WBC - Preoperatively
timeFrame: 1) Preoperatively (as a baseline)
measure: Surgical Stress Response - WBC - 15 minutes after aortic cross-clamp
timeFrame: 2) 15 minutes after aortic cross-clamping
measure: Surgical Stress Response - WBC - 60 minutes after aortic cross-clamp
timeFrame: 3) 60 minutes after aortic cross-clamp release
measure: Surgical Stress Response - WBC - 24 hours after aortic cross-clamp release
timeFrame: 4) 24 hours after aortic cross-clamp release
measure: Haemodynamic Stability - Coefficient of Variation 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 - Average Real Variability PR
timeFrame: Every minute 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 - Coefficient of Variation 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 - Average Real Variability SBP
timeFrame: Every minute 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 - Coefficient of Variation 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 - Average Real Variability DBP
timeFrame: Every minute 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 - Coefficient of Variation 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 - Average Real Variability MBP
timeFrame: Every minute 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 - Coefficient of Variation PP
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 - Average Real Variability PP
timeFrame: Every minute 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: 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 - Bradycardia
timeFrame: 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 - Hypotension SBP
timeFrame: Baseline: 5 minutes prior to anaesthesia induction. Intraoperative Hypotension: 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 - Hypotension MBP
timeFrame: Baseline: 5 minutes prior to anaesthesia induction. Intraoperative Hypotension: 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 - Hypertension
timeFrame: Baseline: 5 minutes prior to anaesthesia induction. Intraoperative Hypotension: 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 - Fluid requirements - Crystalloids - Intraoperatively
timeFrame: 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 - Fluid requirements - Crystalloids - 24 hours postoperatively
timeFrame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
measure: Haemodynamic Stability - Fluid requirements - Colloids - Intraoperatively
timeFrame: 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 - Fluid requirements - Colloids - 24 hours postoperatively
timeFrame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
measure: Haemodynamic Stability - Fluid requirements - Concentrated RBCs - Intraoperatively
timeFrame: 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 - Fluid requirements - Concentrated RBCs - 24 hours postoperatively
timeFrame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
measure: Haemodynamic Stability - Fluid requirements - Plasma - Intraoperatively
timeFrame: 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 - Fluid requirements - Plasma - 24 hours postoperatively
timeFrame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
measure: Haemodynamic Stability - Fluid requirements - Platelets - Intraoperatively
timeFrame: 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 - Fluid requirements - Platelets - 24 hours postoperatively
timeFrame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
measure: Haemodynamic Stability - Blood Loss - Intraoperatively
timeFrame: 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 - Blood Loss - 24 hours postoperatively
timeFrame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
measure: Haemodynamic Stability - Fluid Balance - Intraoperatively
timeFrame: 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 - Fluid Balance - 24 hours postoperatively
timeFrame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
measure: Haemodynamic Stability - Vasoactive Requirements - Adrenaline - Intraoperatively
timeFrame: 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 - Vasoactive Requirements - Adrenaline - 24 hours postoperatively
timeFrame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
measure: Haemodynamic Stability - Vasoactive Requirements - Noradrenaline - Intraoperatively
timeFrame: 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 - Vasoactive Requirements - Noradrenaline - 24 hours postoperatively
timeFrame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
measure: Haemodynamic Stability - Vasoactive Requirements - Ephedrine - Intraoperatively
timeFrame: 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 - Vasoactive Requirements - Ephedrine - 24 hours postoperatively
timeFrame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
measure: Haemodynamic Stability - Vasoactive Requirements - Phenylephrine - Intraoperatively
timeFrame: 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 - Vasoactive Requirements - Phenylephrine - 24 hours postoperatively
timeFrame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
measure: Haemodynamic Stability - Vasoactive Requirements - Dobutamine - Intraoperatively
timeFrame: 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 - Vasoactive Requirements - Dobutamine - 24 hours postoperatively
timeFrame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
measure: Haemodynamic Stability - Vasoactive Requirements - Dopamine - Intraoperatively
timeFrame: 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 - Vasoactive Requirements - Dopamine - 24 hours postoperatively
timeFrame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
measure: Haemodynamic Stability - Vasoactive Requirements - Nitroglycerine - Intraoperatively
timeFrame: 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 - Vasoactive Requirements - Nitroglycerine - 24 hours postoperatively
timeFrame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
Secondary outcomes:
measure: Postoperative pain - Numerical Rating Scale (NRS) - Immediately Postoperatively
timeFrame: 1) Immediately postoperatively (if awakened prior to ICU admission)
measure: Postoperative pain - Numerical Rating Scale (NRS) - First postoperative day
timeFrame: 2) First postoperative day
measure: Postoperative pain - Numerical Rating Scale (NRS) - Second postoperative day
timeFrame: 3) Second postoperative day
measure: Postoperative pain - Numerical Rating Scale (NRS) - Third postoperative day
timeFrame: 4) Third postoperative day
measure: Postoperative pain - Critical Care Pain Observation Tool (CPOT) - Immediately Postoperatively
timeFrame: 1) Immediately postoperatively (if awakened prior to ICU admission)
measure: Postoperative pain - Critical Care Pain Observation Tool (CPOT) - First postoperative day
timeFrame: 2) First postoperative day
measure: Postoperative pain - Critical Care Pain Observation Tool (CPOT) - Second postoperative day
timeFrame: 3) Second postoperative day
measure: Postoperative pain - Critical Care Pain Observation Tool (CPOT) - Third postoperative day
timeFrame: 4) Third postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - First postoperative day
timeFrame: 1) First postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - Second postoperative day
timeFrame: 2) Second postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - Third postoperative day
timeFrame: 3) Third postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - First postoperative day
timeFrame: 1) First postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - Second postoperative day
timeFrame: 2) Second postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - Third postoperative day
timeFrame: 3) Third postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - First postoperative day
timeFrame: 1) First postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - Second postoperative day
timeFrame: 2) Second postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - Third postoperative day
timeFrame: 3) Third postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - First postoperative day
timeFrame: 1) First postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - Second postoperative day
timeFrame: 2) Second postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - Third postoperative day
timeFrame: 3) Third postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - First postoperative day
timeFrame: 1) First postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - Second postoperative day
timeFrame: 2) Second postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - Third postoperative day
timeFrame: 3) Third postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - First postoperative day
timeFrame: 1) First postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - Second postoperative day
timeFrame: 2) Second postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - Third postoperative day
timeFrame: 3) Third postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better
timeFrame: 1) First postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - Second postoperative day
timeFrame: 2) Second postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - Third postoperative day
timeFrame: 3) Third postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - First postoperative day
timeFrame: 1) First postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - Second postoperative day
timeFrame: 2) Second postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - Third postoperative day
timeFrame: 3) Third postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - First postoperative day
timeFrame: 1) First postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - Second postoperative day
timeFrame: 2) Second postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - Third postoperative day
timeFrame: 3) Third postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - First postoperative day
timeFrame: 1) First postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - Second postoperative day
timeFrame: 2) Second postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - Third postoperative day
timeFrame: 3) Third postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - First postoperative day
timeFrame: 1) First postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - Second postoperative day
timeFrame: 2) Second postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - Third postoperative day
timeFrame: 3) Third postoperative day
measure: 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: 1) First postoperative day
measure: 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: 2) Second postoperative day
measure: 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: 3) Third postoperative day
measure: 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: 1) First postoperative day
measure: 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: 2) Second postoperative day
measure: 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: 3) Third postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - First postoperative day
timeFrame: 1) First postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - Second postoperative day
timeFrame: 2) Second postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - Third postoperative day
timeFrame: 3) Third postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - First postoperative day
timeFrame: 1) First postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - Second postoperative day
timeFrame: 2) Second postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - Third postoperative day
timeFrame: 3) Third postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - First postoperative day
timeFrame: 1) First postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - Second postoperative day
timeFrame: 2) Second postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - Third postoperative day
timeFrame: 3) Third postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - First postoperative day
timeFrame: 1) First postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - Second postoperative day
timeFrame: 2) Second postoperative day
measure: Postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - Third postoperative day
timeFrame: 3) Third postoperative day
measure: Analgesic Requirements - First postoperative day
timeFrame: 1) First postoperative day
measure: Analgesic Requirements - Second postoperative day
timeFrame: 2) Second postoperative day
measure: Analgesic Requirements - Third postoperative day
timeFrame: 3) Third postoperative day
measure: Kidney function - Furosemide requirement - Intraoperatively
timeFrame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
measure: Kidney function - Furosemide requirement - 24 hours postoperatively
timeFrame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
measure: Kidney function - MDRD GFR - Preoperatively
timeFrame: 1) Preoperatively (as a baseline)
measure: Kidney function - MDRD GFR - Immediately postoperatively
timeFrame: 2) At the end of surgery 1h after the end of placement of last suture/surgical clip on patient, upon ICU admission.
measure: Kidney function - MDRD GFR - 24h Postoperatively
timeFrame: 3) 24h postoperatively
measure: Kidney function - Urine Output - Intraoperatively
timeFrame: From anesthesia induction, until the end of surgery (end of placement of last suture/surgical clip on patient), assessed up to 8 hours
measure: Kidney function - Urine Output - 24 hours postoperatively
timeFrame: From the end of surgery (end of placement of last suture/surgical clip on patient) until 24 hours postoperatively
measure: Length of stay - ICU
timeFrame: From day of surgery until day of ICU stay.
measure: Length of stay - Hospital Discharge
timeFrame: From day of surgery until hospital discharge
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
References:
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