Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06244732
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-01-27
Brief Title:
Pain Control After Aortic EndoaneurYsmEctomy POPEYE
Sponsor:
IRCCS Policlinico S Donato
Organization:
IRCCS Policlinico S Donato
Study Overview
Official Title:
Post-Operative Pain Control After Aortic EndoaneurYsmEctomy
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POPEYE
Brief Summary:
Open abdominal aortic aneurysm repair OR-AAA is an operation associated with high morbidity and has 30-day mortality rates of between 4 and 14 Post-operative pain management represents a primary anesthetic focus
A better analgesia in addition to being desirable for the patient can potentially reduce complications associated with postoperative pain and ensure faster functional recovery
The modern concept of multimodal analgesia involves the association of multiple drugs andor analgesic techniques to maximize the quality of analgesia and reduce the side effects of the individual methods In this context the addition of epidural analgesia EA to the intravenous administration of traditional analgesic drugs has assumed the role of gold standard in many surgeries including OR-AAA
Over time EA has proven to be a better analgesic technique than the use of intravenous opioids alone however there is much uncertainty regarding its ability to reduce complications morbidity and mortality of patients
For some time efforts to research effective less invasive and safe anesthetic alternatives have been directed towards the development of multimodal analgesia protocols with the aim of reducing complications and ensuring faster recovery New approaches to post-operative pain management are emerging including rectus sheat block RSB
Currently there is no evidence regarding the effectiveness of RSB in pain control after OR-AAA
In this context the study aims to compare two different post-operative pain management protocols with the aim of verifying whether the use of RSB can guarantee a non-inferior level of analgesia with reduction of complications compared to AE
A better analgesia in addition to being desirable for the patient can potentially reduce complications associated with postoperative pain and ensure faster functional recovery
The modern concept of multimodal analgesia involves the association of multiple drugs andor analgesic techniques to maximize the quality of analgesia and reduce the side effects of the individual methods In this context the addition of epidural analgesia EA to the intravenous administration of traditional analgesic drugs has assumed the role of gold standard in many surgeries including OR-AAA
Over time EA has proven to be a better analgesic technique than the use of intravenous opioids alone however there is much uncertainty regarding its ability to reduce complications morbidity and mortality of patients
For some time efforts to research effective less invasive and safe anesthetic alternatives have been directed towards the development of multimodal analgesia protocols with the aim of reducing complications and ensuring faster recovery New approaches to post-operative pain management are emerging including rectus sheat block RSB
Currently there is no evidence regarding the effectiveness of RSB in pain control after OR-AAA
In this context the study aims to compare two different post-operative pain management protocols with the aim of verifying whether the use of RSB can guarantee a non-inferior level of analgesia with reduction of complications compared to AE
Detailed Description:
This is a prospective randomized controlled single-centre non-profit spontaneous study which involves the evaluation of the control of post-operative pain in a population of adult patients admitted to the General Intensive Care Unit after elective open endoaneurysmectomy of the abdominal aorta
The study will be conducted by analyzing two groups of patients randomized to receive ether postoperative analgesia via epidural catheter EA Group or repeated blocks of the rectus fascia RSB Group
Pre- and intra-operative management In EA Group the epidural catheter will be positioned according to the normal practices of the Operating Unit before the operation The insertion of the catheter will be carried out at the T10-T12 level for a maximum of 5-7 cm in the epidural space
For both groups under study the operation will be conducted under balanced general anesthesia using a volatile anesthetic Desflurane or Sevoflurane associated with Remifentanil with titratable doses in order to guarantee an adequate depth of anesthesia understood as bispectral index BIS between 40 and 60 Myoresolution will be maintained with the use of neuromuscular monitoring TOF Train Of Four
After intubation the bladder catheter nasogastric tube central venous catheter with ultrasound-guided technique will be positioned and the following will be prepared
Cell saver for blood recovery
Body temperature monitoring via throat probe
Minimally invasive arterial hemodynamic monitoring with FloTrac system and continuous detection of the following parameters
Mean arterial pressure MAP
Cardiac Index CI
Stroke Volume Variation SVV These parameters as usual will guide the anesthetic conduct for the optimization of blood volume and intraoperative hemodynamic performance
Prophylaxis of nausea and vomiting will be carried out by administering Dexamethasone 4 mg to all patients at induction and Ondansetron 4 mg before extubation
Upon closure of the abdominal muscle fascia intravenous analgesia will be administered with Paracetamol 1 g Ibuprofen 600 mg and MgSO4 2 g At the end of the surgical procedure each patient as usual and regardless of the study protocol will be transferred to the General Intensive Care Unit where monitoring and the subsequent recovery phase will continue
Post-operative management All patients will be transferred to the General Intensive Care Unit with continued sedation and mechanical ventilation in order to standardize the close monitoring of vital functions the recovery phase and the management of the analgesia protocol
Each patient will be eligible for awakening and extubation - and therefore for the start of the analgesia protocol - once all the following criteria have been met
Body temperature 355 C
MAP 65 mmHg with max basic norepinephrine dosage 01 mcgkgmin
TOF-Ratio 09 If the conditions for awakening are not respected the clinical conditions will be optimized in order to restore the stability necessary for extubation Patients who have not reached the aforementioned criteria within 12 hours of admission to the ICU will exit the study protocol see drop-out criteria
From the moment of awakening T0 observation and data collection will continue in the Intensive Care Unit for a total of 36 hours
Analgesia protocol
The administration of analgesia according to the usual protocols will begin before awakening in those patients who have met the criteria for extubation
Group EA will receive analgesia via epidural catheter Ropivacaine 015 with double initial bolus and subsequent continuous infusion 5 mlh via elastomeric pump
in the RSB Group repeated blocks of the abdominal wall will be performed using special catheters positioned bilaterally in the rectus muscle fascia using ultrasound guidance Ropivacaine 0375 20 ml per side administered every 12 hours at T0 T12 and T24 In addition both groups will be administered intravenous analgesia at predetermined times 1 g of paracetamol QID quater in day except for patients 50 kg andor with risk factors for hepatotoxicity in which it will be administered in a total dose of 3 gday 600 mg of ibuprofen BID bis in day and 2 g of MgSO4 TID tris in day
Pain symptoms will be assessed according to the NRS scale This system involves the direct evaluation by the patient of the degree of pain perceived on a scale ranging from 0 no pain to 10 worst possible pain In our study we will consider values greater than or equal to 4 to be unacceptable In this case rescue therapy with opioids is envisaged in addition to the intravenous therapy normally administered The opioid of choice for our protocol is intravenous morphine administered in boluses at a dosage of 2 mg repeatable every 15 minutes max 8 mg in one hour until pain symptoms improve with NRS4 or appearance of side effects considering a maximum daily dose of 50 mg
Data collection
The following variables will be collected from the medical records which will then be pseudonymised and inserted into a database to be adequately analysed
1 Pre-operative
1 Anthropometric parameters age sex BMI
2 ASA class
3 Revised Cardiac Risk Index
4 METS
5 Major comorbidities
i Diabetes mellitus DM ii Ischemic heart disease IC iii Heart failure HFS iv Chronic obstructive pulmonary disease COPD v Chronic kidney disease CKD vi Other significant pathologies
2 Intra-operative
a Type of surgical procedure i aortobisiliac repair AO-BIS ii aorto-bifemoral repair AO-BIF iii aorto-aortic AO-AO repair b Surgical time c Time and type of aortic clamping d Hemodynamic parameters and events i Maximum dosage of Norepinephrine mcgkgmin ii MAP 65 mmHg iii FloTrac CI 2 Lmin andor SVV 13 iv Water balance v Total transfusions in ml exogenous blood recovery vi Intraoperative AAII thrombotic complications
3 Post-operative
a Pain NRS scale both at rest static and upon coughing dynamic i upon awakening T0 ii 2 4 8 12 18 24 30 36 hours after waking up b Total dose of rescue opioid c Occurrence of complications related to the operation andor the patients comorbidities i Re-intervention ii Thrombosis AAII iii Hemorrhage iv major cardiac complications ACS ACC arrhythmias v infectious complications wound infection sepsis septic shock vi pulmonary complications pneumonia respiratory failure pulmonary edema vii acute renal failure d Occurrence of complications related to the therapy administered i Nauseavomiting from opioid consumption ii Failure of the analgesic technique uncontrolled pain iii Hypotension treatable with max norepinephrine base 01 mcgkgmin iv Hypotension not treatable without higher doses of basic norepinephrine v Paresthesia of lower limbs vi Motor deficit of lower limbs vii Other complications of AE direct neurological damage dural puncture headache subarachnoid injectionspinal anesthesia urinary retention low back pain epidural hematoma infection drug allergy AL absorption viii Other complications of RSB infections fascial hematoma drug allergy AL absorption The analysis continues for a total period of 36 hours after waking up in the Intensive Care Unit The length of in-hospital stay will be also recorded
The study will be conducted by analyzing two groups of patients randomized to receive ether postoperative analgesia via epidural catheter EA Group or repeated blocks of the rectus fascia RSB Group
Pre- and intra-operative management In EA Group the epidural catheter will be positioned according to the normal practices of the Operating Unit before the operation The insertion of the catheter will be carried out at the T10-T12 level for a maximum of 5-7 cm in the epidural space
For both groups under study the operation will be conducted under balanced general anesthesia using a volatile anesthetic Desflurane or Sevoflurane associated with Remifentanil with titratable doses in order to guarantee an adequate depth of anesthesia understood as bispectral index BIS between 40 and 60 Myoresolution will be maintained with the use of neuromuscular monitoring TOF Train Of Four
After intubation the bladder catheter nasogastric tube central venous catheter with ultrasound-guided technique will be positioned and the following will be prepared
Cell saver for blood recovery
Body temperature monitoring via throat probe
Minimally invasive arterial hemodynamic monitoring with FloTrac system and continuous detection of the following parameters
Mean arterial pressure MAP
Cardiac Index CI
Stroke Volume Variation SVV These parameters as usual will guide the anesthetic conduct for the optimization of blood volume and intraoperative hemodynamic performance
Prophylaxis of nausea and vomiting will be carried out by administering Dexamethasone 4 mg to all patients at induction and Ondansetron 4 mg before extubation
Upon closure of the abdominal muscle fascia intravenous analgesia will be administered with Paracetamol 1 g Ibuprofen 600 mg and MgSO4 2 g At the end of the surgical procedure each patient as usual and regardless of the study protocol will be transferred to the General Intensive Care Unit where monitoring and the subsequent recovery phase will continue
Post-operative management All patients will be transferred to the General Intensive Care Unit with continued sedation and mechanical ventilation in order to standardize the close monitoring of vital functions the recovery phase and the management of the analgesia protocol
Each patient will be eligible for awakening and extubation - and therefore for the start of the analgesia protocol - once all the following criteria have been met
Body temperature 355 C
MAP 65 mmHg with max basic norepinephrine dosage 01 mcgkgmin
TOF-Ratio 09 If the conditions for awakening are not respected the clinical conditions will be optimized in order to restore the stability necessary for extubation Patients who have not reached the aforementioned criteria within 12 hours of admission to the ICU will exit the study protocol see drop-out criteria
From the moment of awakening T0 observation and data collection will continue in the Intensive Care Unit for a total of 36 hours
Analgesia protocol
The administration of analgesia according to the usual protocols will begin before awakening in those patients who have met the criteria for extubation
Group EA will receive analgesia via epidural catheter Ropivacaine 015 with double initial bolus and subsequent continuous infusion 5 mlh via elastomeric pump
in the RSB Group repeated blocks of the abdominal wall will be performed using special catheters positioned bilaterally in the rectus muscle fascia using ultrasound guidance Ropivacaine 0375 20 ml per side administered every 12 hours at T0 T12 and T24 In addition both groups will be administered intravenous analgesia at predetermined times 1 g of paracetamol QID quater in day except for patients 50 kg andor with risk factors for hepatotoxicity in which it will be administered in a total dose of 3 gday 600 mg of ibuprofen BID bis in day and 2 g of MgSO4 TID tris in day
Pain symptoms will be assessed according to the NRS scale This system involves the direct evaluation by the patient of the degree of pain perceived on a scale ranging from 0 no pain to 10 worst possible pain In our study we will consider values greater than or equal to 4 to be unacceptable In this case rescue therapy with opioids is envisaged in addition to the intravenous therapy normally administered The opioid of choice for our protocol is intravenous morphine administered in boluses at a dosage of 2 mg repeatable every 15 minutes max 8 mg in one hour until pain symptoms improve with NRS4 or appearance of side effects considering a maximum daily dose of 50 mg
Data collection
The following variables will be collected from the medical records which will then be pseudonymised and inserted into a database to be adequately analysed
1 Pre-operative
1 Anthropometric parameters age sex BMI
2 ASA class
3 Revised Cardiac Risk Index
4 METS
5 Major comorbidities
i Diabetes mellitus DM ii Ischemic heart disease IC iii Heart failure HFS iv Chronic obstructive pulmonary disease COPD v Chronic kidney disease CKD vi Other significant pathologies
2 Intra-operative
a Type of surgical procedure i aortobisiliac repair AO-BIS ii aorto-bifemoral repair AO-BIF iii aorto-aortic AO-AO repair b Surgical time c Time and type of aortic clamping d Hemodynamic parameters and events i Maximum dosage of Norepinephrine mcgkgmin ii MAP 65 mmHg iii FloTrac CI 2 Lmin andor SVV 13 iv Water balance v Total transfusions in ml exogenous blood recovery vi Intraoperative AAII thrombotic complications
3 Post-operative
a Pain NRS scale both at rest static and upon coughing dynamic i upon awakening T0 ii 2 4 8 12 18 24 30 36 hours after waking up b Total dose of rescue opioid c Occurrence of complications related to the operation andor the patients comorbidities i Re-intervention ii Thrombosis AAII iii Hemorrhage iv major cardiac complications ACS ACC arrhythmias v infectious complications wound infection sepsis septic shock vi pulmonary complications pneumonia respiratory failure pulmonary edema vii acute renal failure d Occurrence of complications related to the therapy administered i Nauseavomiting from opioid consumption ii Failure of the analgesic technique uncontrolled pain iii Hypotension treatable with max norepinephrine base 01 mcgkgmin iv Hypotension not treatable without higher doses of basic norepinephrine v Paresthesia of lower limbs vi Motor deficit of lower limbs vii Other complications of AE direct neurological damage dural puncture headache subarachnoid injectionspinal anesthesia urinary retention low back pain epidural hematoma infection drug allergy AL absorption viii Other complications of RSB infections fascial hematoma drug allergy AL absorption The analysis continues for a total period of 36 hours after waking up in the Intensive Care Unit The length of in-hospital stay will be also recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None