Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202405467152740 Date of Approval: 13/05/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of ultrasound guided Pecto-Intercostal Fascial Plane Block with Levobupivacaine on extubation time after On Pump Coronary Artery Bypass Grafting surgery
Official scientific title The effect of ultrasound guided Pecto-Intercostal Fascial Plane Block with Levobupivacaine on extubation time after On Pump Coronary Artery Bypass Grafting surgery: A randomized control trial
Brief summary describing the background and objectives of the trial Coronary artery bypass grafting (CABG) is considered the gold standard for coronary revascularization. Preventive measures for postoperative pain are always sought to avoid its adverse consequences, the most critical of which are respiratory complications in the form of atelectasis, hypoxemia and pneumonia. It has been found that the worst pain after cardiac surgery is experienced within the first 4 postoperative days, being moderate at rest but severe with coughing or movement. The sensory innervation of the chest wall is derived from the perforating branches of the intercostal nerves, and it is inevitably disturbed during sternotomy in cardiac surgery, causing the consequences of nerve injury pain. Acute postoperative pain is also a predictive risk for chronic pain, and peripheral and central pain sensitization often follows tissue injury. The risk of chronic post surgical pain (CPSP) was found to be directly proportional to the duration of severe postoperative pain. In addition, patients who require ICU stay for more than 48 hours after cardiac surgery have higher in-hospital mortality, lower long-term survival, and higher risk of hospital readmission for cardiac events. Recently, many enhanced recovery after surgery (ERAS) protocols have been applied in cardiac surgery, and in addition to pain control, they include early extubation approach and seem to have good success in reducing time to extubation, ICU length of stay (LOS), hospital LOS, and thus overall costs. They include using a multimodal analgesia approach to reduce the side effects of using opioids as the sole agent, thus preventing the so-called opioid-related adverse drug events. The most serious of these is respiratory depression. Previous studies investigating the effect of pecto-intercostal fascial plane block on postoperative pain in the cardiac surgery population did not consider the effect on extubation time as their primary outcome and were therefore underpowered to correlate between this type
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 21/10/2021
Actual trial start date 21/10/2021
Anticipated date of last follow up 31/10/2022
Actual Last follow-up date 31/10/2022
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Pecto intercostal fascial plane block Following closure of the sternotomy wound till injection of 30 ml of levobupivacaine was done. Cardiopulmonary bypass (CPB) was conducted according to a standardized institutional protocol. All patients received left internal mammary artery graft to the left anterior descending coronary artery. Patients were randomized only if they were successfully weaned from CPB as evidenced by optimum arterial blood gases (pH = 7.35-7.45, pCO2 = 35-45 mmHg, P/F ratio = 300 or more), optimum electrolytes (serum potassium level = 4.5-5.0), good urine output (0.5-1 ml/kg/hour), minimal inotropic support (adrenaline equal to or less than 50 ng/kg/min), with good cardiac output, contractility, and central venous pressure. After complete closure of the sternotomy wound with the patient in the supine position: 1- the anterior chest wall was sterilized using betadine; 2- using linear ultrasound probe, a few centimeters lateral to the upper half of sternal border (beginning with any side of chest wall right or left being sectioned by the sternotomy wound) identification of rib shadows was approached and in between them, from upwards to downwards; skin, subcutaneous tissue, pectoralis major muscle, intercostal muscles, and pleura; 3- in plane with the probe technique, the block needle was placed in the plane between the pectoralis major muscle and external intercostal muscles in a caudal to cephalad direction; 4- to confirm the place of the needle tip, hydrodissection of the fascial plane with the block solution infiltration was done after aspiration test and after applying color Doppler to identify internal mammary artery branches to avoid intra-arterial injection or injury of internal mammary; 5- then injection of 7.5 ml of the block solution was done and was recurred at the lower half of the same sternal border, and then the same was done on the other sternal border side; 6- local infiltration with 30 mL of 0.25% levobupivacaine in two divided doses (15 ml for each side of the sternal border). 30
Control Group Control group Following closure of the sternotomy wound till injection of 30 ml of saline was done. Cardiopulmonary bypass (CPB) was conducted according to a standardized institutional protocol. All patients received left internal mammary artery graft to the left anterior descending coronary artery. Patients were randomized only if they were successfully weaned from CPB as evidenced by optimum arterial blood gases (pH = 7.35-7.45, pCO2 = 35-45 mmHg, P/F ratio = 300 or more), optimum electrolytes (serum potassium level = 4.5-5.0), good urine output (0.5-1 ml/kg/hour), minimal inotropic support (adrenaline equal to or less than 50 ng/kg/min), with good cardiac output, contractility, and central venous pressure. After complete closure of the sternotomy wound with the patient in the supine position: 1- the anterior chest wall was sterilized using betadine; 2- using linear ultrasound probe, a few centimeters lateral to the upper half of sternal border (beginning with any side of chest wall right or left being sectioned by the sternotomy wound) identification of rib shadows was approached and in between them, from upwards to downwards; skin, subcutaneous tissue, pectoralis major muscle, intercostal muscles, and pleura; 3- in plane with the probe technique, the block needle was placed in the plane between the pectoralis major muscle and external intercostal muscles in a caudal to cephalad direction; 4- to confirm the place of the needle tip, hydro-dissection of the fascial plane with the block solution infiltration was done after aspiration test and after applying color Doppler to identify internal mammary artery branches to avoid intra-arterial injection or injury of internal mammary; 5- then injection of 7.5 ml of the block solution was done and was recurred at the lower half of the same sternal border, and then the same was done on the other sternal border side; 6- local infiltration with 30 mL of normal saline in two divided doses (15 ml for each side of the sternal border). 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients older than 18 year-old Weight of 50 kg or more Candidates for On Pump CABG through median sternotomy Successfully CPB-weaned Patients' refusal Patients undergoing emergency CABG Patients with morbid obesity (body mass index of 40 or more) Patients suffering from systolic dysfunction (ejection fraction less than 50%) Patients having associated valve lesions Patients with chronic obstructive pulmonary disease or moderate to severe asthma (% predicted FEV1: moderate = 69-60, moderate-severe = 59-50, severe = 49-35, very severe < 35) Patients on adrenaline support > 50 ng/kg/min Patients with history of substance abuse 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 85 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/10/2021 Research Ethics Committee Faculty of Medicine Cairo University
Ethics Committee Address
Street address City Postal code Country
Kasr Alainy street Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Extubation time Time since complete closure of the chest wall
Secondary Outcome Visual Analog Scale score At 0, 2, 4, 6, and 12 hours post-extubation
Secondary Outcome Total dose of fentanyl consumption Total fentanyl dose during ICU stay
Secondary Outcome ICU length of stay At the end of ICU stay
Secondary Outcome Hospital length of stay At the end of admission to the cardiothoracic department ward
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Hospitals Kasr A Ainy Street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Marwa Samir Mahmoud Kasr Alainy Street Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Hospitals Kasr Alainy Street Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Marwa Mahmoud marwa.s.mahmoud@email.com +201003505696 Kasr Alainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University
Role Name Email Phone Street address
Public Enquiries Marwa Mahmoud marwa.s.mahmoud@email.com +201003505696 Kasr Alainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University
Role Name Email Phone Street address
Principal Investigator Aiman Dessouki aadessouki@gmail.com +201005767493 Kasr Alainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share the individual de-identified participants’ data. The datasets generated during and/or analyzed during the current study will be available from the corresponding author on reasonable request, beginning 12 months and ending 36 months following article publication. Study Protocol From 12 to 36 months after article publication Data will be accessible on reasonable request through direct contact with the corresponding author, to be used for systematic reviews or meta-analyses.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 15/04/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 15/04/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information