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.: PACTR202003822626676 Date of Approval: 17/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title erector spinae block in On pump coronary bypass graft surgery
Official scientific title The effect of ultrasound-guided bilateral single shot erector spinae block on recovery after on-pump coronary bypass graft surgery
Brief summary describing the background and objectives of the trial Fast-track anesthesia (FTA) is a procedure that enables extubation in intensive care unit (ICU) within 6 h after surgery to facilitate the recovery of consciousness and autonomous breathing. It has been safely applied to cardiac surgery since the 1990s. FTA is feasible and safe and reduces the occurrence of ventilator induced complications, thereby decreasing ICU stay, resource use and cost. Ultra-fast tract anesthesia (UFTA) was developed after fast-track anesthesia to further optimize the use of medical resource. With UFTA, extubation is performed immediately or within 1 h after surgery in the operating room. The benefits of UFTA include lower incidence of postoperative complications, better hemodynamic performance, shorter ICU stay. Fast track and ultrafast track cardiac anaesthesia can be achieved by reduced opioid doses or opioid free with multimodal analgesia augmented with bilateral regional anaesthesia as erector spinae block (ESP). An ESP block is performed by depositing local anesthetic deep to the erector spinae muscles and superficial to the transverse processes. The block is typically completed under ultrasound guidance and can be performed in cervical, thoracic, or lumbar levels for a wide variety of surgical or chronic pain indications, including cardiothoracic surgery.
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 Treatment: Other
Anticipated trial start date 14/03/2020
Actual trial start date
Anticipated date of last follow up 14/03/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 54
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group erector spinae group patients of this group will receive real bilateral ultrasounded guided single shot erector spinae block at T4 by bupivacaine (20 ml 0.25%) for each side before induction of anaesthesia in sitting position with local infitration of the site of the block then assessment of success of bilateral block within 30 min then start induction of anaesthesia single time patients of this group will receive real bilateral ultrasounded guided single shot erector spinae block at T4 by bupivacaine (20 ml 0.25%) for each side before induction of anaesthesia in sitting position with local infitration of the site of the block then assessment of success of bilateral block within 30 min then start induction of anaesthesia 27
Control Group sham patients of this group patients of this group will receive sham bilateral ultrasounded guided single shot erector spinae block at T4 for each side before induction of anaesthesia in sitting position with local infitration of the site of the block then assessment of success of bilateral block within 30 min then start induction of anaesthesia single time patients of this group patients of this group will receive sham bilateral ultrasounded guided single shot erector spinae block at T4 for each side before induction of anaesthesia in sitting position with local infitration of the site of the block then assessment of success of bilateral block within 30 min then start induction of anaesthesia 27 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patient aged more than 40 years old scheduled for elective open heart surgery including CABG with on pump cardiopulmonary bypass. 1. Patients with severe pulmonary hypertension and / or heart failure. 2. Emergency or combined cardiac surgery. 3. Patients with preoperative use of intra-aortic balloon pump. 4. Patients with poor ventricular function less than 45 %. 5. Patients with preoperative uncontrolled arrhythmia. 6. Patients with moderate to severe hepatic and / or renal dysfunction. 7. Patients with anticipated difficult airway. 8. Severe obstructive and / or restrictive pulmonary function test. Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 75 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 24/02/2020 research ethical commiitte
Ethics Committee Address
Street address City Postal code Country
El Bahr St. Tanta Qism 2, Tanta, Gharbia Governorate, Egypt tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome extubation time duration of mechanical ventilation from the end of anaesthesia till fulfillment weaning criteria and extubated
Secondary Outcome postoperative pain measurement postoperative period
Secondary Outcome the incidence pf re-intubation postoperative period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta university hospitals 1, algeish st, tanta, algharbia governate, egypt tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
tarek abdel hay abdel latif mostafa el guindy st. from omar ibn abdel aziz st., Tanta Qism 2, Tanta, Gharbia Governorate, Egypt tanta 31111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor tanta university 1, algeish st, tanta, algharbia governate, egypt tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
tarek abdel hay abdel latif mostafa el guindy st. from omar ibn abdel aziz st., Tanta Qism 2, Tanta, Gharbia Governorate, Egypt tanta 31111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator tarek mostafa dr.tarek311@yahoo.com 0201003591332 1, algeish st, tanta, algharbia governate, egypt
City Postal code Country Position/Affiliation
tanta 31527 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries bsant kasem bsantsafwat16120167@gmail.com 0201095750853 1, algeish st, tanta, algharbia governate, egypt
City Postal code Country Position/Affiliation
tanta 31527 Egypt assistant lecturer
Role Name Email Phone Street address
Scientific Enquiries sohair soliman sohairsoliman@hotmail.com 0201283929049 El Bahr St.Tanta Qism 2, Tanta, Gharbia Governorate, Egypt
City Postal code Country Position/Affiliation
tanta 31527 Egypt professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes non identified patients data will be available with the principle investigator for 6 months after publication of the paper Study Protocol 6 months from publication of the paper dr.tarek311@yahoo.com
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information