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.: PACTR202203859764512 Date of Approval: 24/03/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Effect of Combined Ultrasound-Guided Transverse Thoracic Muscle Plane Block and Rectus Sheath Plane Block on the Peri-operative Consumption of Opioids in Open Heart Surgeries with Median Sternotomy
Official scientific title The Effect of Combined Ultrasound-Guided Transverse Thoracic Muscle Plane Block and Rectus Sheath Plane Block on the Peri-operative Consumption of Opioids in Open Heart Surgeries with Median Sternotomy
Brief summary describing the background and objectives of the trial In recent years, the popularity of fascial plane blocks accompanied by ultrasound has increased in achieving an effective postoperative analgesia. Mastering the use of ultrasound encourages anesthetists on the frequent use of regional anesthesia. Fascial plane blocks in which the risk of bleeding is low compared with central neuraxial techniques or deep nerve blocks are increasingly becoming a part of multimodal analgesia as an alternative pain management strategy in cardiac surgery. Data -other than a pilot study- evaluating the effect of the Transverse Thoracic Muscle Plane (TTP) block on sternotomy pain are in the form of case reports. This study aims to spot on the effectiveness of combining TTP and Rectus Sheath Plane (RSP) block in cardiac 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: Drugs
Anticipated trial start date 01/01/2022
Actual trial start date 24/01/2022
Anticipated date of last follow up 05/10/2022
Actual Last follow-up date 05/10/2022
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Transverse Thoracic Muscle Plane Block and Rectus Sheath Block 20 ml of Bupivacaine 0.25% in each site of injection with a total 4 sites of injection Single injections 10-20 minutes just before the skin incision A linear ultrasound probe is placed in the transverse plane 1 cm lateral to the edge of the sternum in the 3rd or 4th intercostal space. The internal intercostal and transverse thoracic muscles, as well as the internal thoracic artery and vein, are identified over the pleura. A 50- mm block needle is placed in the interfacial plane between the transverse thoracic and the inner intercostals muscles using the in-plane technique, and localization is confirmed before injection by a 3-mL saline hydro-dissection (by seeing the downward motion of the pleura). Next, 20 mL of 0.25% bupivacaine is injected bilaterally 25
Control Group General anesthesia without nerve blocks The general anesthesia (GA) is induced by administering 0.3 mg/kg of Midazolam, 3-5 mg/kg of Thiopental sodium, and 0.5 mg/kg of Atracurium. Fentanyl is given as a 3-5 mcg/kg bolus just before the induction Maintanance of GA by inhalational anesthetics with IV infusion of Atracurium (dose: 0.1-0.3 mg/kg/hr) and boluses of opioids (mainly Fentanyl in the form of 50-100 mcg/bolus) A linear ultrasound probe is placed in the transverse plane 1 cm lateral to the edge of the sternum in the 3rd or 4th intercostal space. The internal intercostal and transverse thoracic muscles, as well as the internal thoracic artery and vein, are identified over the pleura. A 50- mm block needle is placed in the interfacial plane between the transverse thoracic and the inner intercostals muscles using the in-plane technique, and localization is confirmed before injection by a 3-mL saline hydro-dissection (by seeing the downward motion of the pleura). In the control group, using saline instead of local anesthetic (Bupivacaine) is done 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients with American Society of Anesthesiologists (ASA) score III – IV. 2. Patients from both sexes. 3. Patients aged ≥ 18 years old. 4. Patients scheduled for certain cardiac surgery with median sternotomy including valve(s) replacement/repair, surgical repair for ascending aorta, closure of congenital Atrial Septal Defect (ASD), and coronary artery bypass grafting (CABG) surgery using a NON Internal Thoracic Arterial graft. 1. Patients refusing to be involved in this study. 2. Patients with ASA score > IV. 3. Patients aged < 18 years. 4. Patients scheduled for an expected CABG surgery using the Internal Thoracic Artery. 5. Patients scheduled for pericardial effusion drainage, surgical debridement or re-wiring the sternal bone. 6. Patients scheduled for urgent cardiac surgery. 7. Patients with local infection at the site of needle puncture. 8. Patients with known hypersensitivity to local anesthetic (LA). 9. Patients with possible development of LA toxicity (i.e. decompensated hepatic patients). 10. Patients hardly to be candidates for Fast Tract Extubation in ICU such as: - Patients on high doses of inotropes and/or vasopressors. - Patients with high drain(s) in the first 6 hours post-operatively. - Patients who needed an intra-aortic balloon pump (IABP) post- CardioPulmonary Bypass (CPB). - Patients who needed a cardiac temporary pacing. - Patients with delayed recovery (≥ 6 hours post-operative) in the ICU due to hypotension, stroke, brain edema, hypothermia, acidosis... etc. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 05/10/2021 Research Ethical Committee at Faculty of Medicine Ain Shams University
Ethics Committee Address
Street address City Postal code Country
38 Abbassia Square, Next to Al-Nour Mosque Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The initial consumption of opioids mainly Fentanyl with the skin incision and sternotomy incision From time of skin incision to the time sternotomy incision
Secondary Outcome The total peri-operative consumption of opioids including intra-operative Fentanyl and Morphine, and post-operative Morphine increments in the post cardiac surgery care unit according to the pain score assessment From the time of skin incision and till 6 hours post-operatively
Secondary Outcome Post-operative pain assessment using the Visual Analogue Scale (VAS). It consists of a 10 cm straight line with the endpoints defining extreme levels of ‘NO pain at all’ (0 cm) and ‘pain as bad as it could be’ (10 cm). A blind observer is asked to mark the pain level he is observing on the patient in the ICU on the line between these two endpoints. The distance between 0 and the mark then denotes the patient’s pain score. Every 60 minutes and for 6 hours since ICU admission
Secondary Outcome Time needed to extubate the patient post-operatively in the post cardiac surgery care unit as an indicator of better lung mechanics due to decreased levels of pain Since transferring the patient from the operating room to the care unit
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine Ain Shams University 38 Abbassia Square, Next to Al-Nour Mosque Cairo 1181 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
The Principle Investigator Hafez Ramdan St., Police Buildings, Building No. 2, Nasr City Cairo 11765 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Ain Shams University 38 Abbassia Square, Next to Al-Nour Mosque Cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Fady Medhat Mokhtar Nessim Hafez Ramdan St., Police Buildings, Building No. 2, Nasr City Cairo 11765 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Fady Nessim fady.medhat@med.asu.edu.eg +201225544236 Hafez Ramdan St., Police Buildings, Building No. 2, Nasr City
City Postal code Country Position/Affiliation
Cairo 11765 Egypt Assistant Lecturer in Department of Anesthesia Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Alaa Hassan dralaa_hassan@med.asu.edu.eg +201222167416 355 Ramses St.
City Postal code Country Position/Affiliation
Cairo Egypt Professor at Anesthesia Department Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Principal Investigator Riham Nady rihamfathy@live.com +201225397227 26A Qassem Amin St., Hadaeq El-Kobba
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer at Anesthesia Department Faculty of Medicine Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual data collected during the trial, after de-identification Study Protocol Following publication Any purpose
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