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.: PACTR202201689320554 Date of Approval: 12/01/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title combined transversus thoracic muscle plane block and serratus anterior plane block for breast cancer surgery
Official scientific title Analgesic efficacy of combined transversus thoracic muscle plane block and serratus anterior plane block versus paravertebral block for breast cancer surgery: A non-inferiority trial
Brief summary describing the background and objectives of the trial Breast cancer is common cancer, and the number of breast cancer operations is increasing. Surgery of breast cancer may be associated with significant acute postoperative pain which is an independent risk factor in the development of chronic post-mastectomy pain. Various regional anesthetic procedures have been tried to provide better acute pain control and, consequently, less chronic pain. They can reduce perioperative opiates requirement and thereby decrease their possible side effects. Ultrasound-guided serratus anterior plane block (SAPB) provides analgesia over the anterolateral chest wall by blocking the lateral cutaneous branches of the intercostal nerves. Given its safety and ease of performance, SAPB has been increasingly used for analgesia in patients undergoing mastectomy. The ultrasound-guided transversus thoracic muscle plane (TTP) block can block multiple anterior branches of the intercostal nerves (Th2–6), which dominate the internal mammary region providing analgesia of the anteromedial chest wall. Therefore, a combination of the SAPB and the TTP block may be effective for perioperative analgesia in breast cancer surgery. The aim of this study was to evaluate the analgesic efficacy of the combination of SAPB block and TTP block for breast cancer surgery, compared with the paravertebral block which is the most widely used analgesic regional technique for this type of surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cancer,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 30/12/2021
Actual trial start date
Anticipated date of last follow up 29/09/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status 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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Combined SAPB and TTP block 25 ml of 0.25% bupivacaine for SAPB and 15 mL of 0.25% bupivacaine for TTP block The blocks will be performed as single injections after induction of general anesthesia The technique of U/S guided SAPB : The linear probe will be placed at the level of the fourth or fifth rib along the midaxillary line in the lateral decubitus position. After identifying the latissimus dorsi muscle, serratus anterior muscle, ribs, and pleura, the nerve block needle will be advanced into the plane between the serratus anterior muscle and the corresponding sur­face of the rib using an in-plane technique. Once the correct needle tip position be confirmed, 25 ml of 0.25% bupivacaine will be injected into the target interfascial plane. The technique of U/S guided TTP block : The TTP block will be performed in a supine position. First, a high linear probe of the ultrasound system will be attached at a sagittal plane to the sternum and counted from T2 near the clavicle to T5. Then the linear probe will be rotated by 90°and attached between the fourth and the fifth costal cartilages connecting at the sternum near the nipple. Then, the transversus thoracic muscle and the internal intercostal muscle will be identified. A total of 15 mL of 0.25% bupivacaine will be injected into the interfascial plane, between the transversus thoracic muscle and the internal intercostal muscle between the fourth and fifth costal cartilages connecting at the sternum. Pleural downward displacement could be used as an ultrasound endpoint. After the injection, the spread of local anesthetic was confirmed by using the probe 30
Control Group Paravertebral block Bupivacaine 0.25%, 25 ml will be deposited in the space between the pleura and the costotransverse ligament The block will be performed as a single injection after induction of general anesthesia The TPVB will be administered at the T3 level with the patient in the lateral position. The ultrasound probe will be placed 5 cm from the midline in the craniocaudal direction and moved medially to identify the transverse process and parietal pleura. The superior costotransverse ligament will be identified as a collection of homogeneous linear echogenic bands alternating with echo-poor areas running from one transverse process to the next. Bupivacaine 0.25%, 25 ml will be deposited in the space between the pleura and the costotransverse ligament. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Female patients - Aged between 18 and 60 years old - American Society of Anesthesiologists (ASA) physical status scores of I and II - Undergoing elective unilateral breast surgery - Patient refusal to participate in the study. - Allergy to any medications used in the study. - Uncontrolled hypertension or diabetes. - Neuromuscular disorders such as myopathies and myasthenia gravies. - Patients with coagulopathy psychiatric disorders. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Female
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 06/11/2021 Mansoura Faculty of Medicine Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
2 El Gohorria street Mansoura 35546 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The total dose of morphine consumption During the 1st postoperative 24 h
Secondary Outcome Time of the first analgesic request (duration of the pain-free periods after surgery During the1st postoperative 24 hours
Secondary Outcome Visual analogue score At 0, 1, 4, 8, 12 and 24 hours post-operatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university hospital 2 El-Gomhouria Street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Mahmoud Alseoudy 2 El-Gomhouria Street Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university hospital 2 El-Gomhouria Street Mansoura 35516 Egypt Hospital
Secondary Sponsor Tamer Farahat 2 El-Gomhouria Street Mansoura 35516 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Mahmoud Alseoudy 2 El-Gomhouria Street Mansoura 35516 Egypt
Tamer Farahat 2 El-Gomhouria Street Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Alseoudy drs3ody.mansra@mans.edu.eg +20100622451 2 El- Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of anesthesia and surgical Intensive care at faculty of medicine Mansoura university
Role Name Email Phone Street address
Public Enquiries Tamer Elmetwally tamerfarahat2@yahoo.com +2001005468680 2 El- Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Assistant professor of anesthesia and surgical Intensive care at faculty of medicine Mansoura university
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Alseoudy drs3ody.mansora@mans.edu.eg +201006224551 2 El- Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of anesthesia and surgical Intensive care at faculty of medicine Mansoura university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data that will be shared is the individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Informed Consent Form Within 12 months of the study completion date We will provide individual participant data and share it through the PubMed indexed journal
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