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.: PACTR202011498725223 Date of Registration: 27/11/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The postoperative analgesic effectiveness of ultrasound-guided Erector spinae plane block versus serratus anterior plane block for modified radical mastectomy: A randomised, controlled trial
Official scientific title The postoperative analgesic effectiveness of ultrasound-guided Erector spinae plane block versus serratus anterior plane block for modified radical mastectomy: A randomised, controlled trial
Brief summary describing the background and objectives of the trial Recently, Forero et al. described ultrasound-guided erector spinae plane (ESP) block as a novel analgesic technique in which local anesthesia injection is done beneath the erector spinae muscle. Previous studies reported effective postoperative pain reduction with ESP block after radical mastectomy surgery. Ultrasound-guided interfascial plane blocks such as pectoral nerve (PECS) block type 1 and 2 and serratus anterior plane block (SPB) have also been reported as alternatives, with the advantages of simplicity and ease of performance. The aim of the study is to compare the postoperative analgesic effectiveness of ultrasound-guided ESP block versus ultrasound-guided SPB in patients undergoing modified radical mastectomy with axillary dissection.
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 30/11/2020
Actual trial start date 01/12/2020
Anticipated date of last follow up 25/02/2021
Actual Last follow-up date 02/03/2021
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL Not available
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 erector spinae plane block 20 mL of 0.25% bupivacaine will be administered between erector spinae muscle and transverse process after negative aspiration of blood, air, or cerebrospinal fluid for block performance and local anesthesia will be distributed cranially and caudally after induction of general anesthesia and the ESP block will be performed unilaterally at site of operation The patients in group (A) will be put in lateral position after induction of general anesthesia and the ESP block will be performed unilaterally after identification of the thoracic T4 and T5 transverse processes and the erector spinae muscle with the probe placed 2–3 cm lateral to the spine with a sagittal approach. A 22-gauge spinal needle will be inserted into the muscle deeply as the transverse processes and the erector spinae muscle will be identified. The needle will be directed craniocaudally, and 20 mL of 0.25% bupivacaine will be administered between erector spinae muscle and transverse process after negative aspiration of blood, air, or cerebrospinal fluid for block performance and local anesthesia will be distributed cranially and caudally 30
Control Group ultrasound guided serratus anterior plane block SPB 20 ml of 0.25% bupivacaine will be injected superficial to the serratus anterior muscle after induction of general anesthesia and the serratus anterior plane block will be performed unilaterally The patients will remain in supine position after induction of general anesthesia and the US-SPB will be done with the ultrasound probe positioned longitudinally oblique just below the mid-clavicle. After identifying the second rib, the probe will be moved caudally and laterally (obliquely), towards the mid-axillary line to identify the 3rd , 4th and 5th ribs. Finally, the probe will be positioned with its cephalad end resting over the anterior axillary line and the caudad end will be over the posterior axillary line. The fascial plane between the serratus anterior muscle and latissimus dorsi muscle will be identified between the 4th and 5 th rib in the mid-axillary region. Under ultrasound guidance, a 22-gauge, spinal needle will be advanced in-plane to enter this fascial plane in the superoanterior to posteroinferior direction. Once the needle was in proper position, 20 ml of 0.25% bupivacaine will be injected superficial to the serratus anterior muscle. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
female patients undergoing unilateral MRM with axillary lymph node dissection aged 18–65 years the American Society of Anesthesiologists (ASA) Physical Status classification, I–II. To ensure standardized operation and anesthetic techniques, we enrolled patients operated on by a single surgeon. patients refusal physical status ASA III or more body mass index (BMI) ≥ 35 kg/m coagulation disorders local infection at the site of injection local anesthetic allergy, history of drug addiction. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 65 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 17/11/2020 Research ethics committee Ain shams university faculty of medicine
Ethics Committee Address
Street address City Postal code Country
Ramsis street, Abbassia Cairo 115911 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative pain intensity assessed by the Visual Analogue Scale (VAS) will be recorded immediately upon arrival to PACU, and after 30 minutes, then at 2, 6, 12, and 24 hrs postoperatively.
Secondary Outcome measuring the time that elapses till rescue analgesia (Nalbuphine 5 mg IV) is firstly requested postoperatively for break through severe pain (VAS ≥ 4) once VAS exceeded score 4
Secondary Outcome Total dose of rescue analgesia given during the first24 hours postoperatively
Secondary Outcome Postopeative hemodynamic parameters ( heart rate and mean arterial pressure) recorded immediately upon arrival to PACU every 15 min for 30 minutes and at 2, 4, 6,12, and 24 hrs.
Secondary Outcome Side effects related to the analgesic technique used during the first 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams faculty of medicine hospitals Ramsis street, Abbassia Cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
tamer nabil Ramsis street, abbassia dairo 11591 Egypt
Sahar Talaat Ramsis street, Abbassia Cairo 11591 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tamer Nabil Sanar Ramses street Cairo Egypt self funded
COLLABORATORS
Name Street address City Postal code Country
sahar talaat 234 Salah Salem Street Cairo 11591 Egypt
tamer Nabil 388 dr mohamed badawy street, 2nd district 6 th October city Giza 11591 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator tamer Abdelrahman tamernabil610@gmail.com +201288992910 faculty of medicine, Ramsis street, Abbassia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt lecturer of anesthesia and intensive care at ain shams universty
Role Name Email Phone Street address
Public Enquiries fathy tash dean@med.asu.du.eg +2026857539 faculty of medicine, Ramsis treet, Abbassia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt head of ethics committee
Role Name Email Phone Street address
Scientific Enquiries Sahar Talaat saharta2000@hotmail.com +2012274630000 Faculty of medicine , Ramsis street, Abbassia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Assistant Professor of anesthesia and intensive care department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes yes available as excel sheets Statistical Analysis Plan Twelve months Editors of the journal to be submitted to
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not available 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