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.: PACTR202309543331995 Date of Approval: 18/09/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison between erector spinae plane block versus serratus anterior plane block regarding analgesia and stress response after modified radical mastectomy.
Official scientific title Comparison between erector spinae plane block versus serratus anterior plane block regarding analgesia and stress response after modified radical mastectomy.
Brief summary describing the background and objectives of the trial Patients who have had breast surgery reported severe acute pain postoperatively. The majority of this pain is brought on by the surgery's axillary component. Poor postoperative pain management has significant effects on the body's physiology as well as its psychological health. Effective acute pain management reduces the need for opioids and general anaesthetics, which prevent the surgical stress response and preserve the immunological response. This led to the impelmentation of multiple plane blocks for better pain control. erector spine plane block and serratus anterior plane block use in breast surgeries have grown due to their relative ease, decreased complications and being away from surgical field compared to other techniques Aim of the Study is to compare between erector spinae plane block (ESP) and serratus anterior plane block (SAP) in patients undergoing modified radical mastectomy regarding pain control and stress response to the surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 24/10/2021
Actual trial start date 24/10/2021
Anticipated date of last follow up 23/10/2022
Actual Last follow-up date 23/10/2022
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
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 24 hours The block was performed with full aseptic precautions after induction of anesthesia and before skin incision by 15 min. Block was conducted at level of T5 in lateral position with arm abducted. Ultrasound probe was placed on the back in a transverse orientation to identify the tip of the T5 transverse process; these were recognizable as flat, squared-off acoustic shadows with only a very faint image of the pleura visible. If the transducer is too lateral, the ribs will be visualized instead; these were recognizable as rounded acoustic shadows with an intervening hyperechoic pleural line. The tip of the transverse process centered on the ultrasound screen and the probe was then be rotated into a longitudinal orientation to produce a parasagittal view, in which the following layers will be visible superficial to the acoustic shadows of the transverse processes: skin and subcutaneous tissue, trapezius, erector spinae muscle and T5 transverse process. , then echogenic block needle was inserted in- plane to the ultrasound beam in a cranial-to-caudal direction until contact is made with the T5 transverse process. Correct location of the needle tip in the fascial plane deep to erector spinae muscle will be confirmed by injecting 0.5-1 ml normal saline and seeing the fluid lifting the erector spinae muscle off the transverse process without distending the muscle. After aspiration to avoid intravascular injection 30 ml bupivacaine 0.25% was injected and separation was seen. The entirety of the needle was visualized at all times throughout the procedure, and care was taken to avoid any vessels while traversing the soft tissue.6-13-MHz, linear transducer for MINDRAY ultrasound device set for small parts and a depth of 1-4 cm was used for this block. 20
Experimental Group serratus anterior plane block 20 ml of 0.25 bupivicaine 24 hours The block was performed with full aseptic precautions after induction of anesthesia and before skin incision by 15 min the patient was placed in supine position with the arm abducted by a trained anesthetist. Ribs were counted in the mid-axillary line from downward upwards until the 5th ribs the linear probe was placed horizontally then three muscles will be identified: latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscles (deep and inferior). the thoracodorsal artery (slightly posterior) were used as extra guide in the identification of the plane superficial to the serratus muscle. The needle was inserted in-plane with respect to the ultrasound probe from supero-anterior to postero-inferior. 0.5: 1 mL of non-active fluid was injected to confirm correct needle tip position by visualizing spread over serratus anterior muscles, then after aspiration to avoid intra vascular injection a total 20 ml of bupivacaine 0.25% were injected between latissmus dorsi and serratus anterior. The entirety of the needle was visualized at all times throughout the procedure, and care was taken to avoid any vessels while traversing the soft tissue.6-13-MHz, linear transducer for MINDRAY ultrasound device set for small parts and a depth of 1-4 cm was used for this block. 20
Control Group intravenous morphine when pain score by NRS exceeds 3 0.05 mg per kg per dose 24 hours giving intravenous morphine according to numerical pain score more than 3 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Female patients Type of surgery; Modified Radical Mastectomy MRM Physical status: ASA I and ASA II. Age ≥ 35 and ≤ 60 Years in order to standardize doses of anesthetics and decrease age group difference in responses. Body mass index (BMI): ≥ 20 kg/m2 and ≤ 35 kg/m2. Patient refusal Known sensitivity or contraindication to drugs used in the study (local anesthetics, opioids). History of psychological disorders and/or chronic pain syndrome. Contraindication to regional anesthesia e.g. local sepsis, pre-existing peripheral neuropathies, coagulopathy and clinical skin infiltration by the tumor. Severe respiratory e.g. (sever obstructive pulmonary disease (forced expiratory volume /forced vital capacity FEV1/FVC <50% or sever restrictive pulmonary disease (total lung capacity TLC<40%), adult respiratory distress syndrome) or sever cardiac disorders e.g. (heart failure). (Martinez-Pitre, Sabbula and Cascella, 2021) Advanced liver disease (Elevated liver enzymes more than 3 folds of normal range). Advanced kidney disease (Decreased creatinine clearance <40 ml/min). (Stevens et al., 2006) Pregnancy. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 35 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 24/10/2021 research ethical comittee for human and animal research faculty of medicine helwan university
Ethics Committee Address
Street address City Postal code Country
helwan university el sekka el hadid elgharbia helwan cairo 11795 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to compare between the two blocks and control group regarding pain scores by numerical rating scale. 0,2,4,6,12and 24 hours post surgery
Primary Outcome to compare between the two blocks and control group regarding stress response by serum cortisol. before and 1 hour after surgery
Secondary Outcome overall fentanyl consumption during operation intra-operative
Secondary Outcome total morphine consumption in first 24 hour after surgery 24 hours after surgery
Secondary Outcome postoperative nausea and vomiting 24 hours after surgery
Secondary Outcome postoperative respiratory depression 0,2,4,6,12,24 hours after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Helwan university hospital el mogawra el ola next to russian university badr city cairo 11829 Egypt
cairo university hospital elkasr elainy street masr el kadema cairo cairo 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
hesham mohamed sultan 140 narges 5 el tagamo3 el khames el qahera el gedida cairo 11835 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor helwan university el sekka el hadid el gharbia helwan cairo 11795 Egypt University
COLLABORATORS
Name Street address City Postal code Country
maged salah mohamed el maadi cairo egypt cairo 11728 Egypt
moataz salah sheikh zayed city cairo 12588 Egypt
ahmed bedewy damanhour el beheira damanhour 22514 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hesham sultan heshamsultan519@gmail.com +201553895516 140 narges 5 eltagamo el khames cairo
City Postal code Country Position/Affiliation
cairo 11835 Egypt assistant lecturer faculty of medicine helwan university
Role Name Email Phone Street address
Public Enquiries motaaz salah moataz.salah@med.helwan.edu.eg +201002200429 el sheikh zayed 6 october
City Postal code Country Position/Affiliation
cairo 12588 Egypt lecturer of anesthesia faculty of medicine helwan university
Role Name Email Phone Street address
Scientific Enquiries ahmed bedewy a.bedewy79@yahoo.com +201061701515 damanhour el beheira
City Postal code Country Position/Affiliation
damanhour 22514 Egypt lecturer of anesthesia faculty of medicine helwan university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in anesthesia and ICU. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Informed Consent Form,Study Protocol 3 months and for 1 year after publication Qualified researchers conducting their own independent research may request controlled access to the trial IPD; this access will be granted following review and approval of a research proposal and execution of a Data Sharing Agreement (DSA).
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