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.: PACTR202110766260656 Date of Approval: 04/10/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Erector Spinae block Vs Thoracic Epidural for Breast surgeries
Official scientific title Comparison between Erector Spinae Plane Block and Thoracic Epidural in Breast Cancer Surgeries under General Anesthesia
Brief summary describing the background and objectives of the trial Breast cancer surgeries are associated with moderate to severe postoperative pain. Thoracic epidural analgesia is a well settled technique for perioperative pain control in breast cancer surgeries. Ultra-sound guided peripheral nerve block is also an ideal option for intraoperative and postoperative analge-sia. Erector spinae plane block is a relatively new analgesic technique introduced in truncal pain man-agement that is still under research. In this study our aim is to compare between the analgesic effects of ultrasound-guided erector spinae plane (ESP) block versus thoracic epidural in breast cancer surgeries, without axillary clearance, done under general anesthesia.
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 Prevention
Anticipated trial start date 09/10/2020
Actual trial start date 09/10/2020
Anticipated date of last follow up 09/11/2020
Actual Last follow-up date 09/11/2020
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
FMASU MS 521 2019 Research ethical committee, Faculty of medicine, Ain Shams University
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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group TE group A 10 ml of bupivacaine 0.25 % will be injected once. after induction of general anesthesia and before the start of surgery Thoracic epidural technique will be performed, the patient will be positioned in the lateral position; skin preparation will be performed using 10% povidone iodine. An 18-gauge Tuohy needle will be inserted in the posterior midline at the level of T4-5, or one space close to this space considering being an easier access; the thoracic epidural space will be identified by means of a loss-of-resistance to injection of saline. 15 Active-Treatment of Control Group
Experimental Group ESP group 20 ml of 0.25% bupivacaine After induction of anesthesia and before start of surgery The erector spinae plane block will be performed, the patient will be positioned for performing the block in the lateral position with the side to be blocked upwards; Skin preparation will be performed using 10% povidone iodine. The block will be performed using ultrasound guided large bandwidth, multi-frequency convex probe (1–8 MHz), the probe will be covered with a sterile cover. A 22G, 100-mm, insulated facet type needle will be used. The block will be performed at the T4 level of the spine using an in-plane approach. A convex probe will be placed 2–3 cm laterally to the spine using a sagittal approach. Once the erector spinae muscle and the transverse processes are identified, the needle will be inserted deep into the mus-cle just superficial to T4 transverse vertebral process. The needle will be directed from a cranial to caudal direction. Following confirmation of the correct position of the needle tip with administration of (0.5–1) ml of local anesthetic (LA), 20 ml of 0.25% bupivacaine will be administered for block performance. LA distribution should be observed in both cranial and caudal directions. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients who are scheduled for elective unilateral breast cancer surgery without axillary clearance. Patients of ASA I or ASA II physical status. Age range between 18-65 years. Body mass index < 35 kg .m-2. Patient’s refusal. Pregnancy or lactation. Significant psychiatric or mental disorders. Known allergic reactions to local anesthetics. Baseline neuropathy or neurological deficits. Patients with infection at the block site. Patients with coagulopathy. Patient on oral narcotics with last dose within 24 hour preoperatively. Herpes zoster infection active form. Patient with kyphoscoliosis. Patients with platelet count less than 100,000/mm3 or on antiplatelet therapy 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 22/12/2019 Research Ethics Committee REC
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine, Ain Shams University, Ramsis st., Abbasia, Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Total opioid consumption in the first 24 hrs postoperatively
Secondary Outcome Pain score using VAS in the post-anaesthesia care unit and at 2 hrs, 4 hrs, 8 hrs, 12 hrs and 24 hrs postoperatively
Secondary Outcome measurement of hemodynamic changes in the post-anaesthesia care unit and at 2 hrs, 4 hrs, 8 hrs, 12 hrs and 24 hrs postoperatively,
Secondary Outcome any complications related to the technique or drugs in the first 24 hrs postoperatively.
Secondary Outcome patient’s satisfaction (0= dis-satisfied, 1=satisfied). in the first 24 hrs postoperatively.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine Ain Shams University Ramsis Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Raafat Abdelazim Hammad Ramsis, Abbasia Cairo Egypt
Mohamed Ramadan Seliem Eissa Ramsis, Abbasia Cairo Egypt
Sherif Sayed Sultan Ramsis, Abbasia Cairo Egypt
Neveen Gerges Fahmy Ramsis, Abbasia Cairo Egypt
Mohamed Ali Sayed Ramsis, Abbasia Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Ain shams university Ramsis st. Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Raafat Abdelazim Hammad Ramsis, Abbasia Cairo Egypt
Mohamed Ramadan Seliem Eissa Ramsis, Abbasia Cairo Egypt
Neveen Gerges Fahmy Ramsis, Abbasia Cairo Egypt
Mohamed Ali Sayed Ramsis, Abbasia Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sherif Sultan sherif_sultan@yahoo.com 00201128448448 Nasr City
City Postal code Country Position/Affiliation
Cairo Egypt Professor at department of Anesthesia Intensive Care and Pain Management Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Public Enquiries Sherif Sultan sherif_sultan@yahoo.com 00201128448448 Nasr City
City Postal code Country Position/Affiliation
Cairo Egypt Professor at department of Anesthesia Intensive Care and Pain Management Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Sherif Sultan sherif_sultan@yahoo.com 00201128448448 Nasr City
City Postal code Country Position/Affiliation
Cairo Egypt Professor at department of Anesthesia Intensive Care and Pain Management Faculty of Medicine Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Study Protocol Beginning 9 months and ending 36 months following article publication internet search by keywords
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