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.: PACTR202008836682092 Date of Approval: 14/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Perioperative analgesic effect of erector spinae plane block versus paravertebral block for breast surgery
Official scientific title Evaluation of erector spinae plane block versus paravertebral block in analgesic outcomes following breast surgery: A randomized controlled study
Brief summary describing the background and objectives of the trial Postoperative analgesia in breast surgery is difficult due to the extensive nature of the surgery and the complex innervation of the breast. Regional anesthesia techniques offer good pain relief, reduce perioperative opioid and anesthetic use, reduces postoperative nausea/vomiting, helps in reducing chronic pain, and facilitates early rehabilitation. Paravertebral block has been proved to be one of the most effective regional anesthesia techniques for effective postoperative analgesia. However, this is also a particularly challenging technique, because of the anatomic proximity of the pleura and central neuraxial system. The erector spinae plane (ESP) block is a newly defined regional anesthesia technique for thoracic analgesia. Its use for other indications, such as abdominal and thoracic surgery, has also recently been reported. In this technique, the local anesthetic injection is performed beneath the erector spinae muscle. The purpose of this randomized, controlled prospective study was to evaluate the analgesic effect of US-guided ESP block in patients undergoing elective breast surgery in comparison to the well-established paravertebral block. The objectives from this randomized, controlled prospective study are to evaluate the perioperative analgesic effect of US-guided ESP block in patients undergoing elective breast surgery in comparison to the well-established paravertebral block, as well as the effect on perioperative hemodynamics , analgesic, and anesthetic drug consumption.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/09/2020
Actual trial start date
Anticipated date of last follow up 01/03/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group erector spinae plane block group 30 ml of 0.25% bupivacaine once after induction of anesthesia after fasting , premedications, and preoxygenation, Induction of anesthesia will be performed by fentanyl 1 mcg/kg, Propofol 2 mg/kg followed by cis-atracurium 0.15 mg/kg. Then, patients will be manually ventilated with 100% oxygen till intubation after 3 min and with a BIS value of 50 % by Macintosh laryngoscope and appropriate size endotracheal tube. Maintenance of anesthesia will be carried out by Isoflurane varying its end-tidal concentration to keep BIS in the range of 50 and cis-atracurium 0.03 mg/kg guided neuromuscular monitor.US-guided ESPB technique: With the patient in a lateral position, A linear array high-frequency US probe will be placed in craniocaudal orientation in the midline at T4 vertebra. The probe will be then moved laterally to identify T4 transverse process (TP). ESM, rhomboid major, and trapezius muscle will be identified, 10 cm block needle will be introduced in-plane craniocaudally under vision, and navigated till the TP was encountered. Hydro dissection with 2 ml normal saline will be done to confirm the separation of ESM from TP. Under US guidance, 30 ml 0.25% bupivacaine will be injected and drug spread will be seen in the ESP plane craniocaudally in real-time. Any increase of MAP or HR more than 25% of baseline measures on two consecutive readings within 2–3 min will be managed by fentanyl 0.5 mcg/kg. Upon completion of wound closure, isoflurane will be discontinued and the residual neuromuscular block will be reversed with neostigmine, 0.05 mg/kg IV, and atropine 0.25 mg/kg, IV. After emergence from anesthesia and immediately in the post-anesthesia care unit, an analgesic regimen, consisting of intravenous patient-controlled morphine analgesia (bolus 1mg, 10-min lockout, maximum dose 5 mg / h) and ketorolac 30mg iv every 12 hrs for 24 hours will be given. 30
Experimental Group paravertebral block group 30 ml of 0.25% bupivacaine once, after induction of anesthesia after fasting, premedications, and preoxygenation, Induction of anesthesia will be performed by fentanyl 1 mcg/kg, Propofol 2 mg/kg followed by cis-atracurium 0.15 mg/kg. Then, patients will be manually ventilated with 100% oxygen till intubation after 3 min and with a BIS value of 50 % by Macintosh laryngoscope and appropriate size endotracheal tube. Maintenance of anesthesia will be carried out by Isoflurane varying its end-tidal concentration to keep BIS in the range of 50 and cis-atracurium 0.03 mg/kg guided neuromuscular monitor.US-guided PVB technique: The patients were placed in a lateral position, resting arms on a table with head and neck flexed and shoulders relaxed. Lidocaine (1%) was used to anesthetize the skin over the entry site. with the guidance of Bedside ultrasound,30 ml of 0.25% bupivacaine will be injected using a10 cm block needle in the PVS at the level of T4 vertebra after confirming proper placement of the needle, and negative aspiration for blood, air, or spinal fluid. Any increase of MAP or HR more than 25% of baseline measures on two consecutive readings within 2–3 min will be managed by fentanyl 0.5 mcg/kg. Upon completion of wound closure, isoflurane will be discontinued and the residual neuromuscular block will be reversed with neostigmine, 0.05 mg/kg IV, and atropine 0.25 mg/kg, IV. After emergence from anesthesia and immediately in the post-anesthesia care unit, an analgesic regimen, consisting of intravenous patient-controlled morphine analgesia (bolus 1mg, 10-min lockout, maximum dose 5 mg / h) and ketorolac 30mg iv every 12 hrs for 24 hours will be given. 30
Control Group Control group 30 ml of normal saline once after induction of anesthesia after fasting, premedications, and preoxygenation, Induction of anesthesia will be performed by fentanyl 1 mcg/kg, Propofol 2 mg/kg followed by cis-atracurium 0.15 mg/kg5. Then, patients will be manually ventilated with 100% oxygen till intubation after 3 min and with a BIS value of 50 % by Macintosh laryngoscope and appropriate size endotracheal tube. Maintenance of anesthesia will be carried out by Isoflurane varying its end-tidal concentration to keep BIS in the range of 50 and cis-atracurium 0.03 mg/kg guided neuromuscular monitor. the patient will be turned lateral, and 30 ml of normal saline will be injected under ultrasound guidance in either the PVS or ESP. Any increase of MAP or HR more than 25% of baseline measures on two consecutive readings within 2–3 min will be managed by fentanyl 0.5 mcg/kg. Upon completion of wound closure, isoflurane will be discontinued and the residual neuromuscular block will be reversed with neostigmine and atropine . After emergence from anesthesia and immediately in the post-anesthesia care unit, an analgesic regimen, consisting of intravenous patient-controlled morphine analgesia (bolus 1mg, 10-min lockout, maximum dose 5 mg / h) and ketorolac 30mg iv every 12 hrs for 24 hours will be given. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Patient aged 20-60 years. -Patients are ASA I or ASA II . -Patients scheduled for modified radical mastectomy. -Patient refusal to participate in the study -Known allergy to local anesthetics. -Body mass index (BMI) more than 35 kg/m2 -Heart block greater than first degree -Renal, and hepatic dysfunction -Underlying coagulopathies Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 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 13/07/2020 Research Ethics Committee Faculty of Medicine Suez Canal University
Ethics Committee Address
Street address City Postal code Country
the ring road,kilo 4.5 ,Ismailia,Egypt ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome total postoperative morphine consumption at the end of 24 h during the first 24 hours after surgery
Secondary Outcome Intraoperative analgesic consumption during surgery
Secondary Outcome Intraoperative hemodynamic response to surgical stimulation, heart rate and blood pressure every 5 mins for the first 30 mins post-induction, then every 15 minutes till the end of surgery
Secondary Outcome intraoperative isoflurane consumption during surgery
Secondary Outcome Postoperative heart rate, blood pressure, and respiratory rate postoperative at 1, 4, 8, 12 and 24 hours.
Secondary Outcome postoperative pain VAS scores postoperative at 1, 4, 8, 12 and 24 hours.
Secondary Outcome postoperative 1st request of analgesia. after finishing surgery
Secondary Outcome Postoperative adverse events: PONV, regional block related hematoma formation, pneumothorax during the first 24 hours after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Suez Canal University Hospital ring road ,kilo 4.5 Ismailia 41522 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Suez Canal University Hospital the ring road,Kilo 4.5 Ismailia 41522 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor anaesthesia departement faculty of medicine suez canal university the ring road ,kilo 4.5 ismailia 41522 Egypt University
Secondary Sponsor suez canal university hospital the ring road ,kilo 4.5 ismailia 41522 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ahmed Mohammed AbdElrahman Elewa ard elgameiat ,elshikh zayed ismailia 41522 Egypt
mohamed elsayed ibrahim ard elgameiat ,elshikh zayed ismailia 41522 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ahmed eliwa ahmedabdelrahman29@gmail.com +201002744572 ard elgameiat,elsheikh zated
City Postal code Country Position/Affiliation
ismailia 41522 Egypt lecturer of anesthesia
Role Name Email Phone Street address
Scientific Enquiries mohamed abdelhamid Mohamed_abuelnga@med.suez.edu.eg +201004150671 ard elgameiat,elsheikh zated
City Postal code Country Position/Affiliation
ismailia 41522 Egypt lecturer of anesthesia
Role Name Email Phone Street address
Public Enquiries mohamed abdelhamid Mohamed_abuelnga@med.suez.edu.eg +201004150671 ard elgameiat,elsheikh zated
City Postal code Country Position/Affiliation
ismailia 41522 Egypt lecturer of anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data after deidentification,study results Informed Consent Form,Study Protocol immediately following publication and upon your request 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