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.: PACTR201910691333405 Date of Approval: 17/10/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Assessment of the efficacy of ultrasound guided erector spinae plane block for postoperative analgesia in thoracolumbar spinal surgeries
Official scientific title Assessment of the efficacy of ultrasound guided erector spinae plane block for postoperative analgesia in thoracolumbar spinal surgeries
Brief summary describing the background and objectives of the trial Pain after spinal surgeries represent great challenge to every anaesthetist. Different multimodal anaesthetics drugs as intravenous lidocaine, ketamine, paracetamol, NSAID and local wound infiltration has been used to decrease the dependency on opioids. Erector spinae plane block is relatively a new block, described in 2016, which can block ventral, dorsal and rami communicates. Erector spinae fascia extends from nuchal fascia to sacrum Primary Objective: Post-operative morphine consumption in postoperative Day 1.
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: Drugs
Anticipated trial start date 01/09/2019
Actual trial start date 06/10/2019
Anticipated date of last follow up 02/02/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 22
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 ESP Single injection of 20 mls of 0.25% Bupvicaine will be injected bilaterally before start of the surgery N/A After standard monitoring, Anaesthesia will be induced with propofol 2-3 mg/kg, fentanyl 2mcg/kg and atracuirium 0.5 mg/kg to facilitate intubation. Patients will be positioned prone. With high frequency linear probe, ESP block will be done on both side with 20 mls of 0.25% bupivacaine at the same surgical level in single level surgery or at the vertebral level in the middle of the surgical field in surgeries involving multiple levels. LA will be injected below the erector spinae muscle. Intraoperative pain will be managed with fentanyl 0.5 mcg/kg bolus and paracetamol 1g. Postoperatively, patients will receive paracetamol 1gm every 6 hours. Any increase in VAS ≥4 will be managed with 1mg morphine IV which will be repeated every 10 minutes untill control of the pain. 11
Control Group Control Nil N/A Anaesthesia will be induced with propofol 2-3 mg/kg, fentanyl 2mcg/kg and atracuirium 0.5 mg/kg to facilitate intubation. Patients will be positioned prone. Intraoperative anlgesia will be managed with fentanyl 0.5 mcg/kg and paracetamol 1 g. Control group will not receive ESP block. Postoperatively, patients will receive paracetamol 1gm every 6 hours. Any increase in VAS ≥4 will be managed with 1mg morphine IV which will be repeated every 10 minutes untill control of the pain. 11 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA 1-3 patients scheduled for lower thoracic or lumbar spinal surgery Age 18-65 years Sex: Both male and female Patient with chronic pain syndrome Patients on long term opioids. History of allergy to local anaesthetics Recurrent back surgeries Chronic Kidney disease Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),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 30/09/2019 Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ring Road Ismailia 51522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Post operative morphine consumption in milligrams for the first 24 hours after surgery, compared to the consumption of the control group to assess if the intervention will reduce the opioid needs in thorasic and lumbar spine surgery.Pain will be assessed using the visual analogue scale. 24 hours
Secondary Outcome Visual Analogue Scale will be assessed directly postoperative and then every 6 hours till the end of the first 24 hours after surgery. 24 hours
Secondary Outcome First analgesic request 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Suez Canal University Hospitals Ring Road Ismailia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Abdelrahman Solimans. Eslam Albayadi. Mostafa Abdelrahman. Ring Road ismailia 41522 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Ring Road Ismailia 41522 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Abdelrahman Soliman Member of Staff Housing, Building 6 Flat 1 Ismailia 41112 Egypt
Mostafa Mahmoud Ebrahim Abdelrahman Anaesthesia Department, Faculty of Medicine, Suez Canal University Ismailia 41522 Egypt
Eslam Albayadi Anaesthesia Department, Faculty of Medicine, Suez Canal University Ismailia 41522 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abdelrahman Soliman abdul_rahman_ahmed@med.suez.edu.eg +201001104478 Member of Staff Housing
City Postal code Country Position/Affiliation
Ismaillia Egypt Suez Canal University
Role Name Email Phone Street address
Scientific Enquiries Mostafa Abdelrahman m.mahmoud.scuh@gmail.com +201098984116 Anaesthesia Department, faculty of Medicine, Suez Canal University
City Postal code Country Position/Affiliation
Ismailia 41522 Egypt Suez Canal University
Role Name Email Phone Street address
Public Enquiries Mostafa Abdelrahman m.mahmoud.scuh@gmail.com +201098984116 Anaesthesia department, Faculty of Medicine, Suez Canal University
City Postal code Country Position/Affiliation
Ismailia 41522 Egypt Suez Canal university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD that is relative to the results of the primary and secondary outcomes. Statistical Analysis Plan,Study Protocol 6 months after publication Controlled through contact with the investigators through email.
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