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.: PACTR202110576221524 Date of Approval: 07/10/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The analgesic efficacy and opioid sparing effect of erector spinae plane block in scoliosis correction surgery: a randomized controlled trial
Official scientific title The analgesic efficacy and opioid sparing effect of erector spinae plane block in scoliosis correction surgery: a randomized controlled trial
Brief summary describing the background and objectives of the trial Scoliosis correction surgery is a markedly painful procedure that results in severe postoperative pain because of widespread dissection of the skin, subcutaneous tissues, bones, and ligaments (1). The aim of this study is to assess the analgesic efficacy and opioid sparing effect of ESP block in patients undergoing scoliosis correction surgery when used in combination with IV PCA.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/11/2021
Actual trial start date
Anticipated date of last follow up 01/11/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 112
Actual target sample size (number of participants)
Recruitment status Not yet 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 Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ESP block 15 ml of 0.25% bupivacaine with epinephrine 5 mcg/ml will be injected. The volume injected will be calculated to avoid exceeding a total bupivacaine dose of 3 mg/kg (7). Single dose The block will be done bilaterally at two levels. The two levels will be chosen by dividing the length of the planned incision into two and injecting at the approximate midpoint of each half. The level of injection will be identified by palpating C7 spinous process and then counting down. A 22-gauge needle will be inserted in-plane to a linear-array ultrasound transducer attached to ultrasound machine (Chison ECO 1 Expert). The transducer will be placed in a longitudinal direction over the tip of the transverse process. 56
Control Group Intravenous patient controlled analgesia Postoperative analgesia will consist of acetaminophen 1g IV/6h and IV PCA with morphine (initial loading dose 0.05mg/kg, bolus dose 0.03mg/kg, lockout interval 6 min, and no background infusion). 24 hours Postoperative analgesia will consist of acetaminophen 1g IV/6h and IV PCA with morphine (initial loading dose 0.05mg/kg, bolus dose 0.03mg/kg, lockout interval 6 min, and no background infusion). 56 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Either sex Age 10-25 years Idiopathic adolescent scoliosis ASA I or II Scheduled for posterior spinal fusion Patient refusal Advanced liver and kidney disease Congenital heart disease Severe restrictive lung disease Neuromuscular disease Coagulation disorders Psychiatric disturbances local skin infection chronic pain History of hypersensitivity to any of the study drugs Adolescent: 13 Year-18 Year 10 Year(s) 25 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 20/09/2021 Mansoura IRB
Ethics Committee Address
Street address City Postal code Country
Algomhoria St Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Total postoperative morphine consumption will be calculated as the primary outcome. 24 hours
Secondary Outcome Postoperative visual analogue scale (VAS) score, at 2 hours interval for 24 hours 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University Hospital 60, algomhoria St Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Mahmoud Mahdy 44, Eleman St Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Mansoura University Algomhoria St Mansoura Dakahlia Governorate 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Ibrahim Ahmed Abdkarim Elaashry Kfr elshk ataia Sherbeen 35676 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Mahdy drmohamed.mahdy@yahoo.com 00201114781275 44, Eleman St
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt lecturer of Anaesthesia and Surgical ICU Faculty of Medicine Mansoura University Egypt
Role Name Email Phone Street address
Public Enquiries Mohamed Mahdy drmohamed.mahdy@yahoo.com 00201114781275 44, Eleman St
City Postal code Country Position/Affiliation
Mansoura 25516 Egypt Lecturer of Anesthesia and Surgical ICU Faculty of Medicine Mansoura University Egypt
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mahdy drmohamed.mahdy@yahoo.com 00201114781275 44, Eleman St
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of Anesthesia and Surgical ICU Faculty of Medicine Mansoura University Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I will share the study protocol and tables of results within 6 months after finishing the study with any individual or institutional request covered by an appropriate ethical committee Informed Consent Form,Statistical Analysis Plan,Study Protocol Within six months after finishing the study Any communication through an ethical committee or under IRB organization cover
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