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.: PACTR201707002381384 Date of Approval: 27/06/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Spinae Plane Block for pediatric splenectomy
Official scientific title Ultrasound guided Erector Spinae Plane Block for postoperative analgesia in pediatric patients undergoing splenectomy; a prospective randomized controlled study
Brief summary describing the background and objectives of the trial Regional anesthesia is an indispensable component of the practice of pediatric anesthesia. While neuraxial techniques have a robust history in pediatric anesthesia, peripheral regional anesthesia has more recently gained popularity. In the last decade, the utilization of peripheral nerve blockade in children has increased tremendously 1. This expansion was in part due to the recognition of the need for better modalities of pain management in children as well as the demonstration of the safety of peripheral regional anesthesia in children 2. The escalation in peripheral nerve blockade was also greatly influenced by the increased availability and advancements of ultrasound technology. The variable neural anatomy and proximity of vascular structures in children make landmark based and nerve stimulator-guided approaches to peripheral nerve blockade more challenging than in adults3. The ultrasound-guided erector spinae plane (ESP) block is a recently described regional anesthetic technique for providing thoracic analgesia when performed at the level of the T5 transverse process. Local anesthetic injected into the fascial plane deep to the erector spinae muscle spreads in a craniocaudal fashion over several levels. Local anesthetic also penetrates anteriorly through the intertransverse connective tissue and enters the thoracic paravertebral space where it can potentially block not only the ventral and dorsal rami of spinal nerves but also the rami communicantes that transmit sympathetic fibers 4,5. Coupled with the fact that the erector spinae muscle and ESP extend down to the lumbar spine, this suggests that the ESP block could result in both visceral and somatic abdominal analgesia if the injection were performed at a lower thoracic level 5. The aim of the current study is to evaluate the effects of bilateral ultrasound guided erector spinae plane block on postoperative analgesia in pediatric patients undergoing splenectomy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Paediatrics,postoperative pain,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/05/2017
Actual trial start date 25/07/2017
Anticipated date of last follow up 01/11/2017
Actual Last follow-up date 03/05/2018
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
31511/04/17 Tanta University, Faculty of Medicine,Research Ethics Committee, Quality Assurance Unit
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 randomisation Sealed opaque envelopes 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 Control group ( C ) a bilateral sham ESPB using 0.3 ml/kg normal saline. once bilateral sham ESPB 30 Placebo
Experimental Group Erector Spinae Plane Block group ( ESPB ): 0.3 ml/kg 0.5% bupivacaine with maximum volume not exceeding 20 ml on both sides and a maximum dose of bupivacaine of 2 mg/kg. once Erector Spinae Plane Block 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
aged 3-10 years, of either gender, ASA I-II, undergoing elective open splenectomy parental refusal, allergy to the study drugs, any contraindication to regional anesthesia e.g. infection at injection site or coagulopathy 3 Year(s) 10 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 01/04/2017 Tanta University, Faculty of Medicine, Research Ethics Committee, Quality Assurance Unit
Ethics Committee Address
Street address City Postal code Country
10 Algeish street Tanta 31951 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Quality of analgesia (CHEOPS scale) immediately after transfer to PACU 1h, 2h, 4h, 6h, 12h and 24 h.
Secondary Outcome total postoperative rescue analgesic consumption 24 h postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University, Faculty of Medicine 10 Algeish street Tanta 31951 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University, Faculty of Medicine 10 Algeish street Tanta 31951 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Department of anesthesia and surgical ICU 10 Algeish street Tanta 31951 Egypt Hospital
Primary Sponsor Tanta University, Faculty of Medicine 10 Algeish street Tanta 31951 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Shaimaa Farouk 1 Moheb street Almahalla Alkobra 31951 Egypt
Mohamed Mohye Eldin 55 Stad street Tanta 31951 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shaimaa Farouk Shaimaafarouk7777@yahoo.com 01270440771 1 Moheb street
City Postal code Country Position/Affiliation
Almahalla Alkobra 31951 Egypt Lecturer ofanesthesia and ICU
Role Name Email Phone Street address
Public Enquiries Mohamed Mohye Eldin Mohd_yazed75@yahoo.com 01120014472 55 Stad street
City Postal code Country Position/Affiliation
Tanta 31951 Egypt Lecturer ofanesthesia and ICU
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mohye Eldin Mohd_yazed75@yahoo.com 01120014472 55 Stad street
City Postal code Country Position/Affiliation
Tanta 31951 Egypt Lecturer ofanesthesia and ICU
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information