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.: PACTR202404481058829 Date of Approval: 09/04/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title analgesia after hypospadias repair in pediatrics
Official scientific title Analgesic Efficacy of Sacral Erector Spinae Plane Block versus Caudal Epidural Block in Pediatrics Patients undergoing Hypospadias Repair
Brief summary describing the background and objectives of the trial The fundamental indicative constituent for any successful clinical procedure is patient satisfaction, which is directly related to post-operative analgesia. In paediatric care, due to the nature of the patient – and depending on the age group – it is often difficult, or even impossible, to fully understand the extent of pain perceived, leading to insufficient pain management. A variety of regional anaesthetic techniques have been thoroughly investigated for the ease of administration, as well as enhanced patient satisfaction. Regional anesthesia (RA) provides excellent pain relief in infants and is performed for operative anesthesia, post- operative analgesia, and the treatment of painful, non-operative traumatic or medical conditions. Postoperative analgesia through the caudal route is considered to be the most appropriate and satisfactory analgesia for small children undergoing anoperineal, inguinal and urogenital surgery. It is usually provided by injecting bupivacaine which is a long acting local anaesthetic. The maximum analgesic effect of bupivacaine is up to 6-12 hours. Erector spinae plane block (ESPB) is a tissue plane block that was first described in adults in 2016. Since its introduction, the ESPB has been used in adults to provide analgesia for a wide range of surgery including open and laparoscopic abdominal and cardiothoracic surgeries, hip arthroplasties, prostatectomies, upper extremity amputations, and cervical spine fusions. An ESPB is performed under ultrasound guidance by injecting local anesthetic deep to the erector spinae muscle, with the goal of hydro dissecting the tissue fascial plane at the level of the transverse processes. The technique has been described using both parasagittal and transverse approaches. This study aims at comparing the perioperative analgesic efficacy of sacral erector spinae plane block versus caudal epidural block in pediatric patients undergoing hypospadias repair.
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: Other
Anticipated trial start date 07/04/2024
Actual trial start date 07/04/2024
Anticipated date of last follow up 07/07/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL Analgesic Efficacy of Sacral Erector Spinae Plane Block versus Caudal Epidural Block in Pediatrics Patients undergoing Hypospadias Repair
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group caudal epidural group The patient will be placed in the left lateral decubitus position, with the hips and knees flexed; the skin of the caudal area will be prepared with povidone iodine 10%. The caudal end of the sacrum will be examined with ultrasound; the transducer will be placed at the midline for a transverse view of the sacral hiatus. After locating the cornua and sacrococcygeal ligament the transducer will be rotated 90 degrees to obtain a longitudinal view of the sacral hiatus. Using the “in-plane” technique, the block needle will be inserted between the cornuae and directly into the sacral canal. After confirming negative cofirmatory aspiration, bupivacaine 0.25% (0.5 ml/kg) will be injected. once The patient will be placed in the left lateral decubitus position, with the hips and knees flexed; the skin of the caudal area will be prepared with povidone iodine 10%. The caudal end of the sacrum will be examined with ultrasound; the transducer will be placed at the midline for a transverse view of the sacral hiatus. After locating the cornua and sacrococcygeal ligament the transducer will be rotated 90 degrees to obtain a longitudinal view of the sacral hiatus. Using the “in-plane” technique, the block needle will be inserted between the cornuae and directly into the sacral canal. After confirming negative cofirmatory aspiration, bupivacaine 0.25% (0.5 ml/kg) will be injected. 20 Active-Treatment of Control Group
Experimental Group scaral erector spinae group Patients will be placed in the prone position for the ESP block. Following skin preparation with povidone iodine 10%, the ultrasound probe will be placed on the L5 spinous process. The probe will then be moved caudally till the sacral medial crest becomes visualized. Here again, the probe will be moved laterally until the sacral intermediate crest is seen. After obtaining the optimum image at the S3 level with the US, a needle will be advanced in a cranio-caudal direction till bone contact is achieved. The needle will be aspirated to exclude inadvertent intravascular tip position. Correct needle position will be additionally confirmed with the administration of 1 ml normal saline (hydrolocalisation). Bupivacaine 0.25% (0.5 ml/kg) will be injected between the multifidus muscle and the intermediate sacral crest. The carino-caudal propagation of the LA and the upward movement of the erector spinae muscle and multifidus muscle will be observed in real time by the US. The same block procedure will be repeated on the other side. 0nce Patients will be placed in the prone position for the ESP block. Following skin preparation with povidone iodine 10%, the ultrasound probe will be placed on the L5 spinous process. The probe will then be moved caudally till the sacral medial crest becomes visualized. Here again, the probe will be moved laterally until the sacral intermediate crest is seen. After obtaining the optimum image at the S3 level with the US, a needle will be advanced in a cranio-caudal direction till bone contact is achieved. The needle will be aspirated to exclude inadvertent intravascular tip position. Correct needle position will be additionally confirmed with the administration of 1 ml normal saline (hydrolocalisation). Bupivacaine 0.25% (0.5 ml/kg) will be injected between the multifidus muscle and the intermediate sacral crest. The carino-caudal propagation of the LA and the upward movement of the erector spinae muscle and multifidus muscle will be observed in real time by the US. The same block procedure will be repeated on the other side. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• All patients within the age range from 1 to 6 years scheduled for hypospadias surgery • ASA I or II physical status. • Refusal of the patient’s parents or legal guardians to give informed consent. • History of allergy to any of the study drugs. • Neurological and/or psychological diseases. • Patients with contraindications to regional anesthesia (coagulopathy, deformities of the spine), • Cardiovascular diseases, or type I diabetes. Preschool Child: 2 Year-5 Year 1 Year(s) 6 Year(s) Male
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 13/07/2023 ethics and research commitee faculty of medicine menoufia university
Ethics Committee Address
Street address City Postal code Country
25 yassin abdelghaffar street , shebin elkom, menoufia, egypt shebin elkom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative pain intensity using modified objective pain scale in PACU, at 2, 4, 6, 8, 12, 16, 20, 24 hours postopertaively
Secondary Outcome Heart Rate and Mean Arterial Pressure before GA induction, after induction, after the study block, at skin incision, and every 15 min from the start of surgery.
Secondary Outcome The time to first analgesic request will be recorded (the time from LA injection to the first analgesic requirement). the time from LA injection to the first analgesic requirement
Secondary Outcome Ramsay sedation score will be assessed 30 minutes after recovery (1 = anxiety and completely awake, 2 = completely awake, 3 = awake but drowsy, 4 = asleep but responsive to verbal commands, 5 = asleep but responsive to tactile stimulus, and 6 = asleep and not responsive to any stimulus). 30 minutes after recovery
Secondary Outcome The adverse effects: hypotension, bradycardia, respiratory depression (the SpO2 <95%), need O2 supplementation, nausea and vomiting. every 1 hour postoperatively
Secondary Outcome Anesthetic requirements (ETsevo) will be recorded before skin incision then every 15 minutes till LMA removal before skin incision then every 15 minutes till LMA removal
Secondary Outcome Intraoperative fentanyl (mic) and postoperative ketorolac (mg) & meperidine (mg) requirements. at the end of surgery, at discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
menoufia university hospitals 25 yassin abdelghaffar street shebin elkom menouifa egypt 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
authors 25 yasin abdelghaffar street shebin elkom 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor anesthesia department 25 yasin abdelghaffar street shebin elkom 32511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator khaled gaballah khgaballah@gmail.com 00201016009073 25 yasin abdelghaffar street
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt assistant professor
Role Name Email Phone Street address
Public Enquiries noha afify nohaafify2014@gmail.com 00201015007654 25 yasin abdelghaffar street
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt assistant professot
Role Name Email Phone Street address
Scientific Enquiries doaa salah doaa23@gmail.com 0020122415485 25 yasin abdelghaffar street
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt anesthesia specialist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all the collected individual patients data after deintification, the study protocol, the statistical analysis plan, the informed writen consent, will be available immediately following publication for researchers who provide metgodologically sound proposal Informed Consent Form,Statistical Analysis Plan,Study Protocol from study start till publication personal contact through nohaafiy2024@gmail.com
URL Results Available Results Summary Result Posting Date First Journal Publication Date
email conact through nohaafiy2024@gmail.com 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