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.: PACTR202009465372701 Date of Registration: 01/09/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Erector spinae plane block for inguinal hernia repair in children
Official scientific title Erector spinae plane block versus caudal block in children undergoing inguinal hernia repair: randomized controlled study
Brief summary describing the background and objectives of the trial The most commonly performed inguinal surgeries in children include inguinal hernia repair with or without orchidopexy. Control of post-operative pain is important in pediatric patients because poor pain control may result in increased morbidity or mortality. Regional anesthesia produces excellent post-operative analgesia and attenuation of the stress responses in infants and children. For postoperative pain with these surgeries, a regional analgesic modality such as caudal analgesia, inguinal and iliohypogastric nerve block, or local infiltration is combined with a general anesthetic. The erector spinae plane 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. Recent case studies have reported the use of ESP block for postoperative analgesia in pediatric thoracic and abdominal procedures. The purpose of this randomized, controlled prospective study is to evaluate the analgesic effect of US-guided ESP block in children undergoing elective unilateral inguinal hernia in comparison to the well-established caudal block.
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 15/09/2020
Actual trial start date
Anticipated date of last follow up 15/03/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 141
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
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 0.5 ml/kg of 0.25% isobaric bupivacaine (max 20 ml) once after induction of anesthesia after Patient fasting for 6 hours, and giving premedications, and pre-oxygenation with 100% oxygen for at least 3 minutes, 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 2 min. Maintenance of anesthesia will be carried out by isoflurane and cis-atracurium 0.03 mg/kg guided by neuromuscular monitor. After induction of general anesthesia, US-guided ESPB block will be commenced as follows: The patient will be placed in the lateral position and a high-frequency linear ultrasound transducer will be placed in a longitudinal orientation 1 cm lateral to the thoracic tenth spinous process. The deep plane to the erector spinae muscle will be identified. 0.5 ml/kg of 0.25% isobaric bupivacaine (max 20 ml) will be injected into the interfacial plane between rhomboid major and erector spinae muscles. Hemodynamics will be maintained within 25 % of baseline. Tramadol 0.5 mg/kg will be given intravenously as a rescue analgesic if heart rate or blood pressure increased more than 10% of baseline. Upon completion of wound closure, isoflurane will be discontinued and residual neuromuscular block will be reversed with neostigmine, 0.05 mg/kg IV, and atropine 0.25 mg/kg, IV. The trachea will be extubated when the patient is fully awake. The patients will be kept in PACU unit for close monitoring for 4 hours after recovery. IV paracetamol 15 mg/kg will be given postoperatively if the facial pain scores ≥ 4. The patients were discharged home on a protocol of paracetamol 15 mg/kg oral syrup to be repeated every 6 hours for 48 hours; no postoperative opioids were prescribed for use at home. if pain score still ≥4 after 30 minutes of paracetamol dose, oral ibuprofen 5mg/kg will be given, After patients discharge, contact with the mothers will be done to know the time of the first request of analgesia if wasn’t during hours of hospital stay. 47
Experimental Group Caudal block group 1 ml/kg of 0.25% isobaric bupivacaine(Max 20 ml) once after induction of anesthesia after Patient fasting for 6 hours, and giving premedications, and pre-oxygenation with 100% oxygen for at least 3 minutes, 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 2 min. Maintenance of anesthesia will be carried out by isoflurane and cis-atracurium 0.03 mg/kg guided neuromuscular monitor. After induction of general anesthesia, the caudal block will be commenced as follows: The child will be placed in the left lateral decubitus position. After insertion of a 23-gauge needle into caudal epidural space under the guidance of ultrasound and negative aspiration for blood and cerebrospinal fluid, 1 ml/kg of 0.25% isobaric bupivacaine(Max 20 ml), will be injected.Hemodynamics (blood pressure and heart rate) will be maintained within 25 % of baseline measures. Tramadol 0.5 mg/kg will be given intravenously as a rescue analgesic if heart rate or blood pressure increased more than 10% of baseline. 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. The trachea will be extubated when the patient is fully awake. The patients will be kept in PACU unit for close monitoring for 4 hours after recovery. IV paracetamol 15 mg/kg will be given postoperatively if the facial pain scores ≥ 4. The patients were discharged home on a protocol of paracetamol 15 mg/kg oral syrup to be repeated every 6 hours for 48 hours; no postoperative opioids were prescribed for use at home. if pain scores still ≥4 after 30 minutes of paracetamol dose, oral ibuprofen 5mg/kg will be given, After patients discharge, contact with the mothers will be done to know the time of the first request of analgesia if wasn’t during hours of hospital stay. 47
Control Group control group regular systemic analgesics intraoperative and postoperative after Patient fasting for 6 hours, and giving premedications, and pre-oxygenation with 100% oxygen for at least 3 minutes, 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 2 min. Maintenance of anesthesia will be carried out by isoflurane and cis-atracurium 0.03 mg/kg guided neuromuscular monitor. No regional anesthesia will be performed. Hemodynamics (blood pressure and heart rate) will be maintained within 25 % of baseline measures. Tramadol 0.5 mg/kg will be given intravenously as a rescue analgesic if heart rate or blood pressure increased more than 10% of baseline.Upon completion of wound closure, isoflurane will be discontinued and residual neuromuscular block will be reversed with neostigmine, 0.05 mg/kg IV, and atropine 0.25 mg/kg, IV. The trachea will be extubated when the patient is fully awake. The patients will be kept in the PACU unit for close monitoring for 4 hours after recovery. IV paracetamol 15 mg/kg will be given postoperatively if the facial pain scores ≥ 4. The patients were discharged home on a protocol of paracetamol 15 mg/kg oral syrup to be repeated every 6 hours for 48 hours; no postoperative opioids were prescribed for use at home. if pain scores still ≥4 after 30 minutes of paracetamol dose, oral ibuprofen 5mg/kg will be given , After patients discharge, contact with the mothers will be done to know the time of the first request of analgesia if wasn’t during hours of hospital stay. 47 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Patients aged 2-7 years old. -Consent from parents about the technique and nature of the study. -Patients are ASA I or ASA II -children scheduled for unilateral inguinal hernia repair. -parents’ refusal to participate in the study. -Known allergy to LA. -Local infection. - Underlying coagulopathies. -Congenital spinal anomalies. - Neurologic diseases and serious renal, hepatic, lung, and cardiac diseases. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 2 Year(s) 7 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 13/07/2020 research ethics comittee 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 postoperative pain scores at 1, 4, 8, 12 and 24 hours postoperatively.
Secondary Outcome Intraoperative and postoperative hemodynamics: heart rate, systolic blood pressure, diastolic blood pressure every 5 minutes throughout the procedure ,then every 30 minutes for the next 4 hours after recovery from anaethesia
Secondary Outcome Duration of surgery at the end of surgery
Secondary Outcome Number of patients who needed intraoperative rescue analgesia at the end of surgery
Secondary Outcome 1st request of postoperative analgesia during the first 24 hours after surgery
Secondary Outcome Number of children requesting postoperative analgesics in the first 4 hours postoperatively postoperatively for 4 hours
Secondary Outcome Number of patients requesting postoperative ibuprofen during the first 24 hours after surgery
Secondary Outcome emergence agitation after finishing surgery for 4 hours
Secondary Outcome postoperative nausea and vomitting after finishing surgery for 24 hours
Secondary Outcome parenteral satisfaction about the procedure 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 suez canal university hospital the ring road ,kilo 4.5 ismailia 41522 Egypt University
Secondary Sponsor anaesthesia departement faculty of medicine suez canal university 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 zayed
City Postal code Country Position/Affiliation
ismailia 41522 Egypt lecturer of anesthesia
Role Name Email Phone Street address
Public Enquiries ahmed eliwa ahmedabdelrahman29@gmail.com +201002744572 ard elgameiat,elsheikh zayed
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 zayed
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 all the participant data collected during the trial after deidentification Statistical Analysis Plan,Study Protocol immediately after publication, no end date to achieve aim of the approved proposal
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