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.: PACTR202306690104069 Date of Approval: 27/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of addition of different additives: Magnesium Sulfate and Dexamethasone versus plain Bupivacaine in Ultrasound guided Erector Spinae Plane Block in Pediatrics undergoing repair of Inguinal Hernia.
Official scientific title Effect of addition of different additives: Magnesium Sulfate and Dexamethasone versus plain Bupivacaine in Ultrasound guided Erector Spinae Plane Block in Pediatrics undergoing repair of Inguinal Hernia.
Brief summary describing the background and objectives of the trial This study is aiming to compare the effect of adding different additives to ultrasound guided erector spinae plane block in pediatrics undergoing repair of inguinal hernia. Erector spinae plane block (ESP) is a new paraspinal interfascial technique aims to deposit local anesthetics between the thoracic transverse process and erector spinae muscle block. Erector spinae plane block since then was used in wide range of surgeries of thoracic, upper and lower abdominal and it was introduced in challenging chronic pain conditions such as complex regional pain syndromes and failed back surgery pain ESP performed at the level of T5 was used for thoracic surgery, while at the level of T7 can be used for abdominal surgery in which ESP was found to be effective in blocking visceral pain as well as somatic pain in laparoscopic abdominal surgery. Different additives were added to ESP to enhance and prolong its effect The use of ESP block was evaluated in many studies in pediatric surgeries where the pain score was difficult to assess and the use of postoperative use of rescue analgesia was the objective parameter of assessing the efficacy of the technique in controlling postoperative pain
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 Ultrasound guided ESP plain versus different additives mg and Dexa in pediatrics undergoing inguinal hernia
Anticipated trial start date 25/02/2022
Actual trial start date 07/03/2022
Anticipated date of last follow up 25/02/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 68
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
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 Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Erector spinea block in pediatrics by plain bupivacine 0.5 ml/kg Bupivacaine 0.25% (for each 1ml bupivacaine 0.5% diluted by 1ml normal saline) After intubation before skin incision by 20 minutes the patient will be positioned in the lateral position with the injection side in the upper orientation according to the side of inguinal hernia repair surgery. Following skin disinfection, identification of seventh cervical vertebrae will be followed by the use of the ultrasound straight probe of 2-5 megahertz (sonosite) placed in the parasagittal line and moving down in a longitudinal plane to visualize the seventh transverse process (T7) over lied by the trapezius and the erector spinae muscle where a 22 gauge, 2 inch needle will be inserted in plane until the tip reaches the plane between the erector spinae muscle and the T7 transverse process were 0.5 to 1ml of normal saline will be injected to confirm plane of injection. 23 Active-Treatment of Control Group
Experimental Group Erector spinae block by bupivacine and magnesium 0.5ml/kg mixture of 0.25% bupivacaine and 10% magnesium sulfate in ratio 1:1 After intubation and before skin incsion by 20 minutes the patient will be positioned in the lateral position with the injection side in the upper orientation according to the side of inguinal hernia repair surgery. Following skin disinfection, identification of seventh cervical vertebrae will be followed by the use of the ultrasound straight probe of 2-5 megahertz (sonosite) placed in the parasagittal line and moving down in a longitudinal plane to visualize the seventh transverse process (T7) over lied by the trapezius and the erector spinae muscle where a 22 gauge, 2 inch needle will be inserted in plane until the tip reaches the plane between the erector spinae muscle and the T7 transverse process were 0.5 to 1ml of normal saline will be injected to confirm plane of injection. 23
Experimental Group Erector spinae block using dexamesthasone added to bupivacaine 0.5 ml/kg mixture of 0.25% bupivacaine and Dexamethasone 0.2mg/kg diluted in normal saline After intubation and before skin incision by 20 minutes the patient will be positioned in the lateral position with the injection side in the upper orientation according to the side of inguinal hernia repair surgery. Following skin disinfection, identification of seventh cervical vertebrae will be followed by the use of the ultrasound straight probe of 2-5 megahertz (sonosite) placed in the parasagittal line and moving down in a longitudinal plane to visualize the seventh transverse process (T7) over lied by the trapezius and the erector spinae muscle where a 22 gauge, 2 inch needle will be inserted in plane until the tip reaches the plane between the erector spinae muscle and the T7 transverse process were 0.5 to 1ml of normal saline will be injected to confirm plane of injection. 23
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
o Age: 1 to 7 years o Children within normal weight for age percentiles for 1 to 7 years o Children of either sexes undergoing inguinal hernia will be included in the study. o Parents refusing to participate in the study. o Children with coagulation disorders. o Hypersensitivity to study medications. o Developmental or mental delay. o Skin lesions or infection at the planned site of needle insertion. o Any patient with major comorbid diseases e.g.: cardiac or renal diseases Preschool Child: 2 Year-5 Year 12 Month(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 07/01/2022 Research Ethics committee
Ethics Committee Address
Street address City Postal code Country
Abbasya cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative assessment by Children's hospital eastern Ontario pain scale which assess patient according to Parameters :cry from 1 to 3,facial from 0 to 2,child verbal from 0 to 2 , Torso from 1 to 2,Touch from 1 to 2,Legs from 1 to 2 , if the scale is more than 5 at 1 hour, 2, 4, 8, 16 and 24 hours intervals postoperative a dose of 10mg/kg of paracetamol suppository will be given as a rescue analgesia Time to first dose paracetamol as a postoperative rescue analgesia for each group will be recorded. The total dose of fentanyl that will be used as a rescue intraoperative analgesia if needed will be recorded for each group. The total dose of paracetamol that will be given postoperative as rescue analgesia will be recorded 24 hours postoperatively
Secondary Outcome Safety profile of technique and incidence of complications between the three groups Intra operative and Postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El Demerdash hospital Ain shams university faculty of medicine 38 Abbassia Square, Next to Al-Nour Mosque, Cairo, Egypt Cairo 1181 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Principle investigator Zahraa nasr city 2150 Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine 38 Abbassia Square, Next to Al-Nour Mosque, Cairo, Egypt Cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Fatma Ahmed Mostafa Aref Nasr city zahraa 2150 Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Fatma Aref fatmaaref6@gmail.com +0201062932835 zahra nasr city
City Postal code Country Position/Affiliation
nasr city Egypt assisstant lecturer at department of anesthsia faculty of medicine ain shams university
Role Name Email Phone Street address
Principal Investigator nabila AbdelAziz zukass2001@yahoo.com +201001377772 tagmoa
City Postal code Country Position/Affiliation
cairo Egypt professor of anaesthsia of facutly of medicine ain shams university
Role Name Email Phone Street address
Scientific Enquiries niven Fahmy Nivengerges@hotmail.com +201005282785 masr el gedida
City Postal code Country Position/Affiliation
cairo Egypt assisstant professor at department of anesthsia faculty of medicine ain shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of individual participant data collected during trail after identification Statistical Analysis Plan following puplication any purpose
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