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.: PACTR202011518233885 Date of Approval: 27/11/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound guided spermatic cord block combined with ilioinguinal/iliohypogastric nerve block for postoperative analgesia in children undergoing inguinal hernia repair: a randomized, controlled study
Official scientific title Ultrasound guided spermatic cord block combined with ilioinguinal/iliohypogastric nerve block for postoperative analgesia in children undergoing inguinal hernia repair: a randomized, controlled study
Brief summary describing the background and objectives of the trial Background: Inguinal herniorrhaphy is a common surgical procedure during childhood. The aim of the current study is to compare the postoperative analgesic efficacy spermatic cord block combined with II/IH nerve with II/IH nerve block for postoperative analgesia in children undergoing inguinal hernia. Methods: Eighty patients will be enrolled in this study and will be randomly allocated into 2 equal groups. Spermatic cord (SC) block group: the patients will receive spermatic cord and IIN and IHN blocks and the Control group: the patients will receive only II/IH nerve block. Our primary outcome measure will be the the postoperative analgesic requirement, while the secondary goals will be, time of first rescue analgesia, postoperative pain score, number of patients requiring rescue analgesic and incidence of block related complications.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/12/2020
Actual trial start date 25/12/2020
Anticipated date of last follow up 01/06/2021
Actual Last follow-up date 14/07/2021
Anticipated target sample size (number of participants) 80
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group ilioinguinal iliohpyogastric nerve block 0.2 mL/kg bupivacaine 0.25 % will be injected to block II and IH nerves. After induction of anesthesia The patient will be placed in supine position with complete aseptic precautions. The linear ultrasound probe will be covered with sterile tegaderm and placed immediately medial and slightly cephalic to the upper aspect of the anterior superior iliac spine (ASIS) with its medial end directed towards the umbilicus. A long-axis view will be obtained over ASIS and abdominal muscles (external oblique, internal oblique and transversus abdominis), with the peritoneum immediately beneath the transversus abdominis muscle. The needle (short beveled) will be advanced using an in-plane technique, placing the needle tip 1 cm caudal to the probe to allow for optimal needle tip visibility. Advancement of the needle will be continued till interfascial plane between the internal oblique and transversus abdominis muscles under real-time visualization of the solution surrounding the two hypoechoic II and IH nerves. 40 Active-Treatment of Control Group
Experimental Group Spermatic cord block 0.2 mL/kg bupivacaine 0.25 % After induction of anesthesia For this block, the probe will be placed transversely just lateral to the pubic tubercle, parallel and above the inguinal ligament. At this point the spermatic cord can be easily identified. The probe can also be placed over the femoral vessels and then moved cranially and medially, above the inguinal ligament towards the pubic tubercle till the spermatic cord is easily identified. Once the spermatic cord is identified, a 30mm-block needle will be introduced from the lateral side using in-line approach. It is important to always aspirate before we inject, as there are small vessels located in this region. Once the needle tip is next to the spermatic cord, 0.4 mL/kg bupivacaine 0.25 % will be injected. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Eighty patients of either sex. Their age ranging from 1 to 10 years. Undergoing inguinal herniorraphy. Local infection at the puncture site. A history of clinically significant cardiac, hepatic, renal, or neurological conditions. Known allergy to local anesthetics. Child: 6 Year-12 Year,Infant: 1 Month-23 Month 1 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 04/11/2020 Mansoura Faculty of Medicine Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
2 El Gohorria street Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Our primary outcome measure will be the the number of patients requiring rescue analgesic in the first 6 postoperative hours
Secondary Outcome Mean arterial pressure (MAP) and heart rate (HR) will be recorded at 1, 2, 4, 6 hours post-operatively. The behavioral FLACC (Face, Leg, Activity, Cry, Consolability) pain scale . complications such as nausea or vomiting. first 6 postoperative hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university children hospital 2 El-Gomhouria Street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Ibrahim Abd Elbaser 2 El-Gomhouria Street Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university children hospital 2 El-Gomhouria Street Mansoura 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ibrahim Ibrahim Abd Elbaser 2 El-Gomhouria Street Mansoura 35516 Egypt
El Sayed M El Emam 2 El-Gomhouria Street Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ibrahim Abelbaser ibrahimbaser2010@yahoo.com +201004976825 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Assistant professor of anesthesia and surgical Intensive care at faculty of medicine Mansoura university
Role Name Email Phone Street address
Public Enquiries El Sayed El Emam sayedemam0606@gmail.com +20100875995 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Assistant professor of anesthesia and surgical Intensive care at faculty of medicine Mansoura university
Role Name Email Phone Street address
Scientific Enquiries Khaled El Bhrawy Bahrawy2010@gmail.com +201121011768 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of Anesthesia and Surgical Intensive Care at Mansoura University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will provide individual participant data and share it through the PubMed indexed journal Informed Consent Form,Study Protocol Beginning 6 months and ending 12 months following article publication We will provide individual participant data and share it through the PubMed indexed journal
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