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.: PACTR202008747853344 Date of Approval: 14/08/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title ESPB vs QLB for Analgesia in Pediatric Major Abdominal Surgeries
Official scientific title Erector Spinae Plane Block Versus Quadratus Luborum Block for Peri-Operative Analgesia in Major Abdominal Surgeries in Pediatric Patients; a Randomized Controlled Study
Brief summary describing the background and objectives of the trial Pain after major abdominal surgeries is common, and if not correctly managed, postoperative pain increases the incidence of postoperative complications. Ultrasound guided fascial plane blocks allow deposition of local anesthetics near a targeted group of nerves. In our study, we aimed to compare the analgesic effect of Erector Spinae Plane Block (ESPB) versus Quadratus Luborum Block (QLB) in pediatric patients who underwent unilateral abdominal surgeries.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/01/2019
Actual trial start date 27/01/2019
Anticipated date of last follow up 27/07/2019
Actual Last follow-up date 02/02/2020
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants) 36
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 QLB group After induction of general anesthesia and before skin incision Quadratus lumborum block (QLB) was performed in the lateral decubitus position and each patient turned on his/ her side so that the blocked side was the uppermost one with operator facing patient’s back. Strict sterile techniques were implemented, skin sterilization with povidone iodine of the site of needle entry was performed .The lateral and post abdominal wall was scanned aiming to identify the QL muscle seen as a superior leaf of the Shamrock sign at the transverse process of L4. Depending on the individual anatomy, scanning was started posteriorly from the midline laterally, at or above L4 transverse process level, or anteriorly at the anterior axillary immediately above the iliac crest. Then, the probe moved to the mid axillary line aiming to visualize tapering of the three muscle layers. Scanning was continued to the posterior axillary line aiming to visualize the origin of the internal oblique and transverses abdominus muscles from the thoracolumbar fascia with the QL muscle immediately medial. A 22 G echogenic needle was inserted in plane from the posterior (medial) end of the probe and directed for the fascial plane between the QL and the PM muscles through the QL muscle. Once the needle is confirmed in correct location, 1 mL of saline will be injected after negative aspiration. Then 0.5 mL/Kg of bupivacaine 0.25% will be injected (Sunnypivacaine 0.5%, Sunny Pharmaceutical, Egypt) not exceeding the maximum recommended dose (2 mg/kg of for bupivacaine). The spread of the injectate was observed to distribute within this plane. Then patient turned to the proper surgical position again and surgery was commenced. N.B: All the blocks were performed after induction of anesthesia and under ultrasound guidance. All the blocks were performed by the same investigator. The ultrasound machine used is S-Nerve Ultrasound System P07576, USA with SL Ax/6-13 MHz linear high frequency transducer. 12
Experimental Group ESPB group After induction of general anesthesia and before skin incision A unilateral erector spinae plane block was performed in the lateral decubitus position and each patient turned on his/ her side so that the blocked side was the uppermost one. Strict sterile techniques were implemented; skin sterilization with povidone iodine of the site of needle entry wasperformed.The T7 spinous process located by palpating and counting down from the C7 spinous process. The ultrasound probe was placed in a transverse orientation at this level to identify the tip of the T7 transverse process. The tip of the transverse process was centered on the ultrasound screen and the probe was then be rotated 90º into a longitudinal orientation to produce a parasagittal view approximately 2-2.5 cm from the midline, in which the following layers will be visible superficial to the acoustic shadows of the transverse processes: skin, subcutaneous tissue; trapezius; and erector spinae muscle. Visualization of the pleura between T12 and adjacent transverse processes was obtained before needle insertion. A 22G 50-mm echogenic block needle (Pajunk Sonoplex, Geisingen, Germany) was inserted in-plane to the ultrasound beam in a cranial-to-caudal direction until contact is made with the T7 transverse process. Correct location of the needle tip in the fascial plane deep to erector spinae muscle was confirmed by injecting 0.5-1 ml saline and seeing the fluid lifting the erector spinae muscle off the transverse process i.e. hydrodissection. Once the needle was in correct location, a negative aspiration test will be confirmed. Then 0.5 mL/Kg of bupivacaine 0.25% (Sunnypivacaine 0.5%, Sunny Pharmaceutical, Egypt) was injected t not exceeding the maximum recommended dose (2 mg/kg of for bupivacaine). The spread of the injectate was observed to distribute within this plane. Then patient was turned to the proper surgical position again and surgery was commenced. 12
Control Group LWI group After induction of general anesthesia and before skin incision Local wound infiltration group (LWI): The site of surgical incision was infiltrated before surgical incision by subcutaneous injection of 0.5 mL/Kg bupivacaine 0.25% (Sunnypivacaine 0.5%, Sunny Pharamaceutical, Egypt) taking care not exceeding the maximum recommended dose (2 mg/kg of for bupivacaine).Infiltration was done in the same surgical position after induction of general anesthesia. 12 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children age starting from 4 to12 years. Genders eligible for study: both sexes. ASA I-II. Scheduled to undergo a unilateral major abdominal surgery (e.g. spleenectomy , nephrectomy , colostomy closure etc) Refusal of participation by parents or caregivers Patients requiring emergency procedures. Known local anesthetic (LA) drug sensitivity Bleeding disorders with INR > 1.5 and/or platelets < 100,000/mm3. Skin lesions or wounds at site of proposed needle insertion. Evidence of peritonitis or septicemia. Hepatic disease or enlargement. Children with congenital heart disease. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 3 Year(s) 12 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 23/09/2018 Research Ethics Committee Faculty of Medicine Cairo University
Ethics Committee Address
Street address City Postal code Country
El Saray street Manial Cairo 11956 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Time in minutes to 1st request of rescue analgesia in PACU and defined by pain score ˃4/10. started 15 min after extubation
Secondary Outcome Pain score assessed by Wong-Baker Faces Scale . Score ranges from 0 to 10 with 0 means no pain and 10 means worst pain imaginable. at the following intervals: 15, 30, 45 and 60 min, 6, and 12 hours after surgery post-extubation
Secondary Outcome Block failure rate where the block was considered a failed block when the patient required more than two doses of rescue analgesia in the first hour postoperatively. during the 1st hour post-extubation
Secondary Outcome Number of doses of rescue analgesia post-extubation up to 60 min postoperatively
Secondary Outcome Onset and incidence of complications, such as: - Intraoperative bradycardia (decrease in heart rate ˃ 20% of baseline value), hypotension (decrease in systolic blood pressure ˃ 20% baseline value) - Postoperative nausea and vomiting, urinary retention (inability to pass urine even once during the first 24 hours), lower limb weakness - Injury to the underlying structures (injury to the liver or a viscus), or hematoma formation as recorded under ultrasound guidance - Need of postoperative mechanical ventilation or ICU admission - LA toxicity. intraoperative and postoperative
Secondary Outcome Hemodynamic parameters (heart rate, systolic and mean arterial blood pressure) 5 min after intubation, 5 min after block injection, 15 min after skin incision, 30 min after skin incision, 60 min after skin incision, 90 min after skin incision, 5 min after extubation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kasr Alainy Hospital Cairo University El Saray street Manial Cairo 11956 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Kasr Alainy Hospital Faculty of Medicine Cairo University El Saray street Manial Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kasr Alainy Hospital Faculty of Medicine Cairo Univesity El Saray Manial Cairo 11956 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ahmad Mahmoud Hussein Al Maryotteya AL Harm Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Reham Saleh rhsaleh@yahoo.com +201223938594 9th Maadi
City Postal code Country Position/Affiliation
Cairo Egypt MD Professor Faculty of Medicine Cairo University
Role Name Email Phone Street address
Principal Investigator Sherif Soaida sherif_soida@kasralainy.edu.eg +201223663504 Hadaek Al Ahram
City Postal code Country Position/Affiliation
Giza Egypt MD Assisstant professor Faculty of Medicine Cairo University
Role Name Email Phone Street address
Public Enquiries Ahmad Hussein ahmadhussien057@gmail.com +201229550989 Al Maryotteya
City Postal code Country Position/Affiliation
Giza Egypt Msc assistant lecture Faculty of Medicine Cairo Univerity
Role Name Email Phone Street address
Scientific Enquiries Hany Mohammed oblfollower_2001@yahoo.com +201003066806 10th A Hadaek Al Ahram
City Postal code Country Position/Affiliation
Giza Egypt MD Lecturer Faculty of Medicine Cairo University
Role Name Email Phone Street address
Scientific Enquiries Tamer Rouk tamer_rouk@yahoo.com +201006216826 Mayo
City Postal code Country Position/Affiliation
Cairo Egypt MD Lecturer Faculty of Medicine Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes de-identified demographic data for each participant such as age, sex, weight, medical condition, interventions done and outcomes Statistical Analysis Plan,Study Protocol start: 15-8-2020 end: 15-1-2021 open access statistical data analysis permitted data requisition will be by email corresponding author will decide reviewing request according to quality
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