Analgesic Efficacy of Ultrasound Guided Bilateral Erector Spinae Plane Block in Pediatric.
NCT ID: NCT04452656
Last Updated: 2021-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
98 participants
INTERVENTIONAL
2020-07-20
2021-08-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Randomization will be achieved by using an online random number generator. Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. A medical personnel not involved in patient management will be responsible for opening the envelope and give the instructions contained within each envelope to the anesthesiologist who is expert in doing the ESP block in patients included within the block group. The anesthesia team who managed the patients intraoperatively did not share in recording data for the research. However, another physcian will be responsible for recording the intraoperative data.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
bilateral erector spinae plane block
The patient WILL receive bilateral erector spinae plane block.
bilateral erector spinae block
An ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T3 spinous process corresponding to the T2 transverse process.
Three muscles; trapezius , rhomboids major , and erector spinae will be identified superior to the hyperechoic transverse process.
Using in-plane approach a 25 G needle will be inserted in caudal-cephalad direction, until the tip is deep to erector spinae muscle.
Correct needle tip location will be confirmed by injecting 3 mL of saline and visualizing the linear LA spread in the fascial plane between the erector spinae muscle and the transverse process..
0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) will be injected and visualizing the linear LA spread in the fascial plane between the erector spinae muscle andthe transverse process12.
NO BLOCK
The patient will not receive Erector spinae plane block
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
bilateral erector spinae block
An ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T3 spinous process corresponding to the T2 transverse process.
Three muscles; trapezius , rhomboids major , and erector spinae will be identified superior to the hyperechoic transverse process.
Using in-plane approach a 25 G needle will be inserted in caudal-cephalad direction, until the tip is deep to erector spinae muscle.
Correct needle tip location will be confirmed by injecting 3 mL of saline and visualizing the linear LA spread in the fascial plane between the erector spinae muscle and the transverse process..
0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) will be injected and visualizing the linear LA spread in the fascial plane between the erector spinae muscle andthe transverse process12.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* ASA, American Society of Anesthesiology, II and III .
* Patients undergoing cardiac surgeries with midline sternotomy incision.
Exclusion Criteria
* Preoperative mechanical ventilation.
* Preoperative inotropic drug infusion.
* Known or suspected coagulopathy.
* Any congenital anomalies of the sacrum/the vertebral column or any infection at the site of injection.
* Known or suspected allergy to any of the studied drugs.
* Elevated liver enzymes more than the normal values.
* Renal function impairment (Creatinine value more than 1.2 mg/dl or BUN more than 20mg/dl).
6 Months
7 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
AHMED ALI GADO
Director
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cairo University Hospitals
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Anand VG, Kannan M, Thavamani A, Bridgit MJ. Effects of dexmedetomidine added to caudal ropivacaine in paediatric lower abdominal surgeries. Indian J Anaesth. 2011 Jul;55(4):340-6. doi: 10.4103/0019-5049.84835.
Anand KJ, Hickey PR. Halothane-morphine compared with high-dose sufentanil for anesthesia and postoperative analgesia in neonatal cardiac surgery. N Engl J Med. 1992 Jan 2;326(1):1-9. doi: 10.1056/NEJM199201023260101.
El Shamaa HA, Ibrahim M. A comparative study of the effect of caudal dexmedetomidine versus morphine added to bupivacaine in pediatric infra-umbilical surgery. Saudi J Anaesth. 2014 Apr;8(2):155-60. doi: 10.4103/1658-354X.130677.
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
Kaushal B, Chauhan S, Magoon R, Krishna NS, Saini K, Bhoi D, Bisoi AK. Efficacy of Bilateral Erector Spinae Plane Block in Management of Acute Postoperative Surgical Pain After Pediatric Cardiac Surgeries Through a Midline Sternotomy. J Cardiothorac Vasc Anesth. 2020 Apr;34(4):981-986. doi: 10.1053/j.jvca.2019.08.009. Epub 2019 Aug 12.
Munoz F, Cubillos J, Bonilla AJ, Chin KJ. Erector spinae plane block for postoperative analgesia in pediatric oncological thoracic surgery. Can J Anaesth. 2017 Aug;64(8):880-882. doi: 10.1007/s12630-017-0894-0. Epub 2017 Apr 26. No abstract available.
De la Cuadra-Fontaine JC, Concha M, Vuletin F, Arancibia H. Continuous Erector Spinae Plane block for thoracic surgery in a pediatric patient. Paediatr Anaesth. 2018 Jan;28(1):74-75. doi: 10.1111/pan.13277. No abstract available.
Hernandez MA, Palazzi L, Lapalma J, Forero M, Chin KJ. Erector Spinae Plane Block for Surgery of the Posterior Thoracic Wall in a Pediatric Patient. Reg Anesth Pain Med. 2018 Feb;43(2):217-219. doi: 10.1097/AAP.0000000000000716.
Ueshima H, Otake H. RETRACTED: Clinical experiences of erector spinae plane block for children. J Clin Anesth. 2018 Feb;44:41. doi: 10.1016/j.jclinane.2017.10.021. No abstract available.
Kaplan I, Jiao Y, AuBuchon JD, Moore RP. Continuous Erector Spinae Plane Catheter for Analgesia After Infant Thoracotomy: A Case Report. A A Pract. 2018 Nov 1;11(9):250-252. doi: 10.1213/XAA.0000000000000799.
Hernandez MA, Palazzi L, Lapalma J, Cravero J. Erector spinae plane block for inguinal hernia repair in preterm infants. Paediatr Anaesth. 2018 Mar;28(3):298-299. doi: 10.1111/pan.13325. Epub 2018 Jan 17.
Merkel S, Voepel-Lewis T, Malviya S. Pain assessment in infants and young children: the FLACC scale. Am J Nurs. 2002 Oct;102(10):55-8. doi: 10.1097/00000446-200210000-00024. No abstract available.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
N159-2020
Identifier Type: -
Identifier Source: org_study_id