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The goal of this prospective study is to is to evaluate the perioperative pain management of Erector Spinae Block versus Caudal Block using the Face, Legs, Activity, Cry, Conceal ability (FLACC) Pain Scale inn children aged 2 to 7 years old. The main question it aims to answer is:
Which block is more efficient in the perioperative period?
Participants will be evaluated intraoperative and postoperative for hemodynamic changes and their pain will evaluated according to the FLACC score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caudal Block Group | Active Comparator | Patients who received ultrasound guided Caudal Block |
|
| Erector Spinae Plane Block Group | Active Comparator | Patients who received ultrasound guided Erector Spinae Block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound Guided Bilateral single shot Erector Spinae Plane Block | Procedure | Ultrasound Guided Erector Spinae Plane block given bilaterally at level of L1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compare the efficacy of postoperative pain management of Erector Spinae Block versus Caudal Block. | Evaluate postoperative pain using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. A score of 0 = no pain, 10 = severe pain. A score ≥4 requires rescue analgesia. | At 15 minutes and 30 minutes in PACU, then every 2 hours up to 8 hours after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes to heart rate (beats/minute) | Changes to heart rate (beats/minute) recorded before surgery, during surgery and immediately after surgery | T0: before induction of anesthesia T1: after induction of anesthesia (within 5 minutes) T2: immediately after block placement (within 5 minutes) T3: start of surgery T4: every 10 minutes intraoperative until the end of surgery T5: end of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashraf A Abdelhalim, Doctorate | Professor of Anesethia and Surgical Intensive Care. | Study Chair |
| Ahmed M El Attar, Doctorate | Professor of Anesethia and Surgical Intensive Care. | Study Director |
| Aliaa R Abdel Aziz, Doctorate | Assistant Professor of Anesethia and Surgical Intensive Care. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| El Shatby University Hospital for Children | Alexandria | EL Shatby | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31602352 | Background | Aksu C, Gurkan Y. Defining the Indications and Levels of Erector Spinae Plane Block in Pediatric Patients: A Retrospective Study of Our Current Experience. Cureus. 2019 Aug 8;11(8):e5348. doi: 10.7759/cureus.5348. | |
| 7772368 | Background | Aldrete JA. The post-anesthesia recovery score revisited. J Clin Anesth. 1995 Feb;7(1):89-91. doi: 10.1016/0952-8180(94)00001-k. No abstract available. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 10, 2024 | Nov 19, 2025 |
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|
| Caudal Block Anesthesia | Procedure | Ukltrasound Guided Caudal Epidural Block |
|
| The time to first rescue analgesic. | Time from block administration to the patient's first requirement for rescue analgesia. | from 0 to 8 hours after block administration |
| Total postoperative analgesic requirements. | Amount and frequency of analgesia patient requested | from 0 to 8 hours after block administration |
| Parent satisfaction with a 5-point Likert scale questionnaire. | Parent or caregiver satisfaction about block efficiency on a scale of 1 to 5. | At 8 hours after block administration |
| Number of patients required rescue analgesic postoperatively. | Number of patiebts of asked for rescue analgesia is recorded. | From 0 to 8 hours after surgery. |
| Time to Modified Aldrete score ≥9. | Postoperative recovery was assessed using the Modified Aldrete Scoring System, which evaluates five physiological criteria: activity, respiration, circulation, consciousness, and oxygen saturation | from arrival to PACU (0 hours) until achieving an Aldrete score ≥9 (expected within 60 minutes) |
| Incidence of any adverse effects. | Any side effects reported by the patient related to analgesia. | from end of surgery (0 hours) to 8 hours postoperatively |
| Changes to mean arterial pressure (MAP) | changes to mean arterial pressure (MAP) (mmHg) before surgery, during surgery and immediately after surgey | T0: before induction of anesthesia T1: after induction of anesthesia (within 5 minutes) T2: immediately after block placement (within 5 minutes) T3: start of surgery T4: every 10 minutes intraoperative until the end of surgery T5: end of surgery |
| Changes to oxygen saturation | Changes to oxygen saturation before surgery, during surgery and immediately after surgery. | T0: before induction of anesthesia T1: after induction of anesthesia (within 5 minutes) T2: immediately after block placement (within 5 minutes) T3: start of surgery T4: every 10 minutes intraoperative until the end of surgery T5: end of surgery |
| 19352161 | Background | Chanthong P, Abrishami A, Wong J, Herrera F, Chung F. Systematic review of questionnaires measuring patient satisfaction in ambulatory anesthesia. Anesthesiology. 2009 May;110(5):1061-7. doi: 10.1097/ALN.0b013e31819db079. |
| 35790215 | Background | Lucente M, Ragonesi G, Sanguigni M, Sbaraglia F, Vergari A, Lamacchia R, Del Prete D, Rossi M. Erector spinae plane block in children: a narrative review. Korean J Anesthesiol. 2022 Dec;75(6):473-486. doi: 10.4097/kja.22279. Epub 2022 Jul 5. |
| 27501016 | Background | 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. |
| 34349375 | Background | Kollipara N, Kodali VRK, Parameswari A. A randomized double-blinded controlled trial comparing ultrasound-guided versus conventional injection for caudal block in children undergoing infra-umbilical surgeries. J Anaesthesiol Clin Pharmacol. 2021 Apr-Jun;37(2):249-254. doi: 10.4103/joacp.JOACP_361_19. Epub 2021 Jul 15. |
| 24722013 | Background | Chen CP, Lew HL, Tang SF. Ultrasound-guided caudal epidural injection technique. Am J Phys Med Rehabil. 2015 Jan;94(1):82-4. doi: 10.1097/PHM.0000000000000047. No abstract available. |
| 35460068 | Background | Opfermann P, Kraft F, Obradovic M, Zadrazil M, Schmid W, Marhofer P. Ultrasound-guided caudal blockade and sedation for paediatric surgery: a retrospective cohort study. Anaesthesia. 2022 Jul;77(7):785-794. doi: 10.1111/anae.15738. Epub 2022 Apr 22. |
| 28337460 | Background | Kao SC, Lin CS. Caudal Epidural Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:9217145. doi: 10.1155/2017/9217145. Epub 2017 Feb 26. |
| 11481590 | Background | Lamontagne LL, Hepworth JT, Salisbury MH. Anxiety and postoperative pain in children who undergo major orthopedic surgery. Appl Nurs Res. 2001 Aug;14(3):119-24. doi: 10.1053/apnr.2001.24410. |
| 27525299 | Background | Victoria NC, Murphy AZ. Exposure to Early Life Pain: Long Term Consequences and Contributing Mechanisms. Curr Opin Behav Sci. 2016 Feb;7:61-68. doi: 10.1016/j.cobeha.2015.11.015. |
| 16882820 | Background | Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920. |
| Background | Gehdoo Rp. Post operative pain management in paediatric patients. IndianJ Anaesth 2004; 48(5):406-14. |
| 23716315 | Background | Smith HA, Berutti T, Brink E, Strohler B, Fuchs DC, Ely EW, Pandharipande PP. Pediatric critical care perceptions on analgesia, sedation, and delirium. Semin Respir Crit Care Med. 2013 Apr;34(2):244-61. doi: 10.1055/s-0033-1342987. Epub 2013 May 28. |
| 30284240 | Background | Birnie KA, Noel M, Chambers CT, Uman LS, Parker JA. Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database Syst Rev. 2018 Oct 4;10(10):CD005179. doi: 10.1002/14651858.CD005179.pub4. |
| 26677915 | Background | Ingelmo P, Rivera G, Baird R. Pain control after pediatric surgery: learning from the past to perfect the future. Pain Manag. 2016;6(1):9-12. doi: 10.2217/pmt.15.51. Epub 2015 Dec 17. No abstract available. |
| 35793181 | Result | Abdelrazik AN, Ibrahim IT, Farghaly AE, Mohamed SR. Ultrasound-guided Erector Spinae Muscle Block Versus Ultrasound-guided Caudal Block in Pediatric Patients Undergoing Lower Abdominal Surgeries. Pain Physician. 2022 Jul;25(4):E571-E580. |
| Prot_000.pdf |