Local Analgesia Via InfiltrationNCT07281235
Perioperative Analgesia Using Ultrasound Guided Erector Spinae Block vs Ultrasound Guided Caudal Block for Pain Control in Children Aged 2-7 Years Undergoing Lower Abdominal Surgery
A study testing Ultrasound Guided Bilateral single shot Erector Spinae Plane Block and Caudal Block Anesthesia in people with Local Analgesia Via Infiltration and Caudal Epidural Anesthesia, run by Alexandria University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Local Analgesia Via Infiltration, Caudal Epidural Anesthesia, Caudal Block
- What is being tested?
- Ultrasound Guided Bilateral single shot Erector Spinae Plane Block and Caudal Block Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age between 2-7 years old.
- ASA I-II.
- Elective surgery under general anaesthesia.
- Lower abdominal surgery.
Who cannot join
- Parent/caregiver refusal.
- Allergy to one of the study medications.
- Renal or cardiac disease.
- Infection or redness at the site of injection.
- Clinically significant coagulopathy.
- Spinal anomalies.
Show all 10Show fewer
- Altered mental status.
- Developmental delay.
- Additional surgery at different surgical sites.
- Block failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Analgesia With Ultrasound Guided Erector Spinae Block Versus Ultrasound Guided Caudal Block in Children
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.
- Conditions
- Local Analgesia Via Infiltration, Caudal Epidural Anesthesia, Caudal Block, Caudal Block for Postoperative Analgesia, Caudal Anesthesia, Erector Spinae Plane Block
- Being tested
- Ultrasound Guided Bilateral single shot Erector Spinae Plane Block, Caudal Block Anesthesia
- Keywords
- Erector Spinae Block, Caudal Block, Pediatrics, llower abdominal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Guided Bilateral single shot Erector Spinae Plane BlockProcedure or surgery
Also called Ultrasound Guided erector spinae pkane block
Ultrasound Guided Erector Spinae Plane block given bilaterally at level of L1.
Caudal Block AnesthesiaProcedure or surgery
Ukltrasound Guided Caudal Epidural Block
| Study group | Role | What they receive |
|---|---|---|
| Caudal Block Group | Active comparator | Patients who received ultrasound guided Caudal Block Receives: Procedure: Caudal Block Anesthesia |
| Erector Spinae Plane Block Group | Active comparator | Patients who received ultrasound guided Erector Spinae Block Receives: Procedure: Ultrasound Guided Bilateral single shot Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 15 minutes and 30 minutes in PACU, then every 2 hours up to 8 hours after surgery.
Secondary outcomes (9)
Changes to heart rate (beats/minute)
Changes to heart rate (beats/minute) recorded before surgery, during surgery and immediately after surgery
Measured: 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
The time to first rescue analgesic.
Time from block administration to the patient's first requirement for rescue analgesia.
Measured: from 0 to 8 hours after block administration
Total postoperative analgesic requirements.
Amount and frequency of analgesia patient requested
Measured: 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.
Measured: At 8 hours after block administration
Number of patients required rescue analgesic postoperatively.
Number of patiebts of asked for rescue analgesia is recorded.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start1 May 2024
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Local Analgesia Via InfiltrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashraf A Abdelhalim, Doctorate, Study chair, Professor of Anesethia and Surgical Intensive Care.Ahmed M El Attar, Doctorate, Study director, Professor of Anesethia and Surgical Intensive Care.Aliaa R Abdel Aziz, Doctorate, Study director, Assistant Professor of Anesethia and Surgical Intensive Care.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281235
- Sponsor's protocol ID
- 9250511
- Status last verified
- Dec 2024
- First submitted
- 13 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31602352Aldrete 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.
PubMed 7772368Chanthong 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.
PubMed 19352161Lucente 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.
PubMed 35790215Forero 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.
PubMed 27501016Kollipara 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.
PubMed 34349375Chen 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.
PubMed 24722013Opfermann 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.
PubMed 35460068Kao 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.
PubMed 28337460Lamontagne 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.
PubMed 11481590Victoria 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.
PubMed 27525299Kain 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.
PubMed 16882820Gehdoo Rp. Post operative pain management in paediatric patients. IndianJ Anaesth 2004; 48(5):406-14.
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.
PubMed 23716315Birnie 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.
PubMed 30284240
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Analgesia With Ultrasound Guided Erector Spinae Block Versus Ultrasound Guided Caudal Block in Children
- ClinicalTrials.gov ID
- NCT07281235
- Acronym / sponsor ID
- 9250511
- Conditions
- Local Analgesia Via Infiltration, Caudal Epidural Anesthesia, Caudal Block, Caudal Block for Postoperative Analgesia, Caudal Anesthesia, Erector Spinae Plane Block
- Keywords
- Erector Spinae Block, Caudal Block, Pediatrics, llower abdominal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caudal Block Group | Active comparator | Procedure: Caudal Block AnesthesiaPatients who received ultrasound guided Caudal Block |
| Erector Spinae Plane Block Group | Active comparator | Procedure: Ultrasound Guided Bilateral single shot Erector Spinae Plane BlockPatients who received ultrasound guided Erector Spinae Block |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age between 2-7 years old.
- ASA I-II.
- Elective surgery under general anaesthesia.
- Lower abdominal surgery.
Key exclusion criteria (10 listed)
- Parent/caregiver refusal.
- Allergy to one of the study medications.
- Renal or cardiac disease.
- Infection or redness at the site of injection.
- Clinically significant coagulopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound Guided Bilateral single shot Erector Spinae Plane BlockAlso: Ultrasound Guided erector spinae pkane blockUltrasound Guided Erector Spinae Plane block given bilaterally at level of L1. | Procedure or surgery | Erector Spinae Plane Block Group |
| Caudal Block AnesthesiaUkltrasound Guided Caudal Epidural Block | Procedure or surgery | Caudal Block Group |
Primary outcome
Compare the efficacy of postoperative pain management of Erector Spinae Block versus Caudal Block.
Time frame: At 15 minutes and 30 minutes in PACU, then every 2 hours up to 8 hours after surgery.
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.
9 secondary outcomes
Changes to heart rate (beats/minute)
Time frame: 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
The time to first rescue analgesic.
Time frame: from 0 to 8 hours after block administration
Total postoperative analgesic requirements.
Time frame: from 0 to 8 hours after block administration
Parent satisfaction with a 5-point Likert scale questionnaire.
Time frame: At 8 hours after block administration
Number of patients required rescue analgesic postoperatively.
Time frame: From 0 to 8 hours after surgery.
Time to Modified Aldrete score ≥9.
Time frame: from arrival to PACU (0 hours) until achieving an Aldrete score ≥9 (expected within 60 minutes)
Incidence of any adverse effects.
Time frame: from end of surgery (0 hours) to 8 hours postoperatively
Changes to mean arterial pressure (MAP)
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Background: PubMed 31602352Aksu 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.
- Background: PubMed 7772368Aldrete 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.
- Background: PubMed 19352161Chanthong 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.
- Background: PubMed 35790215Lucente 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.
- Background: PubMed 27501016Forero 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.
- Background: PubMed 34349375Kollipara 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.
- Background: PubMed 24722013Chen 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.
- Background: PubMed 35460068Opfermann 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.
- Background: PubMed 28337460Kao 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.
- Background: PubMed 11481590Lamontagne 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.
- Background: PubMed 27525299Victoria 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.
- Background: PubMed 16882820Kain 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashraf A Abdelhalim, Doctorate study chair
Professor of Anesethia and Surgical Intensive Care.
Ahmed M El Attar, Doctorate study director
Professor of Anesethia and Surgical Intensive Care.
Aliaa R Abdel Aziz, Doctorate study director
Assistant Professor of Anesethia and Surgical Intensive Care.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Guided Bilateral single shot Erector Spinae Plane Block and Caudal Block Anesthesia in people with Local Analgesia Via Infiltration and Caudal Epidural Anesthesia, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the efficacy of postoperative pain management of Erector Spinae Block versus Caudal Block. (time frame: At 15 minutes and 30 minutes in PACU, then every 2 hours up to 8 hours after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07281235, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.