Comparative Analysis of Ultrasound-Guided Sacral Erector Spinae Plane Block and Caudal Epidural Block for pain relief Efficacy in Pediatric Lower Limb Surgery

Comparison of the analgesic efficacy of ultrasound guided Sacral Erector Spinae Plane Block with ultrasound guided Caudal epidural Block in paediatric patients undergoing lower limb surgery under general anaesthesia: a randomised controlled study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084203

Enrollment

Registered

2025-04-07

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: 8- Other Procedures

Interventions

Intervention1: Sacral Erector Spinae Plane Block: After inducing the patient under general anesthesia, before the incision, local anesthetic will be injected in sacral erector spinae plane in a dose 1

Eligibility

Inclusion criteria

Inclusion criteria: The study will include all paediatric patients of age 1 years - 9 years, of either sex, ASA(American Society of Anesthesiologists classification of Physical Status) grade I and II undergoing elective or emergency lower limb surgery whose plan of anesthesia is decided as general anesthesia with a regional anesthesia technique.

Exclusion criteria

Exclusion criteria: 1.Contraindications to regional technique e.g. allergy to local anesthetic drugs, local site infection, sepsis, coagulation disturbance, anatomical abnormalities etc 2.Infants ( because of challenging blocks in this age group). 3.More than 9 years of age (due to the anatomical difficulties expected during caudal epidural block because of progressive ossification of sacrococcygeal ligament making the identification of the sacral hiatus difficult.) 4.Patient with neurological disorders 5.Patient with cutaneous anomalies (angioma, hair tuft, naevus , dimple at the site of block) 6.Inability to identify landmarks. 7.Patients on anti-epileptic drugs or any other enzyme inducers as that would affect the metabolism of the drug. 8.Hypersensitivity/contra-indication to any of the study drugs- local anesthetic or analgesic 9.Patients with polytrauma and patients with fractures of both upper and lower limb.

Design outcomes

Primary

Measure	Time frame
Duration of post-operative analgesia is defined as the time after surgery within the first 24 hours at which Face, Leg, Activity, Cry and Consolability score (FLACC score) (a validated pain score) more than 4 or a verbal request of analgesics from verbal children.Timepoint: T0 0 hour T1 1 hour T2 2 hours T3 6 hours T4 12 hours T5 24 hours	—

Secondary

Measure	Time frame
1.To assess & compare intraoperative opioid requirement in both the groups defined as total number of doses of fentanyl required. 2.To determine & compare the number & cumulative doses of rescue analgesics in the first 24 hours postoperatively. 3.To determine the fraction of patients requiring rescue analgesics within the first 24 hours postoperatively. 4.To determine Parental Satisfaction Score in both groups at postoperative day 1 (POD1).Timepoint: 0 hour, 1hour, 2hours, 6hours, 24 hours	—

Measure

Time frame

1.To assess & compare intraoperative opioid requirement in both the groups defined as total number of doses of fentanyl required. 2.To determine & compare the number & cumulative doses of rescue analgesics in the first 24 hours postoperatively. 3.To determine the fraction of patients requiring rescue analgesics within the first 24 hours postoperatively. 4.To determine Parental Satisfaction Score in both groups at postoperative day 1 (POD1).Timepoint: 0 hour, 1hour, 2hours, 6hours, 24 hours

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Countries

India

Contacts

Public ContactDr Zainab Ahmed

AIIMS Bhopal

drzainabhaq@gmail.com8860048951

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026