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

Phase 4

Not yet recruiting

• Conditions: Other Procedures,

• Registration Number: CTRI/2025/04/084203
• Lead Sponsor: Dr Zainab Ahmed

Brief Summary

Regional anesthesia is now recommended as an adjunct to general anesthesia whenever feasible for its opioid and anesthetic sparing effect. Caudal epidural block (CEB) is one of the most routinely practiced regional anesthetic procedures for intra and post-operative analgesia in paediatric patients. Although complications are rare, adverse effects reported include intravascular, subarachnoid or intraosseous space injection, hypotension (more common in adults), epidural hematoma as well as urinary retention.  USG-guided ESPB is now a common regional anesthetic technique used in clinical practice for a variety of indications including breast reconstruction surgeries, lumbar spine fusion surgeries, post thoracotomy surgeries and hemorrhoidectomy surgeries. In paediatric patients it has shown effective pain control in hypospadias surgery, lower abdominal surgeries, hip surgeries and spine surgeries. It is considered a very safe block and very few adverse effects have been reported till date because the target area that is the vertebral transverse process is an avascular space and is away from all major vital structures and the neuraxis. The various approaches to the ESPB include thoracic, lumbar and sacral depending on the level of the target dermatomes. Sacral ESPB blocks lumbo-sacral dermatomes and is useful for lower abdominal and lower limb surgeries.

On extensive literature review, we could not find any study directly comparing sacral ESPB and caudal epidural block in pediatric patients undergoing lower limb surgery. Therefore, this study to compare sacral ESPB with caudal epidural block has been planned.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-04-04
• Study Start: 2025-04-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 54

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	T0 0 hour | T1 1 hour | T2 2 hours | T3 6 hours | T4 12 hours | T5 24 hours

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

AIIMS Bhopal; 🇮🇳 Bhopal, MADHYA PRADESH, India

AIIMS Bhopal

🇮🇳Bhopal, MADHYA PRADESH, India

Dr Nishant Varlani

Principal investigator

07793066644

nsvarlani@gmail.com