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A pilot study comparing a nerve block (ESPB) and Fentanyl for treating patients with severe back pain in the Emergency Department.

Efficacy of the Erector Spinae Plane Block (ESPB) versus Fentanyl for alleviating pain in patients with acute severe backache in the Emergency Department: a comparative parallel-group two-arm open label pilot randomized control trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092617
Enrollment
60
Registered
2025-08-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: M545- Low back pain

Interventions

Intervention1: Erector Spinae Plane Block (ESPB): The patient will be positioned in their comfortable posture (sitting, recumbent, lateral rotation). The site for block will depend upon patient s pres

Sponsors

All India Institute of Medical Sciences, New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older 2. Acute severe lumbar back pain 3. DVPRS score of 7 or more

Exclusion criteria

Exclusion criteria: 1. Symptoms of cauda equina syndrome 2. Progressive neurologic symptoms 3. Abdominal Aorta Aneurysm 4. Vertebral fracture 5. Evidence of skin/soft tissue infection at the block site 6. Spine deformity (both acquired or congenital) 7. Known Bleeding Disorder 8. Unwillingness to participate 9. Allergy to any of the research medications 10. Pregnancy 11. Patients of Chronic liver disease, Chronic kidney Disease, Congestive heart failure 12. Immunocompromised patients 13. Hemodynamically unstable patients

Design outcomes

Primary

MeasureTime frame
To assess the efficacy of successful pain relief after six hours of intervention in both ESPB arm and Fentanyl armTimepoint: 30 minutes, 1 hour, 2 hours, 6 hours—

Secondary

MeasureTime frame
To study safety of ESPB in comparison to Fentanyl at 6 hoursTimepoint: 6 hours;To evaluate patient satisfaction among patient groups receiving ESPB versus Fentanyl in terms of reduction of pain in Likert scale (from 0: Very unsatisfied to 5: very satisfied )Timepoint: 6 hours;To assess the amount of rescue analgesic medications required at 6 hours of interventionTimepoint: 6 hours—

Countries

India

Contacts

Public ContactDr Sanjeev Bhoi

All India Institute of Medical Sciences, New Delhi

sanjeevbhoi@gmail.com8527050391

Outcome results

None listed

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