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A Study Comparing Different Doses of A Drug Named Dexmedetomidine in Erector Spinae Plane Block for Improving Pain Relief in Adult Patients Undergoing Lumbar Spine Surgery

Comparative Evaluation of Effectiveness of Different Doses of Dexmedetomidine as an Adjunct in Erector Spinae Plane Block in Adults Undergoing Lumbar Spine Surgery - ESP-DEX TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/098337
Enrollment
230
Registered
2025-12-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: M511- Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy

Interventions

Intervention1: Dexmedetomidine @ 0.5 g/kg body weight: Patients will receive ultrasound guided ESP block using 40ml 0.25% Levobupivacaine plus Dexmedetomidine @ 0.5 g/kg body weight, after induction

Sponsors

Dr Pooja Chapegadikar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 230 patients of the American Society of Anaesthesiologists (ASA) physical status I/II aged between 18 and 75 years and of either sex with a body mass index (BMI) of 18-35 kg/m2 scheduled to undergo lumbar spine surgery requiring laminectomy or laminotomy and pedicle screw rod fixation for decompression (up to 4 levels) will be included in this study.

Exclusion criteria

Exclusion criteria: Psychiatry patients, patient refusal to participate in study, patient on beta blockers, baseline heart rate less than 60 beats per min or cardiac conduction block or other significant cardiopulmonary disease, central neuropathy, body mass index more than 35kg/m2, local infection at injection site, history of hypersensitivity to local anaesthetics or dexmedetomidine

Design outcomes

Primary

MeasureTime frame
To study the effectiveness of two different doses of Dexmedetomidine by a) comparing time of first request for rescue analgesia in both the groups, b) comparing Numerical Rating Scale (NRS) score in both the groups c) comparing total fentanyl consumption in both the groups Timepoint: a) Inter-group comparison of time of first request for rescue analgesia in postoperative period, b) Inter-group comparison of Numerical Rating Scale (NRS) score at at 2, 4, 6, 12, and 24 hours in the postoperative period, c) Inter-group comparison of total fentanyl consumption during intraoperative period and 24hours postoperative period—

Secondary

MeasureTime frame
Compare intra-operative blood pressure & heart rate after administration of ESP blockTimepoint: Baseline; at 15minutes, 30minutes, 45minutes, 1hour after administration of Erector Spinae Plane Block; then subsequently at hourly intervals until the end of surgery—

Countries

India

Contacts

Public ContactDr Pooja Chapegadikar

MAX SUPERSPECIALITY HOSPITAL, SAKET, NEW DELHI

drpoojachapegadikar87@gmail.com7224883945

Outcome results

None listed

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