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Comparison of efficacy in pain relief ,change in pulse rate, blood pressure and surgeons’ satisfaction between general anaesthesia with local anaesthetic in between lumbar vertebra and erector spine muscle and local anaesthetic injected in spinal space in lumbar spine surgery

Comparison of perioperative analgesic efficacy , haemodynamics and surgeons’ satisfaction between general anaesthesia with erector spinae plane block along with spinal anaesthesia in lumbar spine surgery

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/055014
Enrollment
80
Registered
2023-07-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Erector spinae plane block with Bupivacaine and Fentanyl: A single administration of 20 ml study drug preparation [bupivacaine (0.25%) 19 ml + fentanyl 1 ml (50 mcg) ] into the targe

Sponsors

R. G. KAR MEDICAL COLLEGE AND HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Posted for one or two level lumbar discectomy/laminectomy ( L3 , L4 , L5) 2. ASA Grade 1 and 2 patients 3. Age between 18-60 years of either sex 4. Patients with BMI between 20-30

Exclusion criteria

Exclusion criteria: 1.Uncooperative patients or refusal. 2. ASA Grade 3 or above 3. Duration of surgery more than 2 hours 4. Cardiac and neurological diseases. 5. Uncontrolled Diabetes and Hypertension. 6. Chronic Obstructive Pulmonary Disease and Bronchial Asthma. 7. Bleeding disorder 8. On psychiatric medication. 9. Known allergy to the drug used. 10. Epilepsy. 11. Any kind of preexisting neuropathy. 12. Alcoholism. 13. Chronic opioid use (Defined as daily and almost daily use of opioids for more than 3 months).

Design outcomes

Primary

MeasureTime frame
1)Duration of analgesia in both groups in terms of VAS score 2)Total analgesic requirement in first 24 hours in both group Timepoint: duration of analgesia is defined as time interval between complete sensory block and time of first rescue analgesia

Secondary

MeasureTime frame
Intraoperative surgeons satisfaction in terms of 5point Likert scaleTimepoint: It will be assessed immediately after completion of operation , preferably after 2 hours from start of operation

Countries

India

Contacts

Public ContactMD AZIZ BILLAHA

R. G. KAR MEDICAL COLLEGE AND HOSPITAL

saikatneuro1972@gmail.com9831732443

Outcome results

None listed

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