Comparison of efficacy in pain relief ,changes in pulse rate, blood pressure and surgeon’s satisfaction between landmark guided, C-Arm guided And USG guided erector spinae block in lumbar spine surgery

Phase 2/3

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2025/03/083314
• Lead Sponsor: R. G. KAR MEDICAL COLLEGE AND HOSPITAL

Brief Summary

After getting clearance from the said ethics committeethis study will be conducted in the neurosurgery operation theatre of R.G KarMedical College & Hospital  in theperiod from 2022 to 2023. After careful consideration of inclusion andexclusion criteria the patients posted for lumbar spine fixation surgery willbe enrolled in the study. Patients will be divided into three equal groups [landmarkguided erector spinae block vs C-ARM guided erector spinae block vs USG guidederector spinae block] by computer-generated randomization method. Every group will receive bilateral erector spinae block using  0.25 % Bupivacaine followed by general anaesthesia. Duration of analgesia  in terms of VAS , total analgesic requirementin  first 24 hours ,Intraoperativesurgeons’ satisfaction in terms 0f 5-point Likert scale, intraoperative blood loss using Boezzart’sscale,  hemodynamic changes  by measuring mean arterial pressure (MAP) andpulse rate  and other side effects like  post operative nausea , vomiting , patients’discomfort  will  be assessed and compared between these threegroups.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-03-24
• Study Start: 2025-10-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Posted for lumbar spine fixation surgeries 2.
• 2 or 3 level lower lumbar spine (L3-L4/L4-L5) surgery by posterior approach 3.
• ASA Grade 1 and 2 patients 4.
• Age between 18-60 years of either sex 5.
• Patients with BMI between20-30.

Exclusion Criteria

• Uncooperative patients or refusal.
• ASA Grade 3 or above 3.
• Duration of surgery more than 2 hours 4.
• Uncontrolled Diabetes and Hypertension.
• Chronic Obstructive Pulmonary Disease and Bronchial Asthma.
• Bleeding disorder 8.
• On psychiatric medication.
• Known allergy to the drug used.
• Any kind of preexisting neuropathy.
• Alcoholism.
• Chronic opioid use (Defined as daily and almost daily use of opioids for more than 3 months).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the duration of post-operative analgesia.(timing of first rescue analgesic)	JUNE 2023 TO JUNE 2024
2) Grade of sensory block through touch and pin prick method.	JUNE 2023 TO JUNE 2024
3) Motor function of leg will be evaluated with a Bromage (0-3) score.	JUNE 2023 TO JUNE 2024

Secondary Outcome Measures

Name	Time	Method
i)Intraoperative haemodynamics with respect to changes in HR and MAP.	ii)Intraoperative bleeding using Boezzart’s scale

Trial Locations

Locations (1)

R. G. KAR MEDICAL COLLEGE AND HOSPITAL; 🇮🇳 Kolkata, WEST BENGAL, India

R. G. KAR MEDICAL COLLEGE AND HOSPITAL

🇮🇳Kolkata, WEST BENGAL, India

SONALINA MUDI

Principal investigator

9051283086

sonalina.mudi701@gmail.com