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CTRI Number  CTRI/2025/11/097602 [Registered on: 18/11/2025] Trial Registered Prospectively
Last Modified On: 09/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of spinal anesthesia with a plane block for analgesia in lower back surgeries. 
Scientific Title of Study   Comparison of spinal anaesthesia with erector spinae block for analgesia in lumbar spine surgeries - a prospective randomized clinical trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhavna sriramka 
Designation  professor 
Affiliation  IMS and sum hospital 
Address  anesthesia department ims and sum hospital bhubaneswar

Khordha
ORISSA
751019
India 
Phone  9406033609  
Fax    
Email  bhavna.sriramka@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Bhavna sriramka 
Designation  professor 
Affiliation  IMS and sum hospital 
Address  anesthesia department ims and sum hospital bhubaneswar


ORISSA
751019
India 
Phone  9406033609  
Fax    
Email  bhavna.sriramka@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Bhavna sriramka 
Designation  professor 
Affiliation  IMS and sum hospital 
Address  anesthesia department ims and sum hospital bhubaneswar


ORISSA
751019
India 
Phone  9406033609  
Fax    
Email  bhavna.sriramka@gmail.com  
 
Source of Monetary or Material Support  
IMS and SUM Hospital bhubaneswar, ODISHA,India 751003 
 
Primary Sponsor  
Name  IMS and SUM hospital 
Address  Anesthesia department First floor Bhubaneswar 751003 Khordha ORISSA 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bhavna sriramka  IMS and SUM Hospital  NEUROSURGERY OPERATION THEATRE,First floor,IMS and sum hospital Bhubaneswar 751003 Khordha
Khordha
ORISSA 
9406033609

bhavna.sriramka@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional ethics Commitee, IMS and SUM Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, (2) ICD-10 Condition: M489||Spondylopathy, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  erector spinae block   before GA patient will receive erector spinae block at L2 level Ropivacaine (0.2%) 20 ml and Dexmedetomidine 0.25mcg/kg both sides.  
Intervention  thoracic segmental spinal  Before GA, the Patient will receive segmental spinal at L1 - L2 isobaric ropivacaine (0.2%) 1.5 ml and dexmedetomidine 5 mcg. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Lumbar Surgeries like lumbar discectomy, laminectomy, spinal fusion, or other lumbar spine surgeries, ASA grade (1,2), informed consent  
 
ExclusionCriteria 
Details  cardiovascular diseases, ASA 3 or more then 3
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Compare postoperative pain scores (NRS) after 30 minutes of extubation.
Total analgesic requirement that is number of rescue analgesic doses in 24 hours (tramadol 2 mg/kg) between the two groups
 
30 minutes, 24 hours
 
 
Secondary Outcome  
Outcome  TimePoints 
Time to first analgesic request postoperatively.
Haemodynamic monitoring intra-operatively (HR and MBP )
Evaluate the incidence of intraoperative and postoperative complications, 
baseline, after, Before incision, after skin incision, 15 min, 30 min, 45 min, at the end of extubation.
 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

A significant proportion of people suffer from degenerative disc disease and lumbar disc herniation.The introduction of ultrasound technology into peripheral blocks increased the popularity of plane blocks, particularly the erector spinae plane block (ESPB).

Erector spinae plane block (ESPB) is a regional anaesthetic technique in which local anaesthetic spread along the dorsal rami, making this technique specifically appealing for spine surgery. ESPB is usually used for postoperative rescue strategy for pain. 

Spinal anesthesia is a feasible, safe and economical anesthesia technique for various abdominal and thoracic surgeries. It is also associated with less postoperative complications and patient satisfaction. spinal anesthesia for surgical analgesia in these procedures has been established as an accepted technique for many years. Anesthesia levels for lumbar surgery can be easily achieved with hyperbaric or isobaric local  anaesthetics. Some of the benefits of performing spinal anesthesia for lumbar surgery include a perceived  decrease in blood loss, lower rates of thromboembolism, less hypertension or tachycardia, and  better postoperative pain control. 

However, most commonly GA is the more preferred technique. This preference may be due to the greater acceptance by patients, the ability to perform longer operations or the anesthesiologist feeling more comfortable seeing that the airway is secured before placing the patient in the prone position.

We aim to compare the postoperative pain score with  spinal anesthesia in addition to GA with ESPB in patients undergoing lumbar surgeries.

 
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