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CTRI Number  CTRI/2025/03/083676 [Registered on: 28/03/2025] Trial Registered Prospectively
Last Modified On: 25/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Two Pain Relief Methods After Spine Surgery: ESP Block vs. Local Injections 
Scientific Title of Study   Postoperative Analgesic Efficacy of Ultrasound-Guided Erector Spinae Plane Block versus Local Infiltration Analgesia in Patients Undergoing Lumbar Spine Fixation under General Anaesthesia: A Randomised Double BlindTrial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rakesh Saxena 
Designation  Co-Chairperson and Senior Consultant 
Affiliation  Sir Gangaram Hospital, Delhi  
Address  Institute of Anaesthesiology, Pain and Perioperative Medicine, Sir Gangaram Hospital, Delhi

Central
DELHI
110060
India 
Phone  9810373301  
Fax    
Email  Rakeshsaxena3009@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Siddharth Goyal 
Designation  DNB Trainee Post Diploma 
Affiliation  Sir Gangaram Hospital, Delhi  
Address  Institute of Anaesthesiology, Pain and Perioperative Medicine, Sir Gangaram Hospital, Delhi

Central
DELHI
110060
India 
Phone  8076128103  
Fax    
Email  Dr.siddharth.goyal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Siddharth Goyal 
Designation  DNB Trainee Post Diploma 
Affiliation  Sir Gangaram Hospital, Delhi  
Address  Institute of Anaesthesiology, Pain and Perioperative Medicine, Sir Gangaram Hospital, Delhi

Central
DELHI
110060
India 
Phone  8076128103  
Fax    
Email  Dr.siddharth.goyal@gmail.com  
 
Source of Monetary or Material Support  
Institute of Anaesthesiology, Pain & Perioperative Medicine, 5th Floor, Sir Gangaram Hospital, Old Rajinder Nagar, New Delhi-110060 
 
Primary Sponsor  
Name  Sir Ganga Ram Hospital 
Address  Institute of Anaesthesiology, Pain and Perioperative Medicine, 5th Floor,SGRH, Delhi-110060 
Type of Sponsor  Research institution and hospital 
 
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 Rakesh Saxena  Sir Ganga Ram Hospital  5TH FLOOR, SSRB Block, Sir Ganga Ram Hospital, Rajinder Nagar, Delhi-110060
Central
DELHI 		 9810373301

rakeshsaxena3009@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Sir Ganga Ram Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Erector Spinae Plane(ESP) Block Group  The patient will receive a USG-guided bilateral ESP block with 15 ml of 0.25% levo-bupivacaine on each side intraoperatively. 
Comparator Agent  Incision Site Infiltration of Local Anaesthesia (LIA)  The patient will receive peri incisional infiltration analgesia with 30 ml of 0.25% levo-bupivacaine intraoperatively. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 or 2 level spine fixation surgeries
Body mass index (BMI) - 18-30 kg/m2
American Society of Anaesthesiology (ASA) Grade - I & II 
 
ExclusionCriteria 
Details  Refusal of consent to participate in study
More than 2 level of spine fixation surgery
Coagulation disorders(INR more than 1.5)
History of hypersensitivity to local or systemic anaesthetic agents
Block Failure 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
First rescue analgesia  in postoperative period within 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic parameters, Postoperative pain scores, Functional recovery,
Patient satisfaction & PONV 		 At 0.5, 1, 2, 6, 12, 24
hours post surgery 
 
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   N/A 
Date of First Enrollment (India)   18/04/2025 
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="9"
Days="0" 
Recruitment Status of Trial (Global)   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   This randomized, double-blind, parallel-group, single-center trial compares the efficacy of ultrasound-guided erector spinae plane (ESP) block to local infiltration analgesia (LIA) with 0.25% Levobupivacaine in patients undergoing lumbar spine fixation surgery under general anesthesia. The primary outcome is the time to first rescue analgesia post-surgery. Secondary outcomes include hemodynamic parameters (mean arterial pressure and heart rate) at various intervals up to 24 hours post-surgery, postoperative pain scores using the Numerical Rating Scale (NRS), functional recovery (time to first ambulation and self-voiding), patient satisfaction for pain relief using a 5-point Likert scale, and postoperative nausea and vomiting (PONV) scores at 0.5, 1, 2, 6, 12, and 24 hours post-surgery. 
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