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CTRI Number  CTRI/2025/05/086112 [Registered on: 01/05/2025] Trial Registered Prospectively
Last Modified On: 30/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Patients undergoing lumbar spine surgeries will be divided into to groups, one group will receive USG guided erector spinae plane block just before surgery and other group will not receive any block to check the efficacy of erector spinae block by comparing total fentanyl consumption at 24 hour. 
Scientific Title of Study   The efficacy of erector spinae plane block for post-operative analgesia in patients undergoing lumbar spine surgery: A prospective randomized controlled trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amit kumar 
Designation  Junior Resident 
Affiliation  Rajendra Institute of Medical Sciences, Bariatu, Ranchi 
Address  Department of Anesthesiology, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand 834009 India

Ranchi
JHARKHAND
834009
India 
Phone  9934388657  
Fax    
Email  akdhoni7658927@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ekramul Haque 
Designation  Associate Professor 
Affiliation  Rajendra Institute of Medical Sciences, Bariatu, Ranchi 
Address  Department of Anesthesiology, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand 834009 India

Ranchi
JHARKHAND
834009
India 
Phone  9431101186  
Fax    
Email  ekramrims@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Saurabh Suman 
Designation  Assistant Professor 
Affiliation  Rajendra Institute of Medical Sciences, Bariatu, Ranchi 
Address  Department of Anesthesiology, Rajendra Institute of Medical Sciences, Bariatu, Ranchi, Jharkhand 834009 India

Ranchi
JHARKHAND
834009
India 
Phone  7079893536  
Fax    
Email  saurabh31.7.dmch@gmail.com  
 
Source of Monetary or Material Support  
Rajendra institute if medical sciences, Bariatu, Ranchi, Jharkhand, 834009. 
 
Primary Sponsor  
Name  Rajendra Institute Of Medical Sciences 
Address  Department Of Anesthesiology, Rajendra Institute of Medical Sciences, Ranchi, Jharkhand. PIN- 834009 
Type of Sponsor  Government 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 Amit kumar  Rajendra institute of medical sciences, Ranchi.  Department of anesthesiology, neurosurgery, orthopedics Rajendra Institute of Medical Sciences Ranchi, JHARKHAND 834009 INDIA
Ranchi
JHARKHAND 		 09934388657

akdhoni7658927@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, RIMS, RANCHI  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparison group will receive genrat anesthesia without any nerve block  this group will undergo standard general anesthesia without any block. They will also be monitored for pain using VAS scale for 24 hour post operatively. 
Intervention  Ultrasound guided rector spinae plane block.  Intervention group will undergo standard general anesthesia first , then with the help of ultrasound erector spinae block will be given bilaterally at the level of spine with 0.5% ropivacaine 20ml (10 ml on each side).This will take almost 5-10 minutes. then the patient will be handover to the surgeon for the surgery. After the surgery is over and patient gets extubated after proper reversal, pain will be monitored using VAS (visual analogue scale) for 24 hour.. If the VAS score will be 3 bolus of inj. fentanyl 2mcg/kg will be given.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA Grade -I/II
BMI 18-35kg/m2
 
 
ExclusionCriteria 
Details  ASA Grade - III/IV
Patient with coagulopathies
Psychological illness.
 
 
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 
To compare the total opioid (fentanyl) consumption at 24 hr post operatively in patients receiving the ultrasound guided erector spinae block to the control group who will not receive the block.  Total fentanyl consumption 24 hour post operatively. 
 
Secondary Outcome  
Outcome  TimePoints 
a)Pain scores at rest and movement.

b)Patient satisfaction score.

c)time to the first bolus of fentanyl requirement.

d)hemodynamic changes 		 Patient satisfaction score
1-very dissatisfied
2-dissatisfied
3-satisfied
4-very satisfied

HR, RR, NIBP will be measured
1 hour post surgery
3 hours post surgery
6 hours post surgery
12 hours post surgery
24 hours post surgery 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/05/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   Spine surgeries demand extensive surgical dissection of ligaments, bones, and subcutaneous tissues, thus resulting in appreciable post-operative pain. Inadequate analgesia may lead to poor post recovery, delayed ambulation, poor surgical outcomes and increased lengths of hospital stay. Earlies pain was managed by opioids but evidence suggests that pain control was inadequate and higher doses  had adverse effects such as sedation, respiratory depression, nausea, vomiting, ileus, impaired cognition etc.
Simplified sonoanatomy without risk of needle puncture to any vital structures in immediate vicinity makes erector spinae plane block a safe and productive analgesic technique.
 
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