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CTRI Number  CTRI/2023/06/054101 [Registered on: 19/06/2023] Trial Registered Prospectively
Last Modified On: 26/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Post surgery pain relief following lumbar spine surgeries 
Scientific Title of Study   Comparative evaluation of ultrasound guided bilateral erector spinae block and ultrasound guided caudal block in lumbar spine surgeries for postoperative analgesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SANGIREDDY KAVYASREE 
Designation  POST GRADUATE 
Affiliation  SRI SIDDHARTHA MEDICAL COLLEGE, TUMKUR 
Address  POSTGRADUATE,DEPARTMENT OF ANAESTHESIOLOGY,SRI SIDDHARTHA MEDICAL COLLEGE AND RESEARCH INSTITUTE,TUMKUR,KARNATAKA

Tumkur
KARNATAKA
572107
India 
Phone  8309961495  
Fax    
Email  kavyareddysangireddy@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR PRAKASH B C 
Designation  PROFESSOR 
Affiliation  SRI SIDDHARTHA MEDICAL COLLEGE, TUMKUR 
Address  DEPARTMENT OF ANAESTHESIOLOGY, SRI SIDDHARTHA MEDICAL COLLEGE AND RESEARCH INSTITUTE, TUMKUR,KARNATAKA

Tumkur
KARNATAKA
572107
India 
Phone  9480542245  
Fax    
Email  drprakashbc@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR PRAKASH B C 
Designation  PROFESSOR 
Affiliation  SRI SIDDHARTHA MEDICAL COLLEGE, TUMKUR 
Address  DEPARTMENT OF ANAESTHESIOLOGY, SRI SIDDHARTHA MEDICAL COLLEGE AND RESEARCH INSTITUTE, TUMKUR,KARNATAKA

Tumkur
KARNATAKA
572107
India 
Phone  9480542245  
Fax    
Email  drprakashbc@gmail.com  
 
Source of Monetary or Material Support  
SRI SIDDHARTHA MEDICAL COLLEGE AND HOSPITAL ,TUMKUR 
 
Primary Sponsor  
Name  SRI SIDDHARTHA MEDICAL COLLEGE AND HOSPITAL, TUMKUR 
Address  DEPARTMENT OF ANAESTHESIOLOGY, SRI SIDDHARTHA MEDICAL COLLEGE AND HOSPITAL, TUMKUR - 527107 KARNATAKA  
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 SANGIREDDY KAVYA SREE  SRI SIDDHARTHA MEDICAL COLLEGE AND HOSPITAL  DEPARTMENT OF ANAESTHESIA DRI SIDDHARTHA MEDICAL COLLEGE AND HOSPITAL TUMKUR 572107
Tumkur
KARNATAKA 		 8309961495

kavyareddysangireddy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
THE INSTITUTIONAL ETHICS COMMITTEE  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  ULTRASOUND GUIDED BILATERAL ERRECTOR SPINAE BLOCK WITH INJ ROPIVACAINE 0.25% 20ML EACH SIDE (ONE TIME)duration 15 mins and 100mg   COMPARITIVE EVALUATION OF ULTRASOUND GUIDED BILATERAL ERECTOR SPINAE BLOCK AND ULTRASOUND GUIDEDCAUDAL BLOCK IN LUMBAR SPINE SURGERIES FOR POST OPERATIVE ANALGESIA 
Intervention  ULTRASOUND GUIDED CAUDAL BLOCK WITH INJ ECTION ROPIVACAINE 0.25% 20ML ONETIME duration 15 mins and dosage 100 mg  COMPARITIVE EVALUATION OF ULTRASOUND GUIDED BILATERAL ERECTOR SPINAE BLOCK AND ULTRASOUND GUIDEDCAUDAL BLOCK IN LUMBAR SPINE SURGERIES FOR POST OPERATIVE ANALGESIA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Patients belonging to ASA class I, II
2) Patients undergoing lumbar spine (L1-L5) surgeries under General Anaesthesia.
3)BMI < 29.9 kg/m2
4) Patient who has given valid informed consent  
 
ExclusionCriteria 
Details  1)Patient’s refusal.
2) Bleeding disorders (platelets count <1,50,000; international normalized ratio >1.5;PC<60%) and coagulopathies.
3) Skin lesions, wounds or infection at the injections site.
4) Known allergy to local anesthetic drugs.
5) Chronic opioid or NSAIDS users.
6) Patients with pre-operative opioid consumption. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Time to first analgesia request  immediately, 30 mins, 1 hour, 2, 6 and 12 hour after injection.  
 
Secondary Outcome  
Outcome  TimePoints 
- Presence of any complications immediately
- Presence of any complications such as urine retention, vomiting ,
respiratory depression.
- Mean arterial blood pressure [ Time Frame: every 5 minutes intraoperative till end of surgery (up to 2 hours) ]intraoperative mean arterial blood pressure.
- Heart rate [ Time Frame: every 5 minutes intraoperative till end of surgery(up to 2 hours) ] intraoperative heart rate.
- VAS score [ Time Frame: at 30 mins, then at 1, 2, 6, 12, 24 hours post-operatively ]The visual analog score(VAS) is a validated, subjective measure for acute and chronic pain. scores are recorded by making a handwritten mark on a 10 cm line that represents a continuum between "no pain" and "worst pain".
 		 1,2,6,12,24 hrs after injection 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   27/06/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 A hospital based  comparative evaluaton of ultrasound guided bilateral erector spinae block and ultrasound guided caudal block in lumbar spinae surgeries for post operative analgesia .
  
INTRODUCTION: 
pain : it is unpleasant sensation that can be very severe requiring large doses of opiods resulting in respiratory depression ,vomiting and pruritis .
 
so,regional anaesthesia techniques for postoperative analgesia overcomes these complication of opiods. Erector spinae block and caudal block will be evaluated in study for post operative analgesia.

ASA1&2 patients aged 18to 65 years posted for lumbar spine surgeries (L1-L5) at sri siddartha medical college and research centre ,tumkur will be selected for the study period of 24 months with sample size 40 patients .

All patients as per inclusion and exclusion criteria posted for elective orthopaedic surgical procedures will be taken in the study .

Methodology : the data is collected by convenient sampling .the data will be entered in excel spread sheet .Descriptive 

statistical analysis will be carried out .Quantitive variables will be  presented as frequency and percentages .The associaton between categorical variables will be analysed by applying chi square test .The data will be analysed by using SPSS software (version 20)
 
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