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CTRI Number  CTRI/2022/09/045813 [Registered on: 23/09/2022] Trial Registered Prospectively
Last Modified On: 07/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study on dexmethasone as an adjuvant to 0.2% Ropivacaine in USG guided preemptive caudal epidural block for peri operative analgesia in patients undergoing lumbar spine surgeries  
Scientific Title of Study   A Comparative study on Dexamethasone as an adjuvant to 0.2% Ropivacaine in USG Guided Pre-Emptive Caudal Epidural block for perioperative analgesia in patients undergoing degenerative lumbar spine surgeries  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Swati Bisht 
Designation  Professor Anesthesia  
Affiliation  Vydehi institute of medical sciences and research centre 
Address  Vydehi medical college, Whitefield, Bengaluru- 560066

Bangalore
KARNATAKA
560066
India 
Phone  9880463983  
Fax    
Email  swatibisht1199@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sitara A Y 
Designation  PG Anesthesia  
Affiliation  Vydehi institute of medical sciences and research centre 
Address  Vydehi medical college, Whitefield, Bengaluru

Bangalore
KARNATAKA
560066
India 
Phone  9902096666  
Fax    
Email  drsitaraay@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sitara A Y 
Designation  PG Anesthesia  
Affiliation  Vydehi institute of medical sciences and research centre 
Address  Vydehi medical college, Whitefield, Bengaluru

Bangalore
KARNATAKA
560066
India 
Phone  9902096666  
Fax    
Email  drsitaraay@gmail.com  
 
Source of Monetary or Material Support  
Vydehi institute of medical sciences and research centre  
 
Primary Sponsor  
Name  Dr Sitara A Y 
Address  Vydehi medical college, Whitefield, Bengaluru. 
Type of Sponsor  Other [SELF] 
 
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 Sitara  Vydehi institute of medical sciences and research centre   Department of anaesthesiology First floor Nallurhalli main road, near BMTC 18th Depot, Vijayanagar, Whitefield. Bengaluru 560066
Bangalore
KARNATAKA 		 9902096666

drsitaraay@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vydehi institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 3||Administration, (2) ICD-10 Condition: 3||Administration, (3) ICD-10 Condition: 3||Administration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Caudal epidural block in patients undergoing degenerative lumbar spine surgeries   Inj Ropivacaine 0.2% with Inj Dexamethasone 8mg used for caudal epidural block 
Intervention  Inj Ropivacaine  Single shot Inj Ropivacaine 0.2% used for adult caudal epidural block 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients belonging to ASA I,II.
2. Patients who give informed written consent. 
 
ExclusionCriteria 
Details  1.Patients refusal for study, patients who underwent a previous lumbar spine surgery
2. Patients with a contraindication to regional anaesthesia
3. Patients with hypersensitivity to ropivacaine.
4. Patients with known cardiac, renal, hepatic, neurological disorders that would interfere with cardiovascular response assessment.
5. Patients with spine abnormalities and body dysmorphism.
6. Patients with coagulopathy or on any anti coagulants.
7. Use of benzodiazepines, anticonvulsants, alcohol, opioids or other psychotropic drugs. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To compare intraoperative opioid consumption
To compare duration of analgesia 		 6-48hrs 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the hemodynamic changes
To compare adverse effects 		 6-48hrs 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 2/ Phase 3 
Date of First Enrollment (India)   30/09/2022 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is a randomized, double blind, parallel group, trial comparing the safety and efficacy of Ropivacaine 0.2% and Ropivacaine 0.2% with Inj Dexamethasone 8mg in 50 patients undergoing lumbar spine surgery that will be conducted in Vydehi medical college and research centre in India. The primary outcome measures will be opioid consumption between the 2 groups and Duration and efficacy of analgesia between the group. The secondary outcomes will be hemodynamic changes in the peri operative period between the group and adverse effects like nausea, vomiting, dowsiness, sedation in post operative period between the two group. 
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