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CTRI Number  CTRI/2018/07/014866 [Registered on: 13/07/2018] Trial Registered Prospectively
Last Modified On: 12/07/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Addition of Dexamethasone to Levobupivacaine in Quadratus Lumborum block may or may not provide better pain relief in Inguinal hernia repair. 
Scientific Title of Study   Comparison of the postoperative analgesic efficacy of Levobupivacaine alone and with Dexamethasone in ultrasound guided Quadratus Lumbor 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sangeeta Choudhary 
Designation  Junior Resident 
Affiliation  Dr. S.N.Medical College, Jodhpur 
Address  Department of Anaesthesiology and Critical care, Dr.S.N.Medical College,Jodhpur, Rajasthan.

Jodhpur
RAJASTHAN
342003
India 
Phone  7597891025  
Fax    
Email  sangeeta.home22@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sangeeta Choudhary 
Designation  Junior Resident 
Affiliation  Dr. S.N.Medical College, Jodhpur 
Address  Department of Anaesthesiology and Critical care, Dr.S.N.Medical College,Jodhpur, Rajasthan.

Jodhpur
RAJASTHAN
342003
India 
Phone  7597891025  
Fax    
Email  sangeeta.home22@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Geeta Singariya 
Designation  Professor, Department of Anaesthesiology and Critical care, Jodhpur. 
Affiliation  Dr. S.N.Medical College, Jodhpur. 
Address  Department of Anaesthesiology and Critical care, Dr.S.N.Medical College, Jodhpur.

Jodhpur
RAJASTHAN
342003
India 
Phone  9414803554  
Fax    
Email  geetamanojkamal@gmail.com  
 
Source of Monetary or Material Support  
Dr. S.N.Medical College, Jodhpur 
 
Primary Sponsor  
Name  Dr SN Medical College and Attached group of Hospitals 
Address  Shastri Nagar, Jodhpur, Rajasthan - 342003 
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 Sangeeta Choudhary  MDM Hospital  Operation Theatre complex, Department of Anaesthesiology and critical care, Jodhpur, Rajasthan.
Jodhpur
RAJASTHAN 		 7597891025

sangeeta.home22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. S.N. Medical College Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ASA Grade 1 and 2,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexamethasone  GROUP D: Patient will receive 20 ml 0.25% Inj. Levobupivacaine + 1 ml Inj. Dexamethasone (4mg/ml) with a total volume of 21 ml. 
Comparator Agent  Normal saline  GROUP L: Patient will receive 20 ml 0.25% Inj. Levobupivacaine + 1 ml Normal saline with a total volume of 21 ml. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age group of 18 –60 years of both sexes
2. ASA grade I and II
3. Weight 50-90 kg
4. Patients scheduled for elective unilateral inguinal hernia repair
 
 
ExclusionCriteria 
Details  1. Patient’s or relative’s refusal
2. Known hypersensitivity to local anesthetics
3. Opioid addict
4. Any chronic systemic illness
5. Bleeding diathesis
6. Severe stenotic heart diseases
7. Anatomical abnormality
8. Any infection at the regional site
9. Pregnant women
10. Pre existing peripheral neuropathy or neurological deficits
 
 
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 
1. To compare the duration of analgesia.
2. To compare post operative rescue analgesic requirement in first 24 hours.
3. Post-operative NRS ( Numerical Rating Scale ) scores.
 		 24 hours
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the hemodynamic and respiratory parameters.
2. Any side effects or complications of study drugs and block.
3. Patient’s satisfaction.
 		 24 hours 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   15/07/2018 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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)?  

Brief Summary   This is a prospective randomised double blind study. Institutional ethical committee clearance obtained and informed consent would be taken from the patient. The total of 90 patients between the age 18 to 60 years of ASA grade 1 and 2 undergoing unilateral inguinal hernioplasty would be randomly divided into 2 groups of 45 each. After surgery under spinal anaesthesia, Group L will receive 0.25 % Levobupivane  20 ml + 1 ml 0.9 % normal saline and Group D will receive 0.25% 20 ml Levobupivacaine + 1 ml Dexamethasone (4 mg/ml) with a total of 21 ml in each group in ultrasound guided type 1 (lateral) Quadratus Lumborum block. Postoperatively, we will record and compare the duration of analgesia, total rescue analgesic (Tramadol) requirements and NRS pain scores in first 24 hours. 
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