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CTRI Number  CTRI/2024/11/076848 [Registered on: 14/11/2024] Trial Registered Prospectively
Last Modified On: 10/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of opioid free anaesthesia by using retrolaminar block  
Scientific Title of Study   “Comparision of opioid free anaesthesia by using bilateral retrolaminar block with conventional opioid based anaesthesia for improved recovery in patients undergoing lumbar laminectomy: A randomised controlled interventional study” 
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 Dhamodharan M 
Designation  Post graduate resident 
Affiliation  Dr S N medical college 
Address  Department of Anaesthesiology, MDM hospital, Dr S N medical college, Jodhpur Rajasthan- 342003

Jodhpur
RAJASTHAN
342003
India 
Phone  9944114936  
Fax    
Email  dhamodharanm1997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Fateh Singh Bhati 
Designation  Senior professor 
Affiliation  Dr S N medical college 
Address  Department of Anesthesiology Dr S N medical college Jodhpur

Jodhpur
RAJASTHAN
342003
India 
Phone  9461028789  
Fax    
Email  fatehbhati68@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gayatri tanwar  
Designation  Assistant professor  
Affiliation  Dr S N medical college 
Address  Department of Anesthesiology Dr S N medical college Jodhpur

Jodhpur
RAJASTHAN
342003
India 
Phone  9116096664  
Fax    
Email  gayatri.tanwar@gmail.com  
 
Source of Monetary or Material Support  
Dr S N medical college, Jodhpur Rajasthan India - 342003 
 
Primary Sponsor  
Name  Dr Dhamodharan M 
Address  Department of Anaesthesiology, MDM hospital, DR S N Medical college Jodhpur Rajasthan India- 342003 
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 Dhamodharan M  Dr S N medical college  OT 7,NEUROSURGERY OT,Department of Anaesthesiology,mdm hospital,Residency Rd, Sector-D, Shastri Nagar, Jodhpur, Rajasthan 342003
Jodhpur
RAJASTHAN 		 9944114936

dhamodharanm1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Dr SN Medical College Jodhpur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  opiod based anaesthesia  laminectomy conducted under normal opioid based general anaesthesia with fentanyl in premedication and repeated at regul;at intervals for analgesia 
Intervention  retrolaminar block  administration of bilateral retrolaMinar block by the operating surgeon directly into the retrolaminar space after skin incision.Administered only once during surgery and monitoring done during intraoperative and postoperative period without any further intervention 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Body mass index (BMI): 18–28kg/m2
American Standards Association (ASA) grade I–II; Patients undergoing elective surgeries of lumbar laminectomy 
 
ExclusionCriteria 
Details  Patient refusal
2) History of allergy to study drugs;
3) Pregnant and lactating females
4) Lower limb weakness with motor or sensory disturbances
4) History of chronic pain or long-term use of psychotropic drug or substance
abuse 
 
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 recovery time   assessed postoperatively at the time of baseline during extubation 
 
Secondary Outcome  
Outcome  TimePoints 
tracheal extubation time  assessed at the time of baseline 
discharge from PACU  assessed at the time of 15 mins from baseline 
pain score at rest & movement using VAS   timed intervals at every half an hour from baseline to 24 hours postoperatively 
duration of analgesia  assessed every half an hour from the time of baseline 
total tramadol consumption  assessed for 24hours of postoperative period from baseline 
postoperative side effects such as nausea & vomiting  during 24hours of postoperative period from baseline 
 
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   N/A 
Date of First Enrollment (India)   21/11/2024 
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="6"
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   The study aims for comparision of opioid free anaesthesia by using bilateral retrolaminar
block with conventional opioid based anaesthesia for improved recovery in patients undergoing
lumbar laminectomy 
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