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CTRI Number  CTRI/2022/05/042588 [Registered on: 17/05/2022] Trial Registered Prospectively
Last Modified On: 13/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of postoperative pain for 0.5% hyperbaric bupivacaine given as spinal block with intravenous or spinal dexmedetomidine in abdominal hysterectomy. 
Scientific Title of Study   Comparison of intravenous and intrathecal dexmedetomidine as adjuvants to 0.5% hyperbaric bupivacaine for post operative analgesia in abdominal hysterectomy. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Durga lal yadav 
Designation  Post graduate student 
Affiliation  J.L.N. Medical college and hospital 
Address  Department of anaesthesiology J.L.N.Medical college and hospital, Ajmer Rajasthan - 305001

Ajmer
RAJASTHAN
305001
India 
Phone  9252255176  
Fax    
Email  drdly10@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Veena Patodi 
Designation  Senior professor 
Affiliation  J.L.N. medical college and hospital 
Address  Department of anaesthesiology J.L.N.Medical college and hospital, Ajmer Rajasthan - 305001

Ajmer
RAJASTHAN
305001
India 
Phone  9414008276  
Fax    
Email  veenapatodi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Veena Patodi 
Designation  Senior professor 
Affiliation  J.L.N. medical college and hospital 
Address  Department of anaesthesiology J.L.N.Medical college and hospital, Ajmer Rajasthan - 305001

Ajmer
RAJASTHAN
305001
India 
Phone  9414008276  
Fax    
Email  veenapatodi@gmail.com  
 
Source of Monetary or Material Support  
J.L.N. medical college and hospital,Ajmer,Rajasthan, India - 305001 
 
Primary Sponsor  
Name  JLN medical college and hospital 
Address  J.L.N. medical college and hospital, ajmer, Rajasthan - 305001 
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 Durga lal yadav  J.L.N medical college and hospital  Department of anaesthesiology J.L.N. medical college and hospital
Ajmer
RAJASTHAN 		 9252255176

drdly10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical commitee, J.L.N. medical college, Ajmer  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 
Comparator Agent  0.5% hyperbaric bupivacaine intrathecal with intrathecal dexmedetomidine or intravenous dexmedetomidine.  Given 0.5% hyperbaric bupivacaine 3ml intrathecal with 5mcg intrathecal dexmedetomidine or 1mcg/kg intravenous dexmedetomidine once prior surgery and Compare the duration of analgesia postoperatively and duration of study for 1 year. 
Intervention  Intrathecal block   Intrathecal block prior surgery using 0.5% hyperbaric bupivacaine 3ml with intrathecal dexmedetomidine 5mcg or intravenous dexmedetomidine 1mcg/kg and Duration of analgesia is assessed postoperatively and duration of study is around 1 year 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1.body weight 40 to 80 kg.
2.Patient belonging to ASA class I and II.
3.Patient undergoing abdominal surgery. 
 
ExclusionCriteria 
Details  1.Patient refusal or uncooperative patient.
2.Any known hypersensitivity or contraindication to bupivacaine, dexmedetomidine.
3.Local pathology at the site of injection or disability limiting the performance of spinal block.
History of convulsion, bleeding disorder, severe neurological deficit, thyroid disorder.
Patient with history of respiratory,cardiac,hepatic or renal disease.
Patient having a history of significant neurological,psychiatric or neuromuscular disorders.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of analgesia.  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Onset and recovery(time to 2 segment regression) of sensory block.
Onset and recovery of motor block,
Peri operative sedation score.
Haemodyanamic changes.
Adverse effect if any. 		 1 year 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   20/05/2022 
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="0"
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
Modification(s)  		 The aim of our study is compare of intravenous and intrathecal dexmedetomidine as adjuvants to 0.5% hyperbaric bupivacaine in abdominal hysterectomy with respect to
PRIMARY OBJECTIVE : Duration of post operative analgesia
SECONDARY OBJECTIVES : Onset and recovery of sensory block, onset or recovery of motor block, peri operative sedation score,haemodyanamic changes, adverse effect if any.
 
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