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CTRI Number  CTRI/2025/11/097920 [Registered on: 24/11/2025] Trial Registered Prospectively
Last Modified On: 23/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparison of duration of pain relief after lower limb surgery with dexmedetomidine given in the spinal route or under the skin along with bupivacaine  
Scientific Title of Study   COMPARATIVE STUDY OF DURATION OF POST OPERATIVE ANALGESIA WITH INTRATHECAL VERSUS SUBCUTANEOUS DEXMEDETOMIDINE AS AN ADJUVANT TO 0.5% HYPERBARIC BUPIVACAINE IN LOWER LIMB SURGERIES -A RANDOMIZED CONTROLLED TRIAL 
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 ARATHY C A 
Designation  Junior resident Department of Anaesthesiology  
Affiliation  Jubilee Mission Medical College and Research Institute  
Address  Department of Anaesthesiology Old block 1 st floor Jubilee Mission Medical College and Research Institute P B 737 Fathima Nagar Nellikunnu Thrissur Kerala

Thrissur
KERALA
680005
India 
Phone  9113832894  
Fax    
Email  arathyca1998@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Davies C V 
Designation  Professor Department of Anaesthesiology  
Affiliation  Jubilee Mission Medical College and Research Institute  
Address  Department of Anaesthesiology Old block 1st floor Jubilee Mission Medical College and Research Institute P B 737 Fathima Nagar Nellikunnu Thrissur Kerala

Thrissur
KERALA
680005
India 
Phone  9387890689  
Fax    
Email  daviescv@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Davies C V 
Designation  Professor Department of Anaesthesiology  
Affiliation  Jubilee Mission Medical College and Research Institute  
Address  Department of Anaesthesiology Old block 1st floor Jubilee Mission Medical College and Research Institute P B 737 Fathima Nagar Nellikunnu Thrissur Kerala

Thrissur
KERALA
680005
India 
Phone  9387890689  
Fax    
Email  daviescv@gmail.com  
 
Source of Monetary or Material Support  
Jubilee Mission Mission Medical College and Research Institute P B 737 Fathima Nagar Nellikunnu Thrissur Kerala India 680005 
 
Primary Sponsor  
Name  Jubilee Mission Medical College and Research Institute  
Address  Jubilee Mission Mission Medical College and Research Institute P B 737 Fathima Nagar Nellikunnu Thrissur Kerala India 680005 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 ARATHY C A  JUBILEE MISSION MEDICAL COLLEGE AND RESEARCH INSTITUTE   Department of anesthesiology Ot complex 1 ,old block
Thrissur
KERALA 
9113832894

arathyca1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JUBILEE MISSION MEDICAL COLLEGE & RESEARCH INSTITUTE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 3||Administration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intrathecal dexmedetomidine   Intrathecal dexmedetomidine 5 mcg per kg combined with 0.5% hyperbaric bupivacaine administered during spinal anaesthesia for lower limb surgeries  
Comparator Agent  Subcutaneous dexmedetomidine   Subcutaneous dexmedetomidine 0.5 mcg per kg administered immediately after spinal anesthesia with 0.5% hyperbaric bupivacaine 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  • Patients aged 18 to 60 years
• American Society of Anaesthesiology physical status 1 to 2
• Scheduled for elective lower limb surgeries under spinal anaesthesia
• Duration of surgery should be less than 150 minutes 
 
ExclusionCriteria 
Details  • Known hypersensitive to study drugs
• Contraindications to spinal anaesthesia
• Patients with baseline heart rate <60bpm
• Patient complaints of pain during procedure
• Failed spinal anesthesia
• Addition of any other analgesic medication during procedure 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
duration of postoperative analgesia, measured by
time to first request for analgesics. 
duration of postoperative analgesia, measured by
time to first request for analgesics. 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic parameters monitored intraoperatively  From initiation of spinal anesthesia until the end of surgery (measured at baseline, every 3 minutes for the first 30 minutes, and then every 10 minutes until completion of surgery) 
Duration of sensory and motor block, assessed by standardised scales and time to
regression 
From administration of intrathecal anesthesia until complete regression of sensory and motor block, assessed at regular intervals 
To evaluate overall patients satisfaction post operative.  At 24 hours after surgery 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 3/ Phase 4 
Date of First Enrollment (India)   04/12/2025 
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)   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  

This randomized controlled trial titled “Comparative study of duration of postoperative analgesia with intrathecal versus subcutaneous dexmedetomidine as an adjuvant to 0.5% hyperbaric bupivacaine in lower limb surgeries” aims to evaluate the effectiveness of two routes of dexmedetomidine administration in prolonging postoperative analgesia. The study will be conducted in the Department of Anaesthesiology, Jubilee Mission Medical College and Research Institute, Thrissur, over a period of 18 months. Thirty adult patients aged 18–60 years, belonging to ASA physical status I or II and scheduled for elective lower limb surgeries under spinal anesthesia, will be enrolled and randomly allocated into two groups of fifteen each using computer-generated randomization. Group A will receive 3 mL of 0.5% hyperbaric bupivacaine with 5 µg intrathecal dexmedetomidine and subcutaneous normal saline, while Group B will receive 3 mL of 0.5% hyperbaric bupivacaine intrathecally and 0.5 µg/kg dexmedetomidine subcutaneously. Both the anesthesiologist and the patient will be blinded to group allocation. The primary outcome of the study will be the duration of postoperative analgesia, measured as the time to first request for rescue analgesia. Secondary outcomes include hemodynamic stability, onset and duration of sensory and motor block, incidence of adverse effects such as bradycardia, hypotension, and nausea, total analgesic requirement within 24 hours, and patient satisfaction scores. Data will be analyzed using SPSS version 24, with results expressed as mean ± standard deviation for continuous variables and percentages for categorical variables. Statistical tests such as the independent t-test and chi-square test will be used, and a p-value less than 0.05 will be considered significant. This study seeks to determine whether subcutaneous dexmedetomidine provides analgesic efficacy comparable to intrathecal administration, potentially offering a simpler and safer alternative route for postoperative pain management following lower limb surgeries.

 
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