| 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
|
|
|
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
|
|
|
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. |