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CTRI Number  CTRI/2025/01/079169 [Registered on: 21/01/2025] Trial Registered Prospectively
Last Modified On: 21/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison of using Ropivacaine with Dexmedetomedine and Ropivacaine with Clonidine for pain relief after spine surgeries 
Scientific Title of Study   A comparative study of epidural Ropivacaine with Dexmedetomedine and Ropivacaine with Clonidine for post operative analgesia in spine surgeries. 
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 Aishwarya Sanjay Borode 
Designation  Junior Resident 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Radhikabai Hostel, DMIHER Campus, Sawangi (Meghe), Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  7020591048  
Fax    
Email  aishwaryaborode7@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dhawal Rameshpant Wadaskar 
Designation  Associate Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Anaesthesia, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9619635778  
Fax    
Email  dhawal104@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Dhawal Rameshpant Wadaskar 
Designation  Associate Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Anaesthesia, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9619635778  
Fax    
Email  dhawal104@gmail.com  
 
Source of Monetary or Material Support  
Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra , India 442001  
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research 
Address  Datta Meghe Institute of Higher Education and Research, Sawangi ( Meghe) , Wardha-442001  
Type of Sponsor  Private 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 Aishwarya Sanjay Borode  Acharya Vinoba Bhave Rural Hospital   In patient department , Department of Aanesthesiology ,Acharya Vinoba Bhave Rural Hospital , Sawangi (Meghe) Wardha Maharashtra
Wardha
MAHARASHTRA 
7020591048

aishwaryaborode7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH  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, (2) ICD-10 Condition: M20-M25||Other joint disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Clonidine  2 mcg/kg of Clonidine in addition to 20 ml of 0.2% Ropivacaine for a period of 2 years. 
Intervention  Dexmedetomedine  1 mcg/kg of Dexmedetomidine along with 20 ml of Ropivacaine 0.2% for a period of 2 year . 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Individuals between the ages of 18 and 60 years.
2.patients scheduled for elective spine surgery like laminectomies, discectomies, spinal fusions, and other spinal operations.
3.Patients with physical status classes I through II according to the American Society of Anesthesiologists (ASA).
4.Patients who are capable of giving their informed consent to take part in the trial.
 
 
ExclusionCriteria 
Details  1.Patients in whom epidural anaesthesia is contraindicated.
2.Patients having established allergies to any of the research medications .
3.Patients who have had opioid dependency or persistent pain in the past.
4.Pregnant or lactating females.
5.Patients with spinal cord injuries or neurological deficiencies.
5.Patients with a background of severe renal, hepatic, or cardiovascular illness.
6.Patients who are unable to assist with data collection or pain assessment (for example, because of cognitive disability).
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain Score (VAS)
Duration of Analgesia
Vital Parameters
Adverse effects if any 
Pain Score (VAS)
Duration of Analgesia
Vital Parameters
Adverse effects if any for period of 48 hours . 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 4 
Date of First Enrollment (India)   01/02/2025 
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="1"
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  

Background –

Managing pain following spinal surgery is still a clinical challenge. For patients to remain comfortable and heal properly, post-operative pain management must be effective. Research has been done on epidural analgesia as a possible treatment option for post-operative pain following spine procedures. Given the ability to enhance hemodynamic stability and pain reduction, α2 adrenergic agonists are proposed as adjuvants to local anaesthetics in this regard.

Objectives –

The objective of this protocol is to contrast and assess the efficiency of two different α2 adrenergic agonists, dexmedetomidine and clonidine, given in conjunction with epidural ropivacaine as adjuvants for post-operative analgesia following spine procedures. The primary objective is to evaluate the effectiveness of these analgesics in relieving pain; other goals include comparing the amount of opioids used, monitoring hemodynamic parameters, and adverse effects, and improving patient satisfaction.

Methods –

The research will be done as a prospective, double-blinded, randomised clinical trial. Random assignment will be used to allocate patients to one of two groups: either the Ropivacaine with Clonidine or the Ropivacaine with Dexmedetomidine group. A number of variables will be observed and compared between the two groups, including patient satisfaction, hemodynamic measurements, opioid use, pain scores, and side effects.

Conclusion –

The necessity of efficient post-operative pain control in spinal operations makes this study significant. This study intends to provide important insights into enhancing patient comfort and safety by contrasting the use of clonidine and dexmedetomidine with epidural ropivacaine. The findings of this study may influence clinical practice and result in more individualised pain management plans for individuals undergoing spine surgery while limiting the negative effects of opioids.

 
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