| 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
|
|
|
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
|
|
|
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. |