| CTRI Number |
CTRI/2025/04/084862 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Ropivacaine with Dexmedetomidine versus Ropivacaine with Magnesium Sulfate for Pain Relief After Lumbar Spine Surgery |
|
Scientific Title of Study
|
A Randomized study to Compare Analgesic Efficacy of Ropivacaine with Dexmedetomidine Versus Ropivacaine with Magnesium fulfate in Surgical Site Infiltration in Patients Undergoing Lumbar Spine Fixation Surgery under General Anaesthesia |
| 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 Shobha Purohit |
| Designation |
Senior Professor |
| Affiliation |
SMS medical college and hospital |
| Address |
Department of Anaesthesiology Neuro Operation Theatre SMS Medical College And Hospital
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414059823 |
| Fax |
|
| Email |
Purohit.shobha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Shobha Purohit |
| Designation |
Senior Professor |
| Affiliation |
SMS medical college and hospital |
| Address |
Department of Anaesthesiology Neuro Operation Theatre SMS Medical College And Hospital
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414059823 |
| Fax |
|
| Email |
Purohit.shobha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manish Kumar |
| Designation |
Resident Doctor |
| Affiliation |
SMS medical college and hospital |
| Address |
Department of Anaesthesiology Neuro Operation Theatre SMS Medical College And Hospital
Jaipur
RAJASTHAN
302004
India |
| Phone |
7273014253 |
| Fax |
|
| Email |
mkrk994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology SMS Medical College And Hospital Jaipur Rajasthan 302004 |
|
|
Primary Sponsor
|
| Name |
SMS Medical College And Hospital |
| Address |
Department of Anaesthesiology SMS Medical College And hospital Jaipur Rajasthan 302004 |
| Type of Sponsor |
Government 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 Shobha Purohit |
SMS Medical College And Hospital |
Department of Anaesthesiology Neuro Operation Theatre
Jaipur
RAJASTHAN |
9414050823
Purohit.Shobha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical College And Associated Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G952||Other and unspecified cord compression, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ropivacaine combined with Magnesium Sulfate |
Patients in the comparator group will receive a combination of ropivacaine and magnesium sulfate (a mineral with analgesic properties) for surgical site infiltration during lumbar spine surgery. Local infiltration of 15ml of 0.5% Ropivacaine with 500mg Magnesium sulfate equivalent to 1ml plus 4ml Normal saline at surgical site .Magnesium sulfate’s potential in enhancing the analgesic effect of local anesthetics will be evaluated in comparison to dexmedetomidine. |
| Intervention |
Ropivacaine combined with Dexmedetomidine |
Patients in the intervention group will receive a combination of ropivacaine (a local anesthetic) and dexmedetomidine (an alpha-2 adrenergic agonist) for surgical site infiltration during lumbar spine surgery. 15ml of 0.5% Ropivacaine with 50microgram Dexmedetomidine equivalent to 0.5ml plus 4.5ml of Normal Saline will be administered at surgical site . The aim is to assess the combined effect of local anesthesia and the analgesic properties of dexmedetomidine in improving post-operative pain control and reducing opioid consumption. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to give written and informed consent
Patients undergoing lumbar spine fixation surgery
Patients with ASA physical status 1 or 2 |
|
| ExclusionCriteria |
| Details |
Non cooperative patients
BMI more than 35kg/m2
History of allergy to any other drugs used during the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To asses and compare mean NRS score at different intervals between the study groups
To assess and compare in mean time of first rescue analgesia intravenous Diclofenac between the study groups
To asses and compare the difference in mean total number of doses of intravenous Diclofenac in 24 hours postoperatively between the study groups |
Just after extubation ,2hours ,6hours ,12hours, 24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess and compare post operative hemodynamic vitals between the study groups
To determine the proportion of patients experiencing side effects between study groups |
Up to 24 hours of extubation |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
27/04/2025 |
| 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="0"
Months="2"
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 study aims to compare the analgesic efficacy of two combinations of medications used for surgical site infiltration in patients undergoing lumbar fixation surgery. Specifically, it will evaluate Ropivacaine combined with Dexmedetomidine versus Ropivacaine combined with Magnesium sulfate. The study will measure postoperative pain relief using Numerical Rating scale (NRS) scores at various time points, the time to first analgesic request, and total analgesic consumption. Additionally, it will monitor side effects such as hypotension, bradycardia, and nausea. This prospective, randomized, double-blind trial will provide insights into which combination offers superior pain control, potentially improving post-surgical recovery and reducing the need for opioids. |