| CTRI Number |
CTRI/2024/11/076467 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of post operative pain relief after local injection of ropivacaine plus dexmedetomidine versus ropivacaine plus magnesium sulfate in patients undergoing lumbar spine surgeries |
|
Scientific Title of Study
|
Comparison of local infiltration of ropivacaine plus dexmedetomidine versus ropivacaine plus magnesium sulfate for postoperative analgesia in patients undergoing lumbar 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 |
Yashashwini B |
| Designation |
Junior Resident |
| Affiliation |
M S RAMAIAH MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Anaesthesiology, MS Ramaiah Medical College, MSRIT Post, New BEL road, Bangalore-560054
Bangalore
KARNATAKA
560054
India |
| Phone |
8904445721 |
| Fax |
|
| Email |
yashuakshu77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yatish B |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
M S RAMAIAH MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Anaesthesiology, M S Ramaiah Medical College, MSRIT Post, New BEL road, Bangalore-560054
KARNATAKA
560054
India |
| Phone |
9886197658 |
| Fax |
|
| Email |
yatishseeni@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yatish B |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
M S RAMAIAH MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Anaesthesiology, M S Ramaiah Medical College, MSRIT Post, New BEL road, Bangalore-560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9886197658 |
| Fax |
|
| Email |
yatishseeni@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| M S Ramaiah Medical college |
|
|
Primary Sponsor
|
| Name |
M S Ramaiah Medical college |
| Address |
MSRIT Post,New BEL road, Bangalore 560054 |
| 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 Yatish B |
M S Ramaiah Medical College and Hospital |
Department of Anaesthesiology,
second floor, M S Ramaiah Medical College and Hospital NEW BEL road M S Ramaiah nagar MSRIT Post Bangalore
Bangalore
KARNATAKA |
9886197658
yatishseeni@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M S Ramaiah Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
50 mcg of Dexmedetomidine equivalent to 0.5 ml as an additive to 15 ml of 0.75% Ropivacaine with 4.5 ml of normal saline for wound infiltration into paravertebral muscles on each side in patients undergoing spine surgeries |
| Comparator Agent |
Magnesium sulfate |
500 mg of Magnesium sulfate equivalent to 1 ml as an additive to 15ml of 0.75% ropivacaine with 4ml of normal saline for wound infiltration into paravertebral muscles on each side in patients undergoing spine surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists Physical status 1,2 scheduled for elective single/double level spine surgeries such as discectomy, laminectomy, posterior instrumentation under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patient with severe medical conditions like
1.BMI ≥ 30kg/m2
2.Inadequately controlled hypertension or diabetes mellitus
3.Asthma or COPD
4.Ischemic heart disease or other cardiac disorders
5.Kidney or liver diseases
6.Pre-existing cognitive impairment Neurological deficits or psychiatric disorders
7.Chronic use of antipsychotic medications or substance use disorders
8.Pregnancy
9.Patients allergic to ropivacaine, dexmedetomidine or magnesium sulfate |
|
|
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 compare the post operative analgesic effect using VAS score between group RD ( ropivacaine+ dexmedetomidine) and group RM( ropivacaine + MgSO4)
To compare the mean duration of time to first rescue analgesia between group RD and RM
|
at 0 minute, after shifting to post anaesthesia care unit (PACU), 30 minutes, 1st hour, 2nd hour, and thereafter at 4th hour, 6th hour, 12th hour, and 24th hour. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate total analgesic consumption between the study groups.
To compare the post operative analgesic effect using VAS score between the gender.
To assess hemodynamic variables between the study groups.
To assess complication between the study groups.
|
at 0 minute, after shifting to post anaesthesia care unit (PACU), 30 minutes, 1st hour, 2nd hour, and thereafter at 4th hour, 6th hour, 12th hour, and 24th hour. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/11/2024 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In lumbar spine surgeries patients usually complain of severe pain during the initial 12 hours of postoperative period. This causes delayed mobilization and contributes to increased risk of medical complications such as pneumonia, deep vein thrombosis, urinary tract infections and psychological stress.
Wound infiltration with local anaesthetic is an effective strategy. But the pain relief is present only till effects of local anaesthetic action persists.
Hence various adjuvants such as dexmedetomidine, magnesium, clonidine are added to lengthen the duration of action of local anaesthetic.
Dexmedetomidine an alpha -2 adrenoceptor agonist extend the duration of local anaesthetic for pain relief. Magnesium sulfate is a physiological antagonist at NMDA receptor used to enhance the effect of analgesia.
However there are not many clinical studies available to compare the efficacy of magnesium sulfate combined with local anaesthetic drugs for wound site infiltration in lumbar spine surgeries.
Thus we hypothesize that local infiltration of surgical site with ropivacaine and dexmedetomidine likely to provide better post operative analgesia effect in comparison to ropivacaine plus magnesium sulfate as assessed by visual analogue scale (VAS) score. |