| CTRI Number |
CTRI/2024/10/075374 [Registered on: 16/10/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
how effective and safe different doses of dexmedetomidine are when combined with ropivacaine, a pain-relief medication, given before surgery in the lower back area. |
|
Scientific Title of Study
|
Comparison of efficacy and safety of different doses of dexmedetomidine combined with ropivacaine for caudal block in lumbosacral surgeries a prospective randomized controlled study |
| 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 Ananya Rao |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
AIIMS RAIPUR |
| Address |
Department of Anesthesiology AIIMS Raipur Raipur Chattisgarh 492099
Raipur
CHHATTISGARH
492099
India |
| Phone |
7338341664 |
| Fax |
|
| Email |
anarao1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Dubey |
| Designation |
Additional Professor |
| Affiliation |
AIIMS RAIPUR |
| Address |
Department of Anesthesiology AIIMS Raipur Raipur Chattisgarh 492099
Raipur
CHHATTISGARH
492099
India |
| Phone |
8839829867 |
| Fax |
|
| Email |
drrashmi1993@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Dubey |
| Designation |
Additional Professor |
| Affiliation |
AIIMS RAIPUR |
| Address |
Department of Anesthesiology AIIMS Raipur Raipur Chattisgarh 492099
Raipur
CHHATTISGARH
492099
India |
| Phone |
8839829867 |
| Fax |
|
| Email |
drrashmi1993@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Tatibandh, GE road, Raipur, Chattisgarh 492099, India |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Ananya Rao |
AIIMS RAIPUR |
Department of Anesthesiology, Neurosurgery OT,Superspeciality OT complex 4th floor , B block, Raipur, Chhattisgarh
Raipur
CHHATTISGARH |
7338341664
anarao1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M45-M49||Spondylopathies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine 1mcg/kg |
Caudal block with dexmedetomidine 1mcg/kg and ropivacaine under USG guidance |
| Intervention |
Dexmedetornidine 2mcg/kg |
Caudal block with dexmedetomidine 2mcg/ kg and ropivacaine under USG guidance |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient scheduled for lumbosacral spine surgery
Patient aged between 18years to 65years
Patient with ASA grades 1 and 2 with both the sexes |
|
| ExclusionCriteria |
| Details |
Patient not willing to consent
Patients with coexisting diseases like uncontrolled hypertension, diabetes, asthma, history of MI, CAD, etc
Patients with preoperative opioid consumption
Patients who underwent a previous lumbar spine surgery
Patients with contraindications to regional anesthesia like the history of coagulopathies, preexisting neurologic deficit, active infection at the site of injection,etc
Patients with hypersensitive to ropivacaine and dexmedetomidine
Any lumbosacral anamoly
Surgery exceeding more than 5hours
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate and compare the analgesic effect of caudal epidural injection of different doses of dexmedetomidine with ropivacaine postoperatively
|
Intraoperative and postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.assess the hemodynamic effects of dexmedetomidine intraoperatively
2. To see the incidence of adverse effects between the two doses |
Intraoperative and postoperative period |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
28/10/2024 |
| 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="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
|
The rise in spine pathology correlates with increased mechanized work and sedentary lifestyles, leading to a higher demand for spinal surgeries. Postoperative pain from lumbosacral surgeries is often due to irritation of nociceptors and mechanoreceptors, and it can persist long after surgery due to inflammatory processes. This pain can delay mobilization, increasing the risk of complications such as pneumonia and deep vein thrombosis. Caudal analgesia offers a reliable method for managing intraoperative and postoperative pain. Preemptive analgesia can also reduce sensitization from noxious stimuli. Ropivacaine, a local anesthetic, provides effective pain relief while preserving motor function. The current trend favors multimodal pain control, incorporating adjuvants like dexmedetomidine, which enhances local anesthetic efficacy. Despite the benefits, there are limited randomized studies on preemptive caudal analgesia in lumbosacral surgeries. This study aims to compare the analgesic effects and side effects of different doses of dexmedetomidine combined with ropivacaine when given as single shot caudal epidural block preemptively. |