| CTRI Number |
CTRI/2024/07/071595 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of drug given either single dose every 5 hourly or continuous infusion pump for postoperative pain relief in bone surgeries |
|
Scientific Title of Study
|
Comparative evaluation of dexmedetomidine ropivacaine bolus VS Dexmedetomidine ropivacaine via elastomeric infusion pump for epidural analgesia in lower limb Orthopaedic surgery |
| 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 Supriya Maurya |
| Designation |
Junior resident |
| Affiliation |
Lala lajpat Rai memorial medical College meerut |
| Address |
Department of anaesthesia Lala Lajpat Rai memorial medical College meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
7985414931 |
| Fax |
|
| Email |
supriyamaurya9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod chand |
| Designation |
Associate Professor |
| Affiliation |
Lala lajpat Rai memorial medical College meerut |
| Address |
Department of anaesthesia Lala Lajpat Rai memorial medical College meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9557040620 |
| Fax |
|
| Email |
pcllrm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pramod chand |
| Designation |
Associate Professor |
| Affiliation |
Lala lajpat Rai memorial medical College meerut |
| Address |
Department of anaesthesia Lala Lajpat Rai memorial medical College meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9557040620 |
| Fax |
|
| Email |
pcllrm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia Lala Lajpat Rai memorial medical College meerut uttar pradesh pin code 250004 |
|
|
Primary Sponsor
|
| Name |
Dr Supriya Maurya |
| Address |
Department of anaesthesia Lala Lajpat Rai memorial medical College meerut uttar pradesh pin code 250004 |
| Type of Sponsor |
Other [Other (self)] |
|
|
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 Pramod chand |
Sardar Vallabhbhai Patel hospital |
Department of anaesthesia Lala Lajpat Rai memorial medical College
Meerut
UTTAR PRADESH |
9557040620
pcllrm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee sardar Vallabhbhai Patel hospital Meerut |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S723||Fracture of shaft of femur, (2) ICD-10 Condition: S822||Fracture of shaft of tibia, (3) ICD-10 Condition: V235||Motorcycle passenger injured in collision with car, pick-up truck or van in traffic accident, (4) ICD-10 Condition: M255||Pain in joint, (5) ICD-10 Condition: R52||Pain, unspecified, (6) ICD-10 Condition: S730||Subluxation and dislocation of hip, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Epidural analgesia for post operative pain relief in lower limb orthopaedic surgery |
Group A - 0.2% Ropivacaine(6ml) + dexmedetomidine(1mcg/kg) bolus
Group B- 0.2% Ropivacaine+ dexmedetomidine 1mcg/kg via elastomeric infusion pump
For postoperative analgesia we will observe patient for 48 hour. |
| Comparator Agent |
Epidural analgesia through bolus dose |
Group A 6ml bolus dose of 0.2% ropivacaine +1mcg/kg dexmedetomidine every 5 hourly for 48 hours and efficacy ,quality of analgesia with haemodynamic parameters accessed for 48 hours |
| Comparator Agent |
Epidural analgesia through elastomeric infusion pump |
Group B _.2% ropin + 1mcg/kg dexmedetomidine infusion is given postoperatively to patients undergoing Lower Limb orthopaedic Surgery via elastomeric infusion pump at 3ml/ hour for 48 hours and efficacy, quality of analgesia, haemodynamic parameters assessed for 48 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1- ASA class 2 and 3
2- Age 18-75 years
3-Patients undergoing lower limb orthopaedic surgery |
|
| ExclusionCriteria |
| Details |
1- Infection at injection site.
2-Communication difficulty that would prevent postoperative assessment
3- Any contraindications to epidural anesthesia
4- ASA class 4 |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary objective to compare postoperative analgesia in 2 groups with same drug but different delivery method one bolus and other elastomeric infusion pump postoperatively. |
Primary objective to compare efficacy and quality of postoperative analgesia in 2 groups with same drug but different delivery method one bolus and other elastomeric infusion pump for 48 hours postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1-comparison of haemodynamic changes in 2 groups.
2-Any complications of epidural anesthesia
3-Any side effects of drug in the study. |
For 48 hour. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Pain an unpleasant sensory and emotional experience associated with actual or potential tissue damage. While studying of reasonable census about use of ropivacaine dexmedetomidine via epidural for analgesia, I found there is scant literature about efficacy of infusion of drug (ropivacaine -dexmedetomidine) via elastomeric infusion pump VS bolus dose .So, We planned to conduct an analytical study cohort of 80 postoperative orthopaedic patients to compare the efficacy,quality of analgesia, haemodynamic stability in these 2groups. |