| CTRI Number |
CTRI/2023/02/049732 [Registered on: 15/02/2023] Trial Registered Prospectively |
| Last Modified On: |
10/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of addition of a sedative drug Dexmedetomidine in Local Anaesthetic drug Ropivacaine 0.1% concentration mixture with plain Ropivacaine in regional Nerve block given for pain relief after Knee Replacement surgery
|
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Scientific Title of Study
|
comparison of dexmeditomidine as an adjunct to 0.1%ropivacaine to plain ropivacaine in adductor canal block for unilateral total knee replacement:a prospective,double blinded randomized controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SULFATH P |
| Designation |
DNB TRAINEE-ANESTHESIOLOGY |
| Affiliation |
SIR H N RELIANCE FOUNDATION HOSPITAL AND RESEARCH CENTRE |
| Address |
SIR H N RELIANCE FOUNDATION HOSPITAL AND RESEARCH CENTRE,PRARTHANA SAMAJ,RAJA RAMMOHAN ROY ROAD,GIRGOAN,MUMBAI
Mumbai
MAHARASHTRA
400004
India |
| Phone |
7306129766 |
| Fax |
|
| Email |
pzulphath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sheetal Shah |
| Designation |
Consultant Anaesthesiolgist |
| Affiliation |
SIR H N RELIANCE FOUNDATION HOSPITAL AND RESEARCH CENTRE |
| Address |
SIR H N RELIANCE FOUNDATION HOSPITAL AND RESEARCH CENTRE,PRARTHANA SAMAJ,RAJA RAMMOHAN ROY ROAD,GIRGOAN,MUMBAI
Mumbai
MAHARASHTRA
400004
India |
| Phone |
9930996594 |
| Fax |
|
| Email |
sheetalms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SULFATH P |
| Designation |
DNB TRAINEE-ANESTHESIOLOGY |
| Affiliation |
SIR H N RELIANCE FOUNDATION HOSPITAL AND RESEARCH CENTRE |
| Address |
SIR H N RELIANCE FOUNDATION HOSPITAL AND RESEARCH CENTRE,PRARTHANA SAMAJ,RAJA RAMMOHAN ROY ROAD,GIRGOAN,MUMBAI
Mumbai
MAHARASHTRA
400004
India |
| Phone |
7306129766 |
| Fax |
|
| Email |
pzulphath@gmail.com |
|
|
Source of Monetary or Material Support
|
| SIR H N RELIANCE FOUNDATION HOSPITAL AND RESEARCH CENTRE,PRARTHANA SAMAJ,RAJA RAMMOHAN ROY ROAD,GIRGOAN,MUMBAI |
|
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Primary Sponsor
|
| Name |
SIR H N RELIANCE FOUNDATION HOSPITAL AND RESEARCH CENTRE |
| Address |
prarthana samaj,Raja Rammohan Roy road,Girgoan,MUmbai,400004 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SULFATH P |
Sir H N Reliance Foundation Hospital |
Department of Anaesthesiology and Pain Medicine ,Third Floor,H N Reliance Hospital, Prarthana Samaj, Raja Rammohan Roy Rd, Girgaon, Mumbai, Maharashtra 400004
Mumbai
MAHARASHTRA |
7306129766
pzulphath@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC of Sir H N Reliance Foundation Hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, (2) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.1%ropivacaine in adductor canal block |
0.1%ropivacaine will be given through adductor canal catheter after unilateral total knee replacement surgery.The same intervention will be repeated every 6th hourly in first 24 hours |
| Comparator Agent |
adductor canal block |
o.1%ropivacaine+0.5mcg/kg dexmeditomidine given through adductor canal cathetr after unilateral total knee replacement surgery
the same intervention will be repeated every 6th hourly in first 24 hours
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1,2,3 scheduled for unilateral total knee replacement under spinal anesthesia
BMI 20-30kg/m2
|
|
| ExclusionCriteria |
| Details |
allergic to any study drugs
pregnant patients
patients in whom nerve block could not be performed as per methodology
patients on pre operative oral opioids
patients and or relatives not willing for procedure
ASA grade 4 ,age <18 and >80yrs
BMI >30kg/m2
patients on chronic pain medication
any severe perioperative complications
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Other |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To investigate duration of analgesia of ACB using ropivacaine with and without dexmedetomidine after unilateral TKR in first 24 hrs ,both at rest and moving |
6hr,12hr,18hr,24hr |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluate opioid consumption in first 24 hours of surgery |
6hr,12hr,18hr,24hr |
|
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Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
20/02/2023 |
| 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 |
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Publication Details
|
none yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
The main aim of this study is to investigate the duration of analgesia of ACB using ropivacaine with and without dexmedetomidine after unilateral TKR in first 24 hrs, both at rest and moving and to record pain score and opioid consumption among 2 groups.The study population will be composed of patients of either gender,aged above 18 years and below 80 years and posted for unilateral total knee replacement under spinal anesthesia at a tertiary health care centre.Data will be collected between Jan 2023 to july 2024.Analysis of the parameters will be done after complete data collection.At any point of time,the patients enrolled can be dropped out of the study. Sample size is calculated as 64 in number,which will be div ided into 2 groups, control group(C) and Dexmedetomidine group (D).Control group consisting of 0.1% Ropivacaine 20mL and Dexmedetomidine group with 0.1% Ropivacaine + 0.5mcg/kg Demedetomoidine through adductor canal block and Pain assessment done postoperatively evry 6th hourly for 24 hours and results assessed including the Pain score, side effects of adjuvant dexmedetomidine and opiod consumption. |