| CTRI Number |
CTRI/2024/04/065598 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of analgesic efficacy of Local Wound Infiltration with Levobupivacaine Plus Dexmedetomidine And Ropivacaine Plus Dexmedetomidine in Lower Abdominal Surgeries : A Randomised controlled trial |
|
Scientific Title of Study
|
COMPARISON OF ANALGESIC EFFICACY OF LOCAL WOUND INFILTRATION WITH LEVOBUPIVACAINE PLUS DEXMEDETOMIDINE AND ROPIVACAINE PLUS DEXMEDETOMIDINE IN LOWER ABDOMINAL SURGERIES: A RANDOMISED CONTROLLED TRIAL |
| 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 G Vignesh |
| Designation |
Post Graduate |
| Affiliation |
Karpaga Vinayaga Institute Of Medical Sciences and Research Centre |
| Address |
Department Of Anaesthesia
Karpaga Vinayaga Institute Of Medical Sciences and Research Centre,
GST Road,
Chinna Kolambakkam,
Palayanoor (PO),
Madhuranthagam (TK),
Kancheepuram (DT) 603 308.
Department Of Anaesthesia
Karpaga Vinayaga Institute Of Medical Sciences and Research Centre,
GST Road,
Chinna Kolambakkam,
Palayanoor (PO),
Madhuranthagam (TK),
Kancheepuram (DT) 603 308.
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9786250754 |
| Fax |
|
| Email |
gvignesh791@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Murali Manoj |
| Designation |
Professor |
| Affiliation |
Karpaga Vinayaga Institute Of Medical Sciences and Research Centre |
| Address |
Department Of Anaesthesia
Karpaga Vinayaga Institute Of Medical Sciences and Research Centre,
GST Road,
Chinna Kolambakkam,
Palayanoor (PO),
Madhuranthagam (TK),
Kancheepuram (DT) 603 308.
GST Road,
Chinna Kolambakkam,
Palayanoor (PO),
Madhuranthagam (TK),
Kancheepuram (DT) 603 308.
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9791990979 |
| Fax |
|
| Email |
mmm.slazenger@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Vignesh |
| Designation |
Post Graduate |
| Affiliation |
Karpaga Vinayaga Institute Of Medical Sciences and Research Centre |
| Address |
Department Of Anaesthesia
Karpaga Vinayaga Institute Of Medical Sciences and Research Centre,
GST Road,
Chinna Kolambakkam,
Palayanoor (PO),
Madhuranthagam (TK),
Kancheepuram (DT) 603 308.
GST Road,
Chinna Kolambakkam,
Palayanoor (PO),
Madhuranthagam (TK),
Kancheepuram (DT) 603 308.
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9786250754 |
| Fax |
|
| Email |
gvignesh791@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karpaga Vinayaga Institute Of Medical Sciences and Research Centre,
GST Road,
Chinna Kolambakkam,
Palayanoor (PO),
Madhuranthagam (TK),
Kancheepuram (DT) 603 308.
|
|
|
Primary Sponsor
|
| Name |
Dr G Vignesh |
| Address |
Post Graduate,
Department Of Anaesthesia
Karpaga Vinayaga Institute Of Medical Sciences and Research Centre,
GST Road,
Chinna Kolambakkam,
Palayanoor (PO),
Madhuranthagam (TK),
Kancheepuram (DT) 603 308. |
| Type of Sponsor |
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 G Vignesh |
Karpaga Vinayaga Institute of Medical Sciences and Research Centre |
Department Of Anaesthesia
Karpaga Vinayaga Institute Of Medical Sciences and Research Centre,
GST Road,
Chinna Kolambakkam,
Palayanoor (PO),
Madhuranthagam (TK),
Kancheepuram (DT) 603 308.
Kancheepuram
TAMIL NADU |
09786250754
gvignesh791@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee(Human studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
levobupivacaine(0.25%) plus dexmedetomidine 100mcg |
Levobupivacaine 0.25% plus dexmedetomidine 100mcg to
find out the better analgesic efficacy of levobupivacaine 0.25% Plus Dexmedetomidine 100mcg in first 24hrs when infiltrated locally in patients undergoing Lower Abdominal Surgeries |
| Comparator Agent |
Ropivacaine 0.25% plus Dexmedetomidine 100mcg |
Ropivacaine (0.25%) Plus Dexmedetomidine
study group to
find out better analgesic efficacy of Ropivacaine Plus Dexmedetomidine compared to Levobupivacaine 0.25% plus dexmedetomidine 100mcg in first 24hrs when infiltrated locally in patients undergoing Lower Abdominal Surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ASA classification I & II
Age of 18 to 60yrs
Posted for elective lower abdominal surgeries
Surgical duration of 1hr to 2hrs
|
|
| ExclusionCriteria |
| Details |
Patient Refusal
Allergic to local anaesthetics
Failed Sub Arachnoid Block getting converted to GA
Patchy Sub Arachnoid Block
Obese Individual
Lower Segment Caesarean Section
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Compare the efficacy of post operative analgesia of two drugs at 30mins,4hrs,8hrs,12hrs,20hrs,
24hrs and their analgesic duration
|
To Compare the efficacy of post operative analgesia of two drugs at 30mins,4hrs,8hrs,12hrs,20hrs,
24hrs and their analgesic duration
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Frequency of rescue analgesia whenever VAS score more than or equal to 4 in first 24hrs |
4hrs,8hrs,12hrs,20hrs,
24hrs |
|
|
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)
|
30/04/2024 |
| 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="0"
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
|
To compare the better analgesic efficacy of infiltration of the two drugs with additives i.e., levobupivacaine with dexmedetomidine and ropivacaine with dexmedetomidine for postoperative pain relief in patients undergoing lower abdominal surgeries
Levobupivacaine with dexmedetomidine and ropivacaine with dexmedetomidine were the two drugs with adjuvants used for better post operative pain relief and reduce the frequency of rescue analgesia.
Purpose of this study to get better post operative pain relief and reduce the frequency of rescue analgesia and it is cost effective also. |