| CTRI Number |
CTRI/2024/11/076433 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
29/10/2024 |
| 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
|
A Clinical Study to compare the efficacy of intraperitoneal instillation of ropivacaine with dexmeditomedine versus ropivacaine in total laproscopic hysterectomy |
|
Scientific Title of Study
|
Intraperitoneal instillation of Ropivacaine with Dexmedetomidine versus
Ropivacaine alone for post operative analgesia in patients undergoing total
laproscopic hysterectomy: A randomized 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 |
viraj pradeep kakade |
| Designation |
junior resident |
| Affiliation |
NKPSIMS and RC and LMH digdoh hills hingana nagpur |
| Address |
Department of Anaesthesiology, 4th floor, NKP salve institute of medical sciences and research centre and lata mangeshkar hospital, digdoh hills,hingna, nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
8177986997 |
| Fax |
|
| Email |
virajkakade29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tilka Ghate |
| Designation |
Associate Professor, Department Of Anaesthesia |
| Affiliation |
Nkp salve institute of medical sciences and research centre and lata mangeshkar hospital |
| Address |
Department of anaesthesiology, 4th Floor, NKP salve institute of medical sciences and research centre and lata mangeshkar hospital, digdoh hills,hingna, nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
8446095872 |
| Fax |
|
| Email |
tilkavghate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
viraj pradeep kakade |
| Designation |
Junior Resident |
| Affiliation |
Nkp salve institute of medical sciences and research centre and lata mangeshkar hospital |
| Address |
Department of anaesthesiology, 4th Floor, NKP salve institute of medical sciences and research centre and lata mangeshkar hospital, digdoh hills,hingna, nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
8177986997 |
| Fax |
|
| Email |
virajkakade29@gmail.com |
|
|
Source of Monetary or Material Support
|
| NKP salve institute of medical sciences and research centre and lata mangeshkar hospital, digdoh hills,hingna, nagpur |
|
|
Primary Sponsor
|
| Name |
NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital |
| Address |
d research centre and Lata Mangeshkar Hospital, Digdoh Hills ,Hingna, Nagpur,440019 |
| 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 |
| VIRAJ KAKADE |
NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital |
Department of Anaesthesiology, NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital, digdoh hills ,hingana ,Nagpur
Nagpur
MAHARASHTRA |
8177986997
virajkakade29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Comittee NKP salve institute of medical sciences and research centre and Lata Mangeshkar Hospital |
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 |
Intraperitoneal instillation |
Inj Ropivacaine 0.5% 30cc before closure |
| Comparator Agent |
Intraperitoneal Instillation |
Injection Ropivacaine 0.25% 30ml with Injection Dexmedetomidine 0.5 mcg/kg before closure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
participants scheduled for total laproscopic hysterectomy |
|
| ExclusionCriteria |
| Details |
history of hypersensitivity to study drug
pregnancy
past history of peritonitis
patients on any adrenergic agonist and antagonist |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of intraperitoneal instillation of Ropivacaine with Dexmedetomidine and Ropivacaine alone for post operative analgesia in patients undergoing total laproscopic hysterectomy in terms of:
Visual Analog Scale (VAS)
Time to first rescue analgesia
Total amount of rescue analgesic in 24 hrs.
|
0hr ,0.5 hr,1hr,2hr,4 hr,8hr,12 hr,24hr.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
11/11/2024 |
| 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="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
|
nil |