| CTRI Number |
CTRI/2024/12/078007 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the best combination of drugs which gives best pain relief after surgery |
|
Scientific Title of Study
|
A comparison of postoperative analgesic efficacy between Dexmeditomidine with Levobupivacaine versus Dexmeditomidine with Ropivacaine in Ultrasound guided Transversus Abdominal block for total abdominal hysterectomy surgeries- A double blinded 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 |
Madhubalan Manivannan |
| Designation |
Post Graduate |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Shri Sathya Sai Medical College and Research Institute, Thiruporur-Guduvancherry Main Road,Ammapettai, Kancheepuram District, Nellikuppam
Shri Sathya Sai Medical College and Research Institute, Thiruporur-Guduvancherry Main Road,Ammapettai, Kancheepuram District, Nellikuppam
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
8056985557 |
| Fax |
|
| Email |
mdocr.9500@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anusha Balasubramanian |
| Designation |
Associate Professor |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Shri Sathya Sai Medical College and Research Institute, Thiruporur-Guduvancherry Main Road,Ammapettai, Kancheepuram District, Nellikuppam
Shri Sathya Sai Medical College and Research Institute, Thiruporur-Guduvancherry Main Road,Ammapettai, Kancheepuram District, Nellikuppam
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9003738506 |
| Fax |
|
| Email |
anusha14scorpio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Madhubalan Manivannan |
| Designation |
Post Graduate |
| Affiliation |
Shri Sathya Sai medical College and research institute |
| Address |
Department of Anaesthesiology, Shri Sathya Sai Medical College and Research Institute, Thiruporur-Guduvancherry Main Road,Ammapettai, Kancheepuram District, Nellikuppam
Shri Sathya Sai Medical College and Research Institute, Thiruporur-Guduvancherry Main Road,Ammapettai, Kancheepuram District, Nellikuppam
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
8056985557 |
| Fax |
|
| Email |
mdocr.9500@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Shri Sathya Sai Medical College and Research Institute,
Thiruporur, Guduvancherry Main Road, Ammapettai, Nellikuppam, Kancheepuram, 603108, Tamil
Nadu, India |
|
|
Primary Sponsor
|
| Name |
M Madhubalan |
| Address |
SHRI SATHYA SAI MEDICAL COLLEGE AND RESEARCH INSTITUTE THIRUPORUR GUDUVANCHERRY MAIN ROAD CHENGALPAT TALUK AMMAPETTAI , KANCHEEPURAM DISTRICT
|
| 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 Madhubalan Manivannan |
Shri Sathya Sai medical college and research institute |
First Floor OT Complex, Department of Anaesthesiology, Shri Sathya Sai Medical College and Research Institute,
Thiruporur, Guduvancherry Main Road, Ammapettai, Nellikuppam, Kancheepuram, 603108, Tamil
Nadu, India district, Nellikuppam , Tamilnadu- 603108
Kancheepuram
TAMIL NADU |
8056985557
mdocr.9500@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL HUMAN ETHICAL COMMITTEE |
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
Dexmedetomidine |
O.25% Levobupivacaine 10 mL mixed with Dexmedetomidine 50 mcg given as TAP block post surgery
DURATION - POD 0 - POD 2 |
| Comparator Agent |
Ropivacaine
Dexmedetomidine |
0.25% Ropivacaine 10 mL mixed with Dexmedetomidine 50 mcg given as TAP block post surgery
POD 0 To POD 02 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Adult patients between 18 to 60 years of both sexes
Patients belonging to ASA CLASS 1 to ASA CLASS 2 posted for elective lower abdominal hysterectomy surgeries
Weight from 50 to 80 kgs |
|
| ExclusionCriteria |
| Details |
Patient refusal for regional anaesthesia.
Pregnancy and lactating female.
Obese patients.
Patience with ASA class three and four.
Patient is allergic to local anaesthetics and Dexmeditomidine. Patient is having local site infection.
Patients having any bleeding Coagulopathy disorders. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The duration of Analgesia in post-operative period between the two groups. It will be measure with parameters such as VAS score , BLOOD PRESSUE , PULSE RATE . |
Post operative day 0 to Post operative day 02 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To monitor heart rate, BLOOD PRESSURE, SPO2 , VAS SCORE from the time of TAP block to the time of break through pain.
To monitor for complications, if any, from the time of tap block to the time of breakthrough pain |
Postoperative period ( POD 0 to POD 02 ) - From the End of Surgery to the period of Patient getting medication for pain . |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
25/12/2024 |
| 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 Yet Recruiting |
| 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
|
COMPARISON OF POST OPERATIVE ANALGESIC EFFICACY BETWEEN DEXMEDETOMIDINE WITH LEVOBUPIVACAINE VERSUS DEXMEDITOMIDINE WITH ROPIVACAINE IN ULTRASOUND GUIDED TRANSVERSUS ABDOMINAL BLOCK FOR TOTAL ABDOMINAL HYSTERECTOMY SURGERIES
Primary objective: The duration of Analgesia in post-operative period between the two groups. Secondary objective: To monitor heart rate, BP, SPO2 from the time of TAP block to the time of break through pain. To monitor for complications, if any, from the time of tap block to the time of breakthrough pain . |