| CTRI Number |
CTRI/2023/07/055537 [Registered on: 24/07/2023] Trial Registered Prospectively |
| Last Modified On: |
22/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To assess the efficacy of dexmedetomidine and levobupivacaine in tap block for Post operative pain |
|
Scientific Title of Study
|
A comparative evaluation of Efficacy of 0.5% levobupivacaine Versus 0.5% levobupivacaine with dexmedetomidine in Ultrasound guided transversus abdominis plane block for Post operative analgesia in patients undergoing abdominal surgeries |
| 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 Priyesh Bhaskar |
| Designation |
Professor and Head of the Department of Anesthesiology |
| Affiliation |
Career institute of medical science and hospital |
| Address |
Resident room number - 1
Division -1st
Department of Anaesthesia
Career Institute of medical sciences and Hospital IIM road Ghaila
Lucknow
UTTAR PRADESH
226013
India |
| Phone |
7985975077 |
| Fax |
|
| Email |
Dr.priyeshlpsc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyesh Bhaskar |
| Designation |
Professor and Head of the Department of Anesthesiology |
| Affiliation |
Career institute of medical science and hospital |
| Address |
Resident room number - 1
Division -1st
Department of Anaesthesia
Career Institute of medical sciences and Hospital IIM road Ghaila
Lucknow
UTTAR PRADESH
226013
India |
| Phone |
7985975077 |
| Fax |
|
| Email |
Dr.priyeshlpsc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varun Sharma |
| Designation |
PG junior resident |
| Affiliation |
Career institute of medical science and hospital |
| Address |
Anaesthesia Resident room, Department of Anaesthesia, Career Institute of medical sciences and Hospital Iim road ghailla Lucknow
Lucknow
Lucknow
UTTAR PRADESH
226013
India |
| Phone |
7814142102 |
| Fax |
|
| Email |
anvpks0594@gmail.com |
|
|
Source of Monetary or Material Support
|
| Career institute of medical science and hospital, Lucknow |
|
|
Primary Sponsor
|
| Name |
Career institute of medical science and hospital |
| Address |
Iim road, Lucknow, Uttar Pradesh |
| 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 |
| Dr Priyesh Bhaskar |
Career institute of medical science and hospital |
Resident room number - 1 Division -1st Department of Anaesthesia
Lucknow
UTTAR PRADESH
Lucknow
UTTAR PRADESH |
7985975077
drpriyeshlpsc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Career Institute of Medical Sciences and Hospital, Lucknow |
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 |
| Comparator Agent |
Comparative evaluation of 0.5% Levobupivacaine in TAP BLOCK |
A Comparative evaluation of Efficacy of 0.5% levobupivacaine 20ml(100mg) Versus 0.5% levobupivacaine 20ml (100mg) with dexmedetomidine 0.5 mcg/kg in Ultrasound guided transversus abdominis plane block for Post operative analgesia in patients undergoing abdominal surgeries
frequency route of administration is parenteral route
total duration of such intervention will take 10 minutes |
| Intervention |
Transverse abdominus plane block in abdomen surgery |
A Comparative evaluation of Efficacy of 0.5% levobupivacaine Versus 0.5% levobupivacaine with dexmedetomidine in Ultrasound guided transversus abdominis plane block for Post operative analgesia in patients undergoing abdominal surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I/II belonging to American Society of Anaesthesiologists (ASA)
Age group 18 to 65 years
Patient undergoing abdominal surgeries under general anesthesia/spinal anesthesia will enrolled in the study
Patient willing to give consent |
|
| ExclusionCriteria |
| Details |
Patients with history of :
Allergy to LEVOBUPIVACAINE
Body mass index >35 kg.m−2
Preoperative opioid or nonsteroidal anti-inflammatory drug treatment for chronic pain.
Morbid obesity
Cardiac disorders - ischaemic heart disease, hypertension
Renal dysfunction - chronic renal failure,acute kidney disease.
Pre-existing neurological deficits,psychiatric illness will be excluded from the study.
If the laparoscopic surgery will be switched to open procedure, the patient will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Onset & duration of Sensory blockade
Duration of post operative analgesia
Visual analogue score |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Postoperative rescue analgesic requirement
Side effects or complications |
18 months |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2023 |
| 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 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [anvpks0594@gmail.com].
- For how long will this data be available start date provided 15-07-2023 and end date provided 17-06-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
A comparative evaluation of Efficacy of 0.5% levobupivacaine Versus 0.5% levobupivacaine with dexmedetomidine in Ultrasound guided transversus abdominis plane block for Post operative analgesia in patients undergoing abdominal surgeries |