| CTRI Number |
CTRI/2025/01/079528 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ultrasounn guided peripheral nerve block with local anaesthetics for postoperative analgesia in laparoscopic abdominal suergeries |
|
Scientific Title of Study
|
Ultrasound Guided Trans versus Abdominis Plane Block With Levobupivacaine And Ropivacaine For Postoperative Analgesia In Laproscopic Abdominal Surgeries Under General Anesthesia In Tertiary Care Hospital:A Comparative Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
pujari prathibha rani |
| Designation |
|
| Affiliation |
GAYATRI VIDYA PARISHAD INSTITUTE OF HEALTH CARE AND MEDICAL TECHNOLOGY |
| Address |
department of anaesthesiology,6-25,maridi valley,marikavalasa,madhurwada,visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530048
India |
| Phone |
9989638549 |
| Fax |
08912590131 |
| Email |
pratibhapujari79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
thottikat kaarthika |
| Designation |
assistant professor |
| Affiliation |
GAYATRI VIDYA PARISHAD INSTITUTE OF HEALTH CARE AND MEDICAL TECHNOLOGY |
| Address |
department of anaesthesiology,6-25,maridi valley,marikavalasa,madhurwada,visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530048
India |
| Phone |
9908888134 |
| Fax |
08912590131 |
| Email |
karthika.mohan07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
thottikat kaarthika |
| Designation |
assistant professor |
| Affiliation |
GAYATRI VIDYA PARISHAD INSTITUTE OF HEALTH CARE AND MEDICAL TECHNOLOGY |
| Address |
department of anaesthesiology,6-25,maridi valley,marikavalasa,madhurwada,visakhapatnam
Visakhapatnam
ANDHRA PRADESH
530048
India |
| Phone |
9908888134 |
| Fax |
08912590131 |
| Email |
karthika.mohan07@gmail.com |
|
|
Source of Monetary or Material Support
|
| GAYATRI VIDYA PARISHAD INSTITUTE OF HEALTH CARE AND MEDICAL
TECHNOLOGY
department of anaesthesiology,6-25,maridi valley,marikavalasa,madhurwada,visakhapatnam-530048
|
|
|
Primary Sponsor
|
| Name |
GAYATRI VIDYA PARISHAD INSTITUTE OF HEALTH CARE AND MEDICAL TECHNOLOGY |
| Address |
6-25,Maridi valley,Marikavalasa,Madhurawada,Visakhapatnam 530048 |
| 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 manjula v ramsali |
GAYATRI VIDYA PARISHAD INSTITUTE OF HEALTH CARE AND MEDICAL TECHNOLOGY |
Department of anesthesiology,6-25, Maridi valley,Marikavalasa,Madhurwada,Visakhapatnam-530048
Visakhapatnam
ANDHRA PRADESH |
9989335429
08912590131
manjularamsali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee GVPIHCMT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K358||Other and unspecified acute appendicitis, (2) ICD-10 Condition: Z302||Encounter for sterilization, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound Guided Transversus Abdominis Plane Block |
Ultrasound Guided Transversus Abdominis Plane Block with Levobupivacaine for post operative analgesia |
| Comparator Agent |
Ultrasound Guided Transversus Abdominis Plane Block |
Ultrasound Guided Transversus Abdominis Plane Block with Ropivacaine for post operative analgesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients taken for surgeries: elective abdominal laparoscopic surgeries
(laparoscopic tubectomies, cystectomies, appendectomies, hernioplasty)
under general anaesthesia.
|
|
| ExclusionCriteria |
| Details |
Patients who are allergic to study drugs.
Patients having severe cardiac, pulmonary and renal diseases.
Patients in whom abdominal drain is kept.
Patients who are unwilling to participate in the study.
Pregnant and lactating women.
Patients who do not satisfy inclusion criteria
Patients with coagulopathy.
Patients who are unable to give informed consent.
Patients who cannot understand VAS score.
Patients who are converted to open surgery
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Magnitude of pain assessed by visual analogue score (VAS). |
30minutes, 1st, 2nd, 4th,
6th, 8th,12th,24 hours post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to first analgesia request. |
first 24 hours post surgery |
Adverse effects like bradycardia, hypotension, nausea, vomiting and
respiratory depression |
first 24hours post surgery |
| analgesic requirement |
first 24hours post surgery |
| patient satistfaction |
24 hours post surgery |
|
|
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 3 |
|
Date of First Enrollment (India)
|
01/02/2025 |
| 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="3"
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- 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 - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rxpg.dr@gmail.com].
- For how long will this data be available start date provided 21-12-2024 and end date provided 31-01-2025?
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
|
we intent the compare the analgesic efficacy of 0.2% levobupivacaine and 0.2% ropivacaine in ultrasound guided transversus abdominis plane block in patients undergoing laparoscopic abdominal surgeries |