| CTRI Number |
CTRI/2022/12/048567 [Registered on: 28/12/2022] Trial Registered Prospectively |
| Last Modified On: |
29/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
which nerve block provide better pain free time after caesarean section |
|
Scientific Title of Study
|
Comparison between Ultrasound guided Transversus abdominis plane block versus Ilioinguinal/ Iliohypogastric nerve block for post operative analgesia in cesarean section. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kalicharan kisku |
| Designation |
PG RESIDENT |
| Affiliation |
VIMSAR; BURLA |
| Address |
Department of anasthesiology and critical care VIMSAR BURLA
SAMBALPUR
Sambalpur
ORISSA
768017
India |
| Phone |
7008904214 |
| Fax |
|
| Email |
kiskukalicharan25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr BIMAL KRUSHNA PANDA |
| Designation |
PROFESSOR |
| Affiliation |
VIMSAR; BURLA |
| Address |
Department of anasthesiology and critical care VIMSAR BURLA SAMBALPUR
Sambalpur
ORISSA
768017
India |
| Phone |
9437175425 |
| Fax |
|
| Email |
drbimalpanda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalicharan kisku |
| Designation |
PG RESIDENT |
| Affiliation |
VIMSAR; BURLA |
| Address |
Department of anasthesiology and critical care VIMSAR BURLA SAMBALPUR
Sambalpur
ORISSA
768017
India |
| Phone |
7008904214 |
| Fax |
|
| Email |
kiskukalicharan25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology VIMSAR BURLA sambalpur 768017 |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology |
| Address |
Vimsar Burla Odisha 768017 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sheela Ekka |
Department Of Anasthesiology and Critical Care Vimsar Burla |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kalicharan Kisku |
VIMSAR BURLA |
Department of Anesthesiology
room no 42
Sambalpur
ORISSA |
7008904214
kalicharankisku25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL RESEARCHAND ETHICS COMMITTEE, VIMSAR,BURLA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, (2) ICD-10 Condition: 1||Obstetrics, (3) ICD-10 Condition: O420||Premature rupture of membranes, onset of labor within 24 hours of rupture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ilioinguinal iliohypogastric nerve block |
ropivacaine. 25 % ,
20ml
|
| Intervention |
Transversus abdominis plane block |
ropivacaine 0.25%, 20ml on each side,10 minutes |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
patients planned for LSCS under SAB
ASA grade 2 |
|
| ExclusionCriteria |
| Details |
patient refusal
failed and partial block
block site infection
bleeding disorders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the rescue analgesia requirement in 24hrs postoperatively between both group. |
To compare the rescue analgesia requirement in 24hrs postoperatively between both group. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
NRS SCORE
time of rescue analgesic
Nausea
vomiting |
2 hr
8hr
16hr
24hr |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
05/01/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The dose of analgesia requirement is less in ilioinguinal iliohypogastric block. so having similar analgesic efficacy to transversus abdominis plane block
|