| CTRI Number |
CTRI/2021/09/036352 [Registered on: 08/09/2021] Trial Registered Prospectively |
| Last Modified On: |
07/09/2021 |
| 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
|
Comparison of TAP block & IL/IH block in Inguinal Hernia Repair patients. |
|
Scientific Title of Study
|
Comparative efficacy of postoperative pain relief between ultrasound guided Transversus abdominis plane block and Ilioinguinal & Iliohypogastric nerve blocks for patients undergoing open inguinal hernia repair under Spinal Anaesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VADDADI RAVITEJ |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
IMS AND SUM HOSPITAL |
| Address |
Department of Anaesthesia, 1st floor, IMS AND SUM HOSPITAL, SECTOR 8, KALINGA NAGAR, BHUBANESWAR, ODISHA.
Khordha
ORISSA
751003
India |
| Phone |
7799512333 |
| Fax |
|
| Email |
ravitejvaddadi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SWARNA BANERJEE |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
IMS AND SUM HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIA, 1ST FLOOR, IMS AND SUM HOSPITAL, SECTOR 8, KALINGA NAGAR, BHUBANESWAR, ODISHA
Khordha
ORISSA
751003
India |
| Phone |
7799512333 |
| Fax |
|
| Email |
swarnabanerjee@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
VADDADI RAVITEJ |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
IMS AND SUM HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIA, 1ST FLOOR, IMS AND SUM HOSPITAL, SECTOR 8, KALINGA NAGAR, BHUBANESWAR, ODISHA
Khordha
ORISSA
751003
India |
| Phone |
7799512333 |
| Fax |
|
| Email |
ravitejvaddadi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
VADDADI RAVITEJ |
| Address |
DEPARTMENT OF ANAESTHESIA, IMS AND SUM HOSPITAL, SECTOR 8, KALINGA NAGAR, BHUBANESWAR, ODISHA. 751003 |
| 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 |
| VADDADI RAVI TEJ |
IMS AND SUM HOSPITAL |
MODULAR OT COMPLEX,1ST FLOOR, DEPARTMENT OF ANAESTHESIA,SECTOR 8,KALINGA NAGAR, BHUBANESWAR, ODISHA 751003 .
Khordha
ORISSA |
7799512333
ravitejvaddadi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional Ethics Committee , IMS AND SUM 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 |
Spinal anaesthesia |
drug - 0.5% heavy bupivacaine
dosage - 3.2 ml
spinal needle - 25G size |
| Comparator Agent |
Spinal Anaesthesia plus Ilioinguinal/Iliohypogastric nerve block |
drug - 0.2% ropivacaine, dosage 20ml. |
| Comparator Agent |
Spinal Anaesthesia plus Transversus Abdominis plane block |
drug - 0.2% ropivacaine, dosage 20ml. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
AGE - 18 TO 60 Years.
ASA Physical status grade - I and II.
Patients undergoing elective primary unilateral open
inguinal hernia repair.
|
|
| ExclusionCriteria |
| Details |
Patient who refused to consent to study.
BMI > 40 kg/m2
Poorly regulated systemic diseases.
Local infection at the site of block.
Patients with neuromuscular diseases.
Patients with hypersensitivity to local
anaesthetic drugs.
Patients who will be scheduled for bilateral or
recurrent inguinal hernia repair.
|
|
|
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 |
| comparision of duration of post operative analgesia |
48hrs post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compare quality of pain relief |
upto 48hrs postoperatively |
| requirement of rescue analgesia |
upto 48hrs postoperatively |
| incidence of any side effects |
upto 48hrs postoperatively |
|
|
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)
|
23/09/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a Randomized, double blind, parallel group trail comparing the efficacy of postoperative pain relief between ultrasound guided transversus abdominis plane block and ilioinguinal plane & iliohypogastric nerve block in patients undergoing open inguinal hernia repair under spinal anaesthesia. This trial will be conducted in 60 patients with ASA grades I & II in India. The primary outcome is to measure and compare the duration of postoperative analgesia. Secondarily, to compare the quality of pain relief and requirement of rescue analgesia for the first 48 hours post operatively. |