| CTRI Number |
CTRI/2025/02/081200 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to compare the effects of two different pain management techniques for control of pain after groin surgeries. |
|
Scientific Title of Study
|
Ultrasound guided llioinguinal/llio-hypogastric nerve block vs transverse abdominis plane block for pain management following inguinal hernia repair surgery:A randomised clinical 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 |
Dr Neeraj Badyal |
| Designation |
Senior Resident, Department of anesthesiology |
| Affiliation |
Government Medical College Kathua |
| Address |
Department of Anaesthesiology and critical care GMC Kathua, Kathua, Jammu and
Kashmir, India
Kathua
JAMMU & KASHMIR
184101
India
Kathua
JAMMU & KASHMIR
184101
India |
| Phone |
8082180526 |
| Fax |
|
| Email |
neerajbadyal51@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Angral |
| Designation |
Associate Professor , Department of Anaesthesiology |
| Affiliation |
Government Medical College Kathua |
| Address |
Department of Anaesthesiology and critical care, GMC Kathua,,Jammu and
Kashmir,India
Kathua
JAMMU & KASHMIR
184101
India
Kathua
JAMMU & KASHMIR
184101
India |
| Phone |
7006047500 |
| Fax |
|
| Email |
rajeshangral73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Angral |
| Designation |
Associate Professor , Department of Anaesthesiology |
| Affiliation |
Government Medical College Kathua |
| Address |
Department of Anaesthesiology and critical care, GMC Kathua,,Jammu and
Kashmir,India
Kathua
JAMMU & KASHMIR
184101
India
Kathua
JAMMU & KASHMIR
184101
India |
| Phone |
7006047500 |
| Fax |
|
| Email |
rajeshangral73@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College Kathua, district Kathua,Jammu and Kashmir, India pin:184101 |
|
|
Primary Sponsor
|
| Name |
Dr Neeraj Badyal |
| Address |
Senior Resident , Department of Anesthesia and critical care GMC kathua, district
Kathua, Jammu and kasmir, India pin 184101 |
| Type of Sponsor |
Government 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 Rajesh Angral |
Hospital, Government Medical College Kathua |
Department of Anaesthesiology and
critical care, GMC Kathua, district
Kathua, Jammu and Kashmir, India,
pin 184102
Kathua
JAMMU & KASHMIR
Kathua
JAMMU & KASHMIR |
7006047500
rajeshangral73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Govt. Medical College Kathua |
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 |
Transversus abdominis plane block (TAP)and ilioinguinal / iliohypogastric plane (IIIH) block. |
Usg guided TAP block , interfacial plane block given between internal oblique and transversus abdominis muscle at the triangle of petit
and Usg guided IIIH block given into the fascia plane between the
internal oblique and transversus abdominis muscles 2.5 cm medial to anterior superior iliac spine (ASIS) and 1 cm cephalad to reference line connecting umblicus and ASIS. |
| Comparator Agent |
Usg guided TAP block and IIIH block. |
The TAP group will receive 20 ml of total volume of drug
containing 16mL of local anaesthetic levobupivacaine hydrochloride
0.25% + 12mg of adenosine (4ml) and the IIIH group will
receive the same composition of the drug . Here two techniques
will be compared. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) patients between age group of 18 years to 60years who are undergoing inguinal
hernia repair in elective OT
2) ASA class 1 & 2
3) patients who are willing to participate and provide a willing written informed consent. |
|
| ExclusionCriteria |
| Details |
1) patients with any chronic medical illness
2) history of any bleeding disorders
3) patients allergic to any of these drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Severity of pain using Visual Analogue Scale (VAS)
2) Time to 1st request of analgesia |
1) Severity of pain using Visual Analogue Scale (VAS) at 1,2,6,12 and 24 hrs of surgery.
2) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Total number of analgesic doses of opioids and NSAIDS in 24 hours following
surgery
2) side effects like nausea, vomiting and shivering |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/03/2025 |
| 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="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
|
This study is a randomised, parallel group, clinical trial comparing the effectiveness of two blocks i.e ultrasound guided transversus abdominis plane block versus ilioinguinal/ iliohypogastric block for postoperative analgesia in patients undergoing inguinal surgeries, as measured by duration of analgesia and pain score in 24 hours following surgery. The primary outcome of the study is to record the severity of pain using Numerical rating scale and time to request of first analgesia i.e the time elapsed between the end of surgery to 1st dose of analgesia. The secondary outcome is to see the total no. of analgesic doses of opioids and NSAIDs in 24 hours following surgery and to see any side effects like nausea, vomiting and shivering occurring after the procedure. |