| CTRI Number |
CTRI/2024/05/066915 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
05/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To study different nerve block for postoperative pain releif in unilateral inguinal hernia surgeries. |
|
Scientific Title of Study
|
Comparison of ultrasound guided transversus abdominis plane block vs ilioinguinal/iliohypogastric nerve block vs quadratus lumborum block for postoperative analgesia in unilateral inguinal hernia surgeries-randomized controlled 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 |
Shareefa Akhtar |
| Designation |
Postgraduate |
| Affiliation |
Sri Manakula Vinayagar Medical Colledge And Hospital |
| Address |
Room number 109
First floor
Department of anesthesia
Sri Manakula Vinayagar Medical Colledge And Hospital
Department Of Anaesthesiology
Kalitheerthalkuppam
Madagadipet
Pondicherry
PONDICHERRY
605107
India |
| Phone |
7598138343 |
| Fax |
|
| Email |
akhtarshareefa27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dilip Chandar |
| Designation |
Professor |
| Affiliation |
Sri Manakula Vinayagar Medical Colledge And Hospital |
| Address |
Room number 109
First floor
Department of anesthesiaSri Manakula Vinayagar Medical Colledge And Hospital
Department Of Anaesthesiology
Kalitheerthalkuppam
Madagadipet
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9993031202 |
| Fax |
|
| Email |
dilipchandar2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dilip Chandar |
| Designation |
Professor |
| Affiliation |
Sri Manakula Vinayagar Medical Colledge And Hospital |
| Address |
Room number 109
First floor
Department of anesthesiaSri Manakula Vinayagar Medical Colledge and Hospital
Department Of Anaesthesiology
Kalitheerthalkuppam
Madagadipet
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9993031202 |
| Fax |
|
| Email |
dilipchandar2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Manakula Vinayagar Medical Colledge and Hospital
Department Of Anaesthesiology
Kalitheerthalkuppam
Madagadipet 605107
Pondicherry
India |
|
|
Primary Sponsor
|
| Name |
shareefa akhtar |
| Address |
sri manakula vinayagar medical colledge and hospital
department of anaesthesiology
kalitheerthalkuppam
madagadipet
605107 |
| 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 |
| shareefa akhtar |
Sri Manakula Vinayagar Medical Colledge and Hospital |
Room number 109
First floor
Department Of Anaesthesiology
Speciality OT
Roon Number 108
Pondicherry
PONDICHERRY |
7598138343
akhtarshareefa27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Manakula Vinayagar Medical Colledge And Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ilioinguinal/iliohypogastric nerve block |
ilioinguinal/iliohypogastric nerve block given with 0.25% levobupivacaine 20ml |
| Comparator Agent |
Quadratus lumborum block |
Quadratus lumborum block given with 0.25% levobupivacaine 20 ml |
| Intervention |
Transversus abdominis plane block |
Transversus abdominis plane block given with 0.25% of levobupivacaine 20ml |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
adult patient undergoing elective unilateral inguinal hernia surgeries
ASA physical status I II |
|
| ExclusionCriteria |
| Details |
Patients refusal to participate in the study
Patients with recurrent inguinal hernia with known hypersensitivity to local anaesthesia
Patient with major comorbidities such as severe cardiorespiratory illness
Morbid obesity renal ailments coagulopathy and seizures disorder |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare ultrasound guided transversus abdominis block ilioinguinal/iliohypogastric nerve block and quadratus lumborum block in terms of duration of analgesia |
minutes and hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the ease of performance of each technique |
no of attempts |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/06/2024 |
| 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 - NO
|
|
Brief Summary
|
Open inguinal hernia surgery is one of the commonly performed surgical procedures which is associated with postoperative pain and distress. One of the best approach for post op analgesia is peripheral nerve block. It provide safe and effective post op pain management.It has decreased recovery time by minimizing the side effects like nausea vomiting drowsiness and also delays the time of first analgesic requirement. Transversus abdominis plane block ilioinguinal/iliohypogastric nerve block and quadratus lumborum block are three techniques that provide excellent postoperative analgesia for elective unilateral inguinal hernia surgeries.Though individually studied and proved efficacy they are not compared all three techniques.So we designed this study to compare all the three techniques in terms of postoperative analgesia.We will be administering 0.25% LEVO BUPIVACAINE 20 ml in three of the techniques.The study population will be selected according to inclusion and exclusion criteria.Those who fulfills the criteria will be eligible to participate in the study.The patient and attenders will be explained about the procedure and how to give response during the study.After obtaining consent participants will be recruited to study.As per plan of study an experienced anaesthesiologist will be administering block at end of the surgery and block performance time will be recorded.She/he will be monitored for next 24 hours for the duration of analgesia.As the procedure done under USG guidance occurrence of complication is extremely minimal however we will be prepared for the same.At the end of the study we hope we will be able to come to conclusion wheather transversus abdominis plane block or ilioinguinal/iliohypogastric nerve block or quadratus lumborum block provide better analgesia and hence can be used for the improved patient care.
|