| CTRI Number |
CTRI/2024/02/062952 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparative Study Of USG Guided Versus Peripheral Nerve Stimulator guided Nerve block For Post Operative Analgesia in inguinal hernia surgeries |
|
Scientific Title of Study
|
A Comparative Study of USG Guided Versus Peripheral Nerve Stimulator guided Ilioinguinal and Iliohypogastric nerve block for Post operative Analgesia in Inguinal Hernia Surgries |
| 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 Swapnil Niraj Desai |
| Designation |
Junior Resident |
| Affiliation |
MGM Medical College and Hospital Aurangabad |
| Address |
Department of Anaesthesiology
3rd floor
MGM Medical College and Hospital
N 6 CIDCO
Department of Anaesthesiology
3rd floor
MGM Medical College and Hospital
N 6 CIDCO
Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9757407372 |
| Fax |
|
| Email |
swapnil.desai12@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanhita J Kulkarni |
| Designation |
Professor |
| Affiliation |
MGM Medical College and Hospital Aurangabad |
| Address |
Department of Anaesthesia MGM Medical College and Hospital Aurangabad N 6 CIDCO
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9881300645 |
| Fax |
|
| Email |
drsanhitakulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanhita J Kulkarni |
| Designation |
Professor |
| Affiliation |
MGM Medical College and Hospital Aurangabad |
| Address |
Department of Anaesthesia MGM Medical College and Hospital Aurangabad N 6 CIDCO
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9881300645 |
| Fax |
|
| Email |
drsanhitakulkarni@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Medical College and Hospital Aurangabad |
|
|
Primary Sponsor
|
| Name |
MGM Medical College and Hospital |
| Address |
MGM Medical College and Hospital N 6 CIDCO Aurangabad
431003 |
| 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 Swapnil Niraj Desai |
MGM Medical College and Hospital |
Department of Anaesthesiology
3rd floor
MGM Medical College and Hospital Aurangabad
Aurangabad
MAHARASHTRA |
9757407372
swapnil.desai12@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Missions Ethics Committee for Research on Human Subjects |
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 |
| Comparator Agent |
Peripheral nerve stimulator guided ilioinguinal and iliohypogastric nerve block for post operative analgesia |
Group P: 30 patients
Drug: 20 ml of 0.25% inj. Ropivacaine plus 4mg inj. Dexamethasone
Route of administeration: percutaneously through the anterior abdominal wall using 50mm stimuplex needle using peripheral nerve stimulator guided technique.
Time taken for procedure will be measured.
Duration of the study: 2 years. |
| Intervention |
USG guided ilioinguinal and iliohypogastric nerve block for post operative analgesia |
Group U: 30 patients
Drug: 20 ml of 0.25% inj. Ropivacaine plus 4mg inj. Dexamethasone
Route of administration: percutaneously through the anterior abdominal wall using 50mm stimuplex needle using USG guided technique.
Time taken for procedure will be measured.
Duration of the study: 2 years. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1,2,3 patients
Elective unilateral open inguinal hernia surgery under spinal anaesthesia
Patients giving consent for procedure |
|
| ExclusionCriteria |
| Details |
Patients with allergy to local anaesthetics
Contraindications to spinal anaesthesia
Severe hepatic or renal disease
Ejection fraction <30%, valvular heart disease.
|
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| compare the duration of post operative analgesia after hernia surgeries in usg guided and peripheral nerve stimulator guided groups. |
Assessment of post operative analgesia for 24 hours after administration of the nerve block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the time taken for performig the nerve block using usg guided and peripheral nerve stimulator guided technique and the total number of analgesics consumed within 24 hours |
Assessment of duration of the procedure on table and number of analgesics consumed in 24 hours |
|
|
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 4 |
|
Date of First Enrollment (India)
|
04/03/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Inguinal hernia repair is one of the most common surgeries performed and immediate post operative pain is an important issue associated with the surgery. Acute pain is a reaction to tissue injury, viscera distension and disease. Despite the availability of effective analgesics, 30-70% patients suffer from post operative pain. Immediate post operative pain can result in delay in ambulation, return of gastrointestinal motility and thus discharge from the hospital. Also some patients can land up in chronic pain. Peripheral nerve blocks like the Ilioinguinal nerve and the Iliohypogastric nerve block are effective regional anaesthetic technique in hernia surgeries with good analgesia and minimal side effects. For inguinal hernia surgeries, the most common nerves that are involved in peripheral nerve blockade are the Ilioinguinal Nerve and the Iliohypogastric nerve. These nerves are blocked in the plane between the Transverses Abdominis and Internal Oblique muscles. The approach to these blocks is by landmark, peripheral nerve stimulator guided technique or by USG guided nerve blocks. The failure rate of landmark technique is 45-72%. USG guided blocks can increase the success rates due to real time visualisation of underlying structures and the needle tip. Peripheral nerve stimulators have easy accessibility, easy to use and inexpensive.
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