| CTRI Number |
CTRI/2025/02/080921 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
14/02/2025 |
| 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
|
A study to compare Ilioinguinal-Iliohypogastric Nerve Block and Transversus Abdominis Plane Block for post operative pain relief in open Inguinal Hernia Repair |
|
Scientific Title of Study
|
Ultrasound Guided Ilioinguinal-Iliohypogastric Nerve Block Versus Ultrasound Guided Transversus Abdominal Plane Block for Post-Operative Analgesia in Open Inguinal Hernia Repair: A Randomised 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 |
Bhagyashri Nemade |
| Designation |
Junior Resident |
| Affiliation |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
| Address |
Department of Anaesthesiology, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Hingna Road, Nagpur
Nagpur MAHARASHTRA 440019 India |
| Phone |
9503381609 |
| Fax |
|
| Email |
bhagyashrinemade.9503@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Heena Pahuja |
| Designation |
Professor |
| Affiliation |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
| Address |
Department of Anaesthesiology, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Hingna Road, Nagpur
Nagpur MAHARASHTRA 440019 India |
| Phone |
9823188160 |
| Fax |
|
| Email |
heenapahuja15@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Bhagyashri Nemade |
| Designation |
Junior Resident |
| Affiliation |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
| Address |
Department of Anaesthesiology, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Hingna Road, Nagpur
Nagpur MAHARASHTRA 440019 India |
| Phone |
9503381609 |
| Fax |
|
| Email |
bhagyashrinemade.9503@gmail.com |
|
|
Source of Monetary or Material Support
|
| NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
|
|
Primary Sponsor
|
| Name |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
| Address |
Department of Anaesthesiology, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Hingna Road, Nagpur |
| 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 Bhagyashri Nemade |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital |
4th Floor, Department of Anaesthesiology, NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital, Hingna Road, Nagpur Nagpur MAHARASHTRA |
9503381609
bhagyashrinemade.9503@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee N.K.P Salve Institute of Medical Sciences and Research Center and Lata Mangeshkar Hospital, Nagpur |
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 |
Ilioinguinal Iliohypogastric Nerve Block |
Inj Ropivacaine 0.25% 10 cc given unilaterally on the side of surgery. The time of block will be taken as 0 hr |
| Comparator Agent |
Transversus Abdominis Plane Block |
Inj Ropivacaine 0.25% 20cc given unilaterally on the side of surgery. The time of block will be taken as 0 hr |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
1. Patient undergoing unilateral inguinal hernia surgeries under subarachnoid block
2. American Society of Anaesthesiology (ASA) physical status I,II, III
3. BMI less than 30 Kg/m2 |
|
| ExclusionCriteria |
| Details |
1. H/o allergy to local anaesthetics.
2. Infection around the block site.
3. Patient’s Refusal.
4. Coagulopathy.
5. Chronic opioid use.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare Ultrasound Guided Ilioinguinal- Iliohypogastric nerve block versus Ultrasound Guided Transversus Abdominis Plane block for post-operative analgesia in open inguinal hernia repair in terms of:
Numerical Rating Score for pain assessment
Time of first rescue analgesia
Total analgesic requirement in first 24 hrs.
|
Time of block will be taken as 0 hrs.
Patient will be analysed for the above points at 1, 2, 3, 4, 6, 8, 12, 24 hrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison of the complications of Ultrasound Guided Ilioinguinal-Iliohypogastric nerve block and Transverse Abdominis Plane block for post operative analgesia in open inguinal hernia repair with respect to:
1] Vascular puncture
2] Haematoma
|
Time of block will be taken as 0 hrs.
Patient will be analysed for the above points at 1, 2, 3, 4, 6, 8, 12, 24 hrs. |
|
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
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 3 |
|
Date of First Enrollment (India)
|
26/02/2025 |
| 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="1" Months="6" 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
|
Open Inguinal Hernia surgery is one of the most commonly performed procedures across the world and is associated with about 60 percent moderate to severe post operative pain. This acute postoperative pain without adequate analgesia may lead to persistent postsurgical pain. The incidence of chronic postsurgical pain varies according to surgeries and is 5 percent to 35 percent in hernia surgery. For management of pain, in post operative hernia repair, various treatment modalities have been advocated. Most of them have been proved inconsistent. Despite of providing good analgesia, Opioids and NSAIDs are associated with several undesirable side effects. The major goal in the management of post-operative pain is to use minimal dose of medications to decrease their side effects. Regional nerve block techniques offer a great degree of post-operative pain relief thus facilitating early ambulation and discharge. Transversus abdominis plane contains intercostal nerves (T7-T11), subcostal nerves(T12), iliohypogastric and ilioinguinal nerves(L1) Transversus abdominis plane block [TAP] has been extensively used for post operative analgesia after inguinal hernia repair.TAP block being a compartment block provides analgesia to the parietal peritoneum and sensation to anterior and lateral abdominal wall in infra-umbilical surgeries block it requires larger volume. Ilioinguinal-iliohypogastric nerve block, blocks the branches of T12-L1 and provide effective analgesia in inguinal hernia surgeries. Local anaesthetic is deposited in the plane between the internal oblique and transverse abdominis muscle in both TAP and IIL/IH block, but at different points along the course of nerve , with local anaesthetic being administered closer to nerve in IIL/IH block. IIL/IH block being more precise requires lower volume of local anaesthetic and so lesser anaesthetic toxicity, complications and more simplicity and efficacy than TAP block to achieve similar analgesic effect. There are few studies comparing IIL/IH and TAP block for post oprerative analgesia for inguinal hernia repair but results are conflicting. Hence, we would like to propose a study for comparison of ultrasound guided IL/IH nerve block and ultrasound guided TAP block for open hernia repair for post operative analgesia.
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