- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06812741
Duration of Postop Analgesia After Inguinal Hernia Surgery Treated with TAP Block Vs II/IH Nerve Block
February 25, 2025 updated by: Kenan Anwar Khan, Pakistan Navy Station Shifa Hospital
Comparison of Mean Duration of Postoperative Analgesia in Patients Undergoing Inguinal Hernia Surgery Treated with Transversus Abdominal Plane Block Vs Ilioinguinal and Iliohypogastric Nerve Blocks
Comparing Postop Analgesia after Inguinal Hernia Surgery treated with TAP Block Vs Ilioinguinal/ Iliohypogastric Nerve Block
Study Overview
Status
Completed
Conditions
Detailed Description
Comparison of Mean Duration of Postoperative Analgesia in Patients undergoing Inguinal Hernia Surgery treated with Transversus Abdominal Plane Block Versus Ilioinguinal/ Iliohypogastric Nerve Block
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
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Lahore, Punjab, Pakistan
- Combined military hospital lahore
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients giving written informed consent
- Patients undergoing Inguinal Hernia surgery
- patients with ages 18-60 years
- ASA 1 and 2 patients
Exclusion Criteria:
- INR > 1.0 (patients with bleeding tendency)
- EF < 45 % (patients with cardiac dysfunction)
- FEV1 < 80 % of normal (patients with pulmonary dysfunction)
- patients with renal disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Inguinal Hernia Surgery (Group T)
Half of the study participants named Group T were administered Ultrasound Guided Transversus Abdominis Plane Nerve Block and the other half named Group I were administered Ilioinguinal & Iliohypogastric Nerve Block before the Inguinal Hernia Surgery.
|
The probe was placed in a plane transverse to the lateral abdominal wall in the mid-axillary line immediately cephalad to the iliac crest.
The needle was advanced immediately anterior to the probe using the in-plane needle-probe orientation and advanced posteriorly until the needle was observed to penetrate the interface between the internal oblique and transversus abdominis muscles.
Thereafter, a local anesthetic (0.2 mL/kg of 0.25 % bupivacaine) was injected incrementally, and the spread was observed within the plane.
|
|
Experimental: Inguinal Hernia Surgery (Group I)
Half of the study participants named Group T were administered Ultrasound Guided Transversus Abdominis Plane Nerve Block and the other half named Group I were administered Ilioinguinal & Iliohypogastric Nerve Block before the Inguinal Hernia Surgery.
|
The ultrasound probe was placed immediately medial and slightly cephalad to the upper aspect of the anterior superior iliac spine to obtain a short-axis view of the nerves situated between the two abdominal muscles (internal oblique and transversus abdominis), A 22 G needle tip ~1 cm caudal to the probe surface was introduced and was advanced until a characteristic 'tenting' of the interface between the two muscles was seen and was then further advanced deep to this interface until a pop was felt and then the injectate (0.2 mL/kg of 0.25 % bupivacaine) was observed spreading between these two layers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean duration of Postoperative Analgesia
Time Frame: 6 months
|
The study was conducted to compare the mean duration of postoperative analgesia in patients undergoing inguinal hernia repair surgery treated with transversus abdominis plane block versus the mean duration of postoperative analgesia in patients undergoing inguinal hernia repair surgery treated with ilioinguinal and iliohypogastric nerve block.
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6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 9, 2024
Primary Completion (Actual)
July 28, 2024
Study Completion (Actual)
July 28, 2024
Study Registration Dates
First Submitted
February 2, 2025
First Submitted That Met QC Criteria
February 2, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 25, 2025
Last Verified
September 1, 2024
More Information
Terms related to this study
Keywords
- nerve block
- transversus abdominis plane block
- bupivacaine
- postoperative analgesia
- nerve blocks
- TAP block
- ultrasound guided nerve block
- hernioplasty
- transversus abdominis
- ultrasound guided nerve blocks
- postop analgesia
- inguinal hernia surgery
- ilioinguinal/ iliohypogastric nerve block
- ilioinguinal/iliohypogastric nerve block
- abdominal nerve block
- 0.25% bupivacaine
- 0.25 percent bupivacaine
- internal oblique
- IIN
- IHN
- IIN/ IHN
- II/ IH nerve block
- transversus abdominis muscle
- ilioinguinal muscle
- iliohypogastric muscle
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Pathological Conditions, Anatomical
- Neurobehavioral Manifestations
- Hernia, Abdominal
- Perceptual Disorders
- Hernia
- Hernia, Inguinal
- Agnosia
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Anesthetics, Local
- Anesthetics
- Central Nervous System Depressants
- Sensory System Agents
- Bupivacaine
Other Study ID Numbers
- 530/ 2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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