- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05559437
Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block
Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block Compared to Posterior Quadratus Lumborum Block in Patients Undergoing Inguinal Hernia Repair
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The peripheral nerve block usage is increasing in popularity because it decreases pain as estimated by visual analogue scores/numerical rating pain scores postoperatively and decreases the need for postoperative analgesic usage thereby reducing opioid induced side effects like postoperative respiratory depression, nausea, vomiting, NSAID induced gastritis etc. Nerve blocks also shorten Post-Anesthesia Care Unit stay time, and also increases patient satisfaction .
Ultrasound-guided peripheral nerve blocks including ilioinguinal/ iliohypogastric nerve block and transversus abdominis plane block have been widely used and considered as effective traditional techniques for postoperative analgesia in inguinal hernia repair .
In recent years, the quadratus lumborum (QL) block is proposed to be an alternative regional block for both upper abdominal surgery and lower abdominal surgery.
The blockade of ilioinguinal/iliohypogastric nerves in the anterior abdominal wall has improved postoperative analgesia after open inguinal hernia repair and many other procedures.
The Quadratus Lumborum (QL) Block is a regional anesthetic technique which described by anesthesiologist "DR Rafael Blanco" in 2007. Quadratus Lumborum block allows the local anesthetic agent to spread between the posterior aspect of the Quadratus Lumborum muscle and the middle layer of the Thoracolumbar fascia, which is nearer to the thoracic paravertebral space. It has four approaches based on the point of drug deposition in relation to quadratus lumborum muscle. Drug is deposited on the anterolateral, posterior, anterior to the Quadratus Lumborum muscle in the three approaches. In fourth approach drug is deposited intramuscularly. It provides postoperative analgesia for longer duration .
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
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Mansoura, Egypt
- Mansoura University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- all patients undergoing elective or emergent unilateral inguinal hernia repair
- Patients scheduled for unilateral inguinal hernia repair
Exclusion Criteria:
- Patient refusal.
- Contraindication to neuraxial block.
- neuromuscular diseases (as myopathies, myasthenia gravies).
- Hematological diseases, bleeding or coagulation abnormality.
- Uncontrolled Psychiatric diseases,
- Local skin infection and sepsis at site of the block.
- Known intolerance to the study drugs.
- Body Mass Index > 40 Kg/m2,
- Unstable cardiovascular condition
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Quadratus Lumborum Block group
Quadratus lumborum group (Q) (n=30): patients will receive Quadratus Lumborum Block using 20 mL of 0.25% Levo-bupivacaine
|
The blockade of ilioinguinal/iliohypogastric nerves in the anterior abdominal wall has improved postoperative analgesia after open inguinal hernia repair.
Other new blocks needs to be investigated
|
|
Experimental: Ilioinguinal/Iliohypogastric Nerve Block group
Ilioinguinal/Iliohypogastric Nerve Block group (I) (n=30): patients will receive Ilioinguinal/Iliohypogastric Nerve Block using 5 mL of 0.25%Levo- bupivacaine
|
The blockade of ilioinguinal/iliohypogastric nerves in the anterior abdominal wall has improved postoperative analgesia after open inguinal hernia repair.
Other new blocks needs to be investigated
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post Operative Pain
Time Frame: 0 hour after the operation up to 24-hour analgesic after surgery
|
All patients will be familiar with the use of the visual analogue scale score identifying 0 as no pain and 10 as worst imaginable pain.
|
0 hour after the operation up to 24-hour analgesic after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mona Gad, Assist.Prof, Department of anesthesia and SICU,Faculty of medicine,Mansoura university , Egypt.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pathological Conditions, Anatomical
- Hernia, Abdominal
- Pain, Postoperative
- Hernia
- Hernia, Inguinal
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
- Bupivacaine
- Levobupivacaine
Other Study ID Numbers
- Mona Gad
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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