Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block
Primary Purpose
Inguinal Hernia Repair, Pain, Postoperative
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Levo-bupivacaine 0.25
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia Repair
Eligibility Criteria
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
Sites / Locations
- Mansoura university Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Quadratus Lumborum Block group
Ilioinguinal/Iliohypogastric Nerve Block group
Arm Description
Quadratus lumborum group (Q) (n=30): patients will receive Quadratus Lumborum Block using 20 mL of 0.25% Levo-bupivacaine
Ilioinguinal/Iliohypogastric Nerve Block group (I) (n=30): patients will receive Ilioinguinal/Iliohypogastric Nerve Block using 5 mL of 0.25%Levo- bupivacaine
Outcomes
Primary Outcome Measures
Post Operative Pain
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05559437
Brief Title
Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block
Official Title
Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block Compared to Posterior Quadratus Lumborum Block in Patients Undergoing Inguinal Hernia Repair
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
April 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egymedicalpedia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Abdominal wall hernias are common, with a prevalence of 1.7% for all ages and 4% for those aged over 45 years. Inguinal hernias account for 75% of abdominal wall hernias, with a lifetime risk of 27% in men and 3% in women. Repair of inguinal hernia is one of the most common operations in general surgery
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia Repair, Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
To investigate the effectiveness of ultrasound guided Ilioinguinal/Iliohypogastric ( II/IH) block compared to ultrasound guided Posterior Quadratus Lumborum (PQL) block in patients subjected to inguinal hernia repair.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quadratus Lumborum Block group
Arm Type
Experimental
Arm Description
Quadratus lumborum group (Q) (n=30): patients will receive Quadratus Lumborum Block using 20 mL of 0.25% Levo-bupivacaine
Arm Title
Ilioinguinal/Iliohypogastric Nerve Block group
Arm Type
Experimental
Arm Description
Ilioinguinal/Iliohypogastric Nerve Block group (I) (n=30): patients will receive Ilioinguinal/Iliohypogastric Nerve Block using 5 mL of 0.25%Levo- bupivacaine
Intervention Type
Drug
Intervention Name(s)
Levo-bupivacaine 0.25
Intervention Description
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
Primary Outcome Measure Information:
Title
Post Operative Pain
Description
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.
Time Frame
0 hour after the operation up to 24-hour analgesic after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mona Gad, Assist.Prof
Organizational Affiliation
Department of anesthesia and SICU,Faculty of medicine,Mansoura university , Egypt.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university Hospital
City
Mansoura
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block
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