Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block

Sponsor
Egymedicalpedia (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05559437
Collaborator
(none)
60
1
2
6.6
9.1

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Levo-bupivacaine 0.25
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block Compared to Posterior Quadratus Lumborum Block in Patients Undergoing Inguinal Hernia Repair
Actual Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 20, 2023

Arms and Interventions

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

Drug: Levo-bupivacaine 0.25
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

Drug: Levo-bupivacaine 0.25
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

Outcome Measures

Primary Outcome Measures

  1. Post Operative Pain [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. all patients undergoing elective or emergent unilateral inguinal hernia repair

  2. Patients scheduled for unilateral inguinal hernia repair

Exclusion Criteria:
  1. Patient refusal.

  2. Contraindication to neuraxial block.

  3. neuromuscular diseases (as myopathies, myasthenia gravies).

  4. Hematological diseases, bleeding or coagulation abnormality.

  5. Uncontrolled Psychiatric diseases,

  6. Local skin infection and sepsis at site of the block.

  7. Known intolerance to the study drugs.

  8. Body Mass Index > 40 Kg/m2,

  9. Unstable cardiovascular condition

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mansoura university Hospital Mansoura Egypt

Sponsors and Collaborators

  • Egymedicalpedia

Investigators

  • Principal Investigator: Mona Gad, Assist.Prof, Department of anesthesia and SICU,Faculty of medicine,Mansoura university , Egypt.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Egymedicalpedia
ClinicalTrials.gov Identifier:
NCT05559437
Other Study ID Numbers:
  • Mona Gad
First Posted:
Sep 29, 2022
Last Update Posted:
Oct 20, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 20, 2022