Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block

NCT05559437 | Completed Phase 1 DMC

• 1 other identifier: Mona Gad
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Inguinal Hernia Repair; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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.

  0 hour after the operation up to 24-hour analgesic after surgery

Study Arms (2)

Quadratus Lumborum Block group

EXPERIMENTAL

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

Ilioinguinal/Iliohypogastric Nerve Block group

EXPERIMENTAL

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

Interventions

Levo-bupivacaine 0.25 DRUG

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

Ilioinguinal/Iliohypogastric Nerve Block group; Quadratus Lumborum Block group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• all patients undergoing elective or emergent unilateral inguinal hernia repair
• Patients scheduled for unilateral inguinal hernia repair

You may not qualify if:

• 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

Sponsors & Collaborators

• Egymedicalpedia: lead

Study Sites (1)

Mansoura university Hospital

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Mona Gad, Assist.Prof

  Department of anesthesia and SICU,Faculty of medicine,Mansoura university , Egypt.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 24, 2022
• First Posted: September 29, 2022
• Study Start: October 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 20, 2023
• Last Updated: October 19, 2023

Record last verified: 2023-10

Locations

EG (1)