QIPB in Inguinal Hernia

NCT ID: NCT06862609

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-23
• Study Completion Date: 2025-11-30

Brief Summary

Inguinal hernia repair is one of the most commonly performed surgical procedures. It is generally performed under regional anesthesia techniques, such as local anesthesia, peripheral nerve blocks, or neuraxial anesthesia (spinal or epidural anesthesia), or under general anesthesia. Despite various available analgesic regimens, numerous studies have demonstrated that postoperative pain control remains inadequate. Opioids, nonsteroidal anti-inflammatory drugs, and analgesics are frequently used for postoperative pain management. However, these medications are associated with uncertain efficacy and undesirable side effects. Pain is a critical factor in the postoperative period, contributing to delayed ambulation and paralytic ileus, ultimately hindering early discharge.

Detailed Description

Inguinal hernia repair is one of the most commonly performed surgical procedures. It is generally performed under regional anesthesia techniques, such as local anesthesia, peripheral nerve blocks, or neuraxial anesthesia (spinal or epidural anesthesia), or under general anesthesia. Despite various available analgesic regimens, numerous studies have demonstrated that postoperative pain control remains inadequate. Opioids, nonsteroidal anti-inflammatory drugs, and analgesics are frequently used for postoperative pain management. However, these medications are associated with uncertain efficacy and undesirable side effects. Pain is a critical factor in the postoperative period, contributing to delayed ambulation and paralytic ileus, ultimately hindering early discharge. Recently, Tulgar and colleagues introduced a novel fascial plane block known as the "quadro-iliac plane block". Quadro-iliac plane block is performed within the quadro-iliac plane, located between the inner surface of the iliac crest and the posterior surface of the quadratus lumborum muscle. In their study, Tulgar et al. bilaterally injected 40 mL of methylene blue into the quadro-iliac plane. They observed widespread dye dispersion along the anterior and posterior surfaces of the quadratus lumborum muscle, transversalis fascia, ilioinguinal, iliohypogastric, subcostal, and genitofemoral nerves, as well as the lumbar plexus. Based on these findings, quadro-iliac plane block has been proposed as a potentially effective technique for managing acute or chronic pain in the lumbosacral, abdominal, and hip regions.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

control group

All patients will receive IV paracetamol (1 g, 3×1) and IV tenoxicam (20 mg, 2×1). Rescue analgesia (IV tramadol 1 mg/kg) will be administered if Numerical rating scale scores are ≥3. IV ondansetron (4 mg) will be given for nausea and vomiting.

Group Type: OTHER

Quadro iliac plane block

Intervention Type: OTHER

Patients in Group Q will be placed in the lateral position. A low-frequency convex transducer and a 100-mm block needle will be used. Following sterilization, the transducer will be placed parasagittally at the distal attachment of the quadratus lumborum muscle to the iliac crest. The iliac crest and quadratus lumborum muscle will be visualized, with the erector spinae muscle above and the psoas major muscle below. Using an in-plane technique, the needle will be directed toward the iliac crest. After confirmation with 5 mL of isotonic sodium chloride, 40 mL of 0.25% bupivacaine will be injected incrementally with intermittent aspiration.

Quadro iliac plane block

All patients will receive IV paracetamol (1 g, 3×1) and IV tenoxicam (20 mg, 2×1). Rescue analgesia (IV tramadol 1 mg/kg) will be administered if Numerical rating scale scores are ≥3. IV ondansetron (4 mg) will be given for nausea and vomiting. Group Q patients will receive quadro iliac plane block in addition to standard analgesia.

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: OTHER

All patients will receive IV paracetamol (1 g, 3×1) and IV tenoxicam (20 mg, 2×1).

Interventions

Quadro iliac plane block

Patients in Group Q will be placed in the lateral position. A low-frequency convex transducer and a 100-mm block needle will be used. Following sterilization, the transducer will be placed parasagittally at the distal attachment of the quadratus lumborum muscle to the iliac crest. The iliac crest and quadratus lumborum muscle will be visualized, with the erector spinae muscle above and the psoas major muscle below. Using an in-plane technique, the needle will be directed toward the iliac crest. After confirmation with 5 mL of isotonic sodium chloride, 40 mL of 0.25% bupivacaine will be injected incrementally with intermittent aspiration.

Intervention Type: OTHER

Control group

All patients will receive IV paracetamol (1 g, 3×1) and IV tenoxicam (20 mg, 2×1).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients aged 18-65 years
• Undergoing elective,
• unilateral laparoscopic inguinal hernia repair
• Receiving general anesthesia

Exclusion Criteria

• Patients who refuse to provide consent
• Patients with contraindications to regional anesthesia
• Patients with impaired consciousness
• Patients with coagulopathy
• Patients with infections at the block site
• Emergency cases

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Konya City Hospital

OTHER

Sponsor Role: lead

Responsible Party

Muhammed Halit Satici

Specialist, M.D., Department of members Anesthesiology and Reanimation, Konya City Hospital, M.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Konya City Hospital

Konya, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Facility Contacts

Muhammed H SATICI, M.D

Role: primary

halit_satici@hotmail.com

5455636333 ext. +90

Other Identifiers

QIPB İnguinal hernia

Identifier Type: -

Identifier Source: org_study_id