Postoperative Analgesia in Patients Undergoing Open Upper Abdominal Surgeries: External Oblique Intercostal Plane Block vs. Quadratus Lumborum Block

NCT ID: NCT07094386

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2026-04-15

Brief Summary

Open upper abdominal surgeries with subcostal incisions are a cause of severe pain and can lead to pulmonary and cardiac complications, detrimental physiological effects, and may also have psychological, economic, and social adverse effects if inadequately treated. Effective pain control can avoid these complications and contribute to several clinically valuable outcomes, including earlier patient mobilization and quicker recovery, which can result in a shortened hospital stay and reduced costs.

Opioids are the gold standard in postoperative pain control. however, it increases the incidence of opioid related adverse events such as respiratory depression, dizziness, nausea, vomiting and constipation. Regional analgesia plays an important role in perioperative multimodal analgesic regimens for major abdominal surgeries. The ultrasound-guided technique provides several options for relieving postoperative pain.

The aim of this study is to compare the efficacy and safety of ultrasound guided external oblique intercostal plane block versus quadratus lumborum in patients undergoing open upper abdominal surgeries.

Detailed Description

Poorly controlled postoperative pain causes physiological stress, increased morbidity, delayed mobilization, prolonged hospitalization, and higher healthcare costs.

Regional anelgesia techniques have shown a promise in improving postoperative outcomes by reducing opioid consumption and related adverse effects.

This study aims to evaluate two regional blocks - EOIPB and QLB- both will be performed under ultrasound guidance.

The goal is to determine which technique offers superior analgesic efficacy, safety and overall contribution to the quality of recovery.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group External Oblique Intercostal Plain Block (EOIPB)

Patients will receive general anesthesia initially then unilateral EOIPB with total volume 30 ml of bupivacaine 0.25% will be performed.

Group Type: ACTIVE_COMPARATOR

External Oblique Intercostal Plain Block

Intervention Type: PROCEDURE

The patient will be placed in the supine position. After sterilization of the skin, a high-frequency linear probe (6-13 MHz) will be placed obliquely medial to the anterior axillary line, the 6th and 7th ribs, skin, subcutaneous tissues, and external oblique muscle \[EOM\], intercostal muscles, pleura, and the lung will be identified. An 80 mm 22-gauge block needle (Stimuplex® D, BBraun, Germany) will be inserted in-plane to the US-probe in a craniocaudal direction directed under EOM. After confirmation of negative blood aspiration, 2-3 mL of normal saline will be injected for hydro-dissection to verify the correct needle tip placement then 30 mL of 0.25% bupivacaine will be injected between the EOM and intercostal muscles

Bupivacaine %0.25 (isobaric)

Intervention Type: DRUG

A single injection of 30 mg of 0.25 % bupivacaine will be administered as part of the External Oblique Intercostal Plain Block under ultrasound guidance, after confirming needle placement between the external oblique and intercostal muscles.

Group Quadratus Lumborum Block (QLB)

Patients will receive general anesthesia initially then unilateral QLB with total volume 30 ml of bupivacaine 0.25% will be performed.

Group Type: ACTIVE_COMPARATOR

Quadratus Lumborum Block

Intervention Type: PROCEDURE

Quadratus lumborum block will be performed. The patient will be placed in the lateral decubitus position After sterilization of the skin, a low frequency convex probe (5-8 MHz) will be positioned horizontally in the anterior axillary line half way between the subcostal margin and the iliac crest then will be advanced in the cranial direction to visualize the triple abdominal muscle layers and identifying the posterior border of the EO muscle (hook sign) with the underlying IO musclenforming a roof over the QL muscle. The QL muscle could be visualized with its attachment to the lateral edge of the transverse process of the L4 vertebral body. An 80 mm 22-gauge block needle will be inserted in-plane to the US-probe in an anterolateral to posteromedial direction. The needle tip will be placed between the middle layer of the thoracolumbar fascia and the QL muscle. After confirmation of negative blood aspiration, 30 mL of 0.25% bupivacaine will be injected.

Bupivacaine %0.25 (isobaric)

Intervention Type: DRUG

A single injection of 30 mg of 0.25 % bupivacaine will be administered as part of the Quadratus Lumborum Block under ultrasound guidance, after confirming of correct needle placement and negative aspiration.

Interventions

External Oblique Intercostal Plain Block

The patient will be placed in the supine position. After sterilization of the skin, a high-frequency linear probe (6-13 MHz) will be placed obliquely medial to the anterior axillary line, the 6th and 7th ribs, skin, subcutaneous tissues, and external oblique muscle \[EOM\], intercostal muscles, pleura, and the lung will be identified. An 80 mm 22-gauge block needle (Stimuplex® D, BBraun, Germany) will be inserted in-plane to the US-probe in a craniocaudal direction directed under EOM. After confirmation of negative blood aspiration, 2-3 mL of normal saline will be injected for hydro-dissection to verify the correct needle tip placement then 30 mL of 0.25% bupivacaine will be injected between the EOM and intercostal muscles

Intervention Type: PROCEDURE

Quadratus Lumborum Block

Quadratus lumborum block will be performed. The patient will be placed in the lateral decubitus position After sterilization of the skin, a low frequency convex probe (5-8 MHz) will be positioned horizontally in the anterior axillary line half way between the subcostal margin and the iliac crest then will be advanced in the cranial direction to visualize the triple abdominal muscle layers and identifying the posterior border of the EO muscle (hook sign) with the underlying IO musclenforming a roof over the QL muscle. The QL muscle could be visualized with its attachment to the lateral edge of the transverse process of the L4 vertebral body. An 80 mm 22-gauge block needle will be inserted in-plane to the US-probe in an anterolateral to posteromedial direction. The needle tip will be placed between the middle layer of the thoracolumbar fascia and the QL muscle. After confirmation of negative blood aspiration, 30 mL of 0.25% bupivacaine will be injected.

Intervention Type: PROCEDURE

Bupivacaine %0.25 (isobaric)

A single injection of 30 mg of 0.25 % bupivacaine will be administered as part of the External Oblique Intercostal Plain Block under ultrasound guidance, after confirming needle placement between the external oblique and intercostal muscles.

Intervention Type: DRUG

Bupivacaine %0.25 (isobaric)

A single injection of 30 mg of 0.25 % bupivacaine will be administered as part of the Quadratus Lumborum Block under ultrasound guidance, after confirming of correct needle placement and negative aspiration.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients from both sexes.
• 18 to 60 years old.
• ASA physical status I- III scheduled for elective open upper abdominal surgeries, as (open nephrectomy, open cholecystectomy, liver resection, ….).
• Patients with BMI (18.5-35) kg/ m2.

Exclusion Criteria

• Patients uncooperative or refuse to sign the consent of regional block.
• Patients with known coagulation defects. International normalized ratio (INR)> 1.5), and thrombocytopenia if platelet count < 100.000).
• Patients with known hypersensitivity to bupivacaine, or any of the used drugs.
• Patients with hepatic impairment, as Child-Pugh class B or C, AST/ALT > 3 times the upper limit of normal, or total bilirubin > 2 mg/dL.
• Patients with renal impairment, chronic kidney disease stage 4 or 5 (eGFR < 30 mL/min/1.73 m²), or on regular dialysis.
• Patients with pre-existing myopathy, defined as a clinically diagnosed muscular disorder characterized by muscle weakness, elevated creatine kinase levels, or a history of inherited or acquired muscle disease (e.g., polymyositis, muscular dystrophy).
• Patients with pre-existing neuropathy, if clinically diagnosed as peripheral or central nerve dysfunction, including chronic sensorimotor deficits or conditions such as diabetic neuropathy, radiculopathy, or multiple sclerosis.
• Patients with chronic pain syndromes, defined as pain persisting for more than 3 months, including fibromyalgia, complex regional pain syndrome (CRPS), or chronic pain requiring long-term opioid or neuropathic pain medications.
• Patients with sepsis at the site of injection.
• Patients with history of long-acting opioids or steroids preoperatively

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Shaaban Glall Ismail

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nesrine Elrefai, Professor

Role: STUDY_DIRECTOR

Cairo university, Faulty of Mdicine

Ahmed El Sakka, Professor

Role: STUDY_CHAIR

Cairo university, Faulty of Mdicine

Locations

Cairo university hospitals

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Nesrine Elrefai, Professor

Role: CONTACT

nesrinerefai@hotmail.com

02- 01069573357

Facility Contacts

Cairo university hospitals

Role: primary

website@kasralainy.edu.eg

+20223647545

Other Identifiers

MD-135-2025

Identifier Type: -

Identifier Source: org_study_id