NCT07094386

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

August 15, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

August 17, 2025

Status Verified

July 1, 2025

Enrollment Period

8 months

First QC Date

July 16, 2025

Last Update Submit

August 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to first requested rescue analgesia (minutes)

    24 hours postoperatively

Study Arms (2)

Group External Oblique Intercostal Plain Block (EOIPB)

ACTIVE COMPARATOR

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

Procedure: External Oblique Intercostal Plain BlockDrug: Bupivacaine %0.25 (isobaric)

Group Quadratus Lumborum Block (QLB)

ACTIVE COMPARATOR

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

Procedure: Quadratus Lumborum BlockDrug: Bupivacaine %0.25 (isobaric)

Interventions

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

Group External Oblique Intercostal Plain Block (EOIPB)

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.

Group Quadratus Lumborum Block (QLB)

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 External Oblique Intercostal Plain Block (EOIPB)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients from both sexes.
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Nesrine Elrefai, Professor

    Cairo university, Faulty of Mdicine

    STUDY DIRECTOR
  • Ahmed El Sakka, Professor

    Cairo university, Faulty of Mdicine

    STUDY CHAIR

Central Study Contacts

Nesrine Elrefai, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 16, 2025

First Posted

July 30, 2025

Study Start

August 15, 2025

Primary Completion

April 15, 2026

Study Completion

April 15, 2026

Last Updated

August 17, 2025

Record last verified: 2025-07

Locations