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NCT Number: NCT06519708

Analgesic Efficacy of Erector Spinae Plane Block vs External Oblique Intercostal Plane Block in Subcostal Cancer Surgeries

This study aims to evaluate the impact of ultrasound-guided erector spinae plane block compared to ultrasound-guided external oblique intercostal plane block regarding management of postoperative acute pain in patients undergoing above Umbilical surgical procedure.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Cairo Governorate, 11796, Egypt

About this study

Subcostal incisions in cancer surgeries as in hepatectomy and nephrectomy are a cause of severe pain and can lead to significant respiratory impairment. Regional anesthesia of the trunk and abdominal wall is usually centered on epidural analgesia.

Erector spinae plane block (ESPB) is the deposition of local anesthetic (LA) in the interfascial plane at the paraspinal region. It provides effective visceral and somatic analgesia.

The recently described external oblique intercostal plane block (EOIPB) is a simple, effective, and convenient block, particularly in the context of morbid obesity, at which local anesthetic (LA) is deposited in the interfacial plane deep to external oblique muscle at the sixth intercostal space. It provides a blockade of the thoracoabdominal nerves at the level of T6 to T10.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age (18-65) Years.
  • Both sexes.
  • Body mass index (BMI): (20-40) kg/m2.
  • American Society of Anesthesiology (ASA) physical status II, III.
  • Type of surgery; unilateral subcostal incision in hepatectomy and nephrectomy.

Exclusion criteria

  • Patient refusal.
  • Subcostal incisions that are crossing the midline or midline incision.
  • Age <18 years or >65 years
  • BMI <20 kg/m2 and >40 kg/m2
  • Known sensitivity or contraindication to drugs used in the study
  • Contraindication to regional anesthesia e.g. local infection at the site of introduction, pre-existing peripheral neuropathies, and coagulopathy.
  • Pregnancy.
  • Physical status ASA IV
  • patients on chronic analgesic therapy (daily morphine ≥30 mg or equivalent dose of other opioids or tramadol or any medication for neuropathic pain)
  • patients with a history of drug abuse
  • patients with neuropsychiatric diseases; patients with a history of chronic pain syndromes that may enhance sensitivity to pain, for example, fibromyalgia
  • All patients who are going to have severe intra- or post-operative bleeding or will require postoperative mechanical ventilation are also excluded from the study.

Treatment and study plan

Erector Spinae Plane Block

Drug

Patients will receive an ultrasound-guided erector spinae plane block with the injection of 30 ml bupivacaine 0.25% after induction of general anesthesia.

External Oblique Intercostal Plane Block

Drug

Patients will receive an ultrasound-guided external oblique intercostal plan block Intraoperative with the injection of 30 ml bupivacaine 0.25% after induction of general anesthesia.

Primary outcomes

  1. Total amount of morphine consumption

    Time frame: 24 hours postoperatively

    Rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the patient indicates Numeric Pain Rating Scale ≥ 4. The total amount of morphine given in 24 hours will be recorded for the two groups. A maximum dose of 0.5 mg/kg/24hours of morphine is allowed.

Secondary outcomes

  1. Total amount of intraoperative fentanyl consumption

    Time frame: Intraoperatively

    Rescue analgesia of fentanyl 1 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.

  2. Heart rate

    Time frame: Till the end of surgery

    Heart rate will be recorded intraoperatively at 5-minute intervals till the end of surgery and the average of each three successive readings.

  3. Mean arterial blood pressure

    Time frame: Till the end of surgery

    Mean arterial blood pressure will be recorded intraoperatively at 5-minute intervals till the end of surgery and the average of each three successive readings.

  4. Time of first rescue analgesia

    Time frame: 24 hours postoperatively

    Time of first rescue analgesia will be recorded from the end of surgery to first dose of morphine administrated. Rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the patient indicates Numeric Pain Rating Scale ≥ 4.

  5. Complications

    Time frame: 24 hours postoperatively

    Complications related to blocks (local anesthetic systemic toxicity, pneumothorax and arterial puncture) and Morphine related complications (respiratory depression, urine retention or pruritis) will be recorded.

  6. Patient satisfaction

    Time frame: 24 hours postoperatively

    Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Official study title

Analgesic Efficacy of Erector Spinae Plane Block vs External Oblique Intercostal Plane Block in Subcostal Cancer Surgeries: A Randomized Controlled Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 25, 2024
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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