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

NCT ID: NCT06519708

Condition: Analgesia
Erector Spinae Plane Block
External Oblique Intercostal Plane Block
Subcostal Cancer Surgeries

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Single (Participant)

Intervention:

Intervention type: Drug
Intervention name: Erector Spinae Plane Block
Description: Patients will receive an ultrasound-guided erector spinae plane block with the injection of 30 ml bupivacaine 0.25% after induction of general anesthesia.
Arm group label: Erector Spinae Plane Block

Intervention type: Drug
Intervention name: External Oblique Intercostal Plane Block
Description: 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.
Arm group label: External Oblique Intercostal Plane Block

Summary: 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.

Detailed description: 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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Locations:

Facility:
Name: Cairo University

Address:
City: Cairo
Zip: 11796
Country: Egypt

Status: Recruiting

Contact:
Last name: Osama S Ibrahim, Master

Phone: 00201141383007
Email: dr.osm391@yahoo.com

Investigator:
Last name: Ekrami M Abdelghafar, MD
Email: Sub-Investigator

Investigator:
Last name: Ahmed H Bakeer, MD
Email: Sub-Investigator

Investigator:
Last name: Fatma H Mustafa, MD
Email: Sub-Investigator

Investigator:
Last name: Norma O Zayed, MD
Email: Sub-Investigator

Start date: July 25, 2024

Completion date: May 27, 2025

Lead sponsor:
Agency: National Cancer Institute, Egypt
Agency class: Other

Source: National Cancer Institute, Egypt

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06519708

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