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Clinical Trials/NCT06519708
NCT06519708
Completed
Not Applicable

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

National Cancer Institute, Egypt1 site in 1 country70 target enrollmentJuly 25, 2024

Overview

Phase
Not Applicable
Intervention
Erector Spinae Plane Block
Conditions
Analgesia
Sponsor
National Cancer Institute, Egypt
Enrollment
70
Locations
1
Primary Endpoint
Total amount of morphine consumption
Status
Completed
Last Updated
3 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
July 25, 2024
End Date
January 17, 2026
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National Cancer Institute, Egypt
Responsible Party
Principal Investigator
Principal Investigator

Osama Sayed Mohamed Ibrahim

Assistant Lecturer of Anesthesiology, Intensive Care Unit and Pain Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt.

National Cancer Institute, Egypt

Eligibility Criteria

Inclusion Criteria

  • Age (18-65) Years.
  • Both sexes.
  • Body mass index (BMI): (20-40) kg/m
  • 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

Arms & Interventions

Erector Spinae Plane Block

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

Intervention: Erector Spinae Plane Block

External Oblique Intercostal Plane Block

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.

Intervention: External Oblique Intercostal Plane Block

Outcomes

Primary Outcomes

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

  • Time of first rescue analgesia(24 hours postoperatively)
  • Mean arterial blood pressure(Till the end of surgery)
  • Complications(24 hours postoperatively)
  • Total amount of intraoperative fentanyl consumption(Intraoperatively)
  • Heart rate(Till the end of surgery)
  • Patient satisfaction(24 hours postoperatively)

Study Sites (1)

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