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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