Ultrasound Guided Erector Spinae Plane Block vs External Oblique Intercostal Plane Block for Nephrectomy (EOINBvsESB)

Ultrasound Guided Erector Spinae Plane Block vs External Oblique Intercostal Plane Block for Postoperative Analgesia in Patients Undergoing Subcoastal Nephrectomy: A Randomised Trial

The patients will be randomly allocated into two equal groups using a computer program.

Group A: will receive U S guided external oblique intercostal block after induction.

Group B:

Patients will receive US guided erector spine block after induction.

Study Overview

• Status: Completed
• Conditions: Post Operative Pain
• Intervention / Treatment: Procedure: external oblique intercostal block; Procedure: Erector Spine block

Detailed Description

Patients will be premedicated with IV midazolam (0.05 mg/kg). Under standard monitoring including Electrocardiography, Non-Invasive Blood Pressure, and Pulse Oximetry. General Anesthesia will be induced with Fentanyl (1-2 μg/kg), Propofol (2-3 mg/kg), and Atracurium (0.5-0.8 mg/kg). Pressure controlled Volume guarantee Ventilation mode will be used to maintain O2 Saturation Above 98%. Anesthesia will be maintained with Isoflurane 1.2 Minimum Alveolar Concentration inhalation

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Shibin Elkom
    • Cairo, Shibin Elkom, Egypt
      • Menoufia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Eligible patients will be older than 21 years old with American society of anesthesiology ASA physical status I& II&III scheduled for elective (Subcostal) Nephrectomy

Exclusion Criteria:

• Patients who are:
• Uncooperative.
• Having allergy to any of the study drugs.
• Known abuse of alcohol or medication.
• Having Local infection at the site of injection or systemic infection.
• Pregnancy.
• With coagulation disorders or on anticoagulation therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: external oblique intercostal block; After induction of general anesthesia, external oblique intercostal blocks will be performed with patients positioned in the supine position with their ipsilateral arm abducted. A 14-15 MHz linear ultrasound transducer (Sono-Site) was placed in the sagittal plane between the midclavicular and anterior axillary lines at the level of sixth rib. 30 ml of bupivacaine 0.25% will be administered incrementally. The drug will be injected after a negative aspiration into the plane deep to the external oblique muscle and superficial to the sixth and seventh ribs and their associated intercostal muscles.	Procedure: external oblique intercostal block; U S guided external oblique intercostal block after induction.
Active Comparator: Erector Spine Block; After induction of general anesthesia, patients will be positioned in the lateral position . A linear ultrasound transducer will be placed on the midline to identify the T8 spinous process. From this position, the ultrasound transducer was moved 2-3 cm laterally to visualize the hyperechoic line of the T8 transverse process with its associated acoustic shadow inferiorly, and the overlying erector spinae muscle superiorly. 30 ml 0.25% bupivacaine will be injected.	Procedure: Erector Spine block; US guided erector spine block after induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time for first rescue analgesia	hours	day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analogue score VAS score	(a scale from 0 to 10 where 0 is interpreted as no pain, 1-4 mild pain, 5-6 moderate pain, 7-10 severe pain) will be recorded 15 min after extubation (as soon as the patient will be alert enough to report pain)	24 hours
the number of rescue analgesics	numbers'	24hours

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Principal Investigator: AMAL G SAFAN, MD, Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): January 25, 2024

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 9/2023ANET1-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No