search
Back to results

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

Primary Purpose

Post Operative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
external oblique intercostal block
Erector Spine block
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post Operative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Menoufia universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

external oblique intercostal block

Erector Spine Block

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

time for first rescue analgesia
hours

Secondary Outcome Measures

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)
the number of rescue analgesics
numbers'

Full Information

First Posted
September 11, 2023
Last Updated
September 20, 2023
Sponsor
Menoufia University
search

1. Study Identification

Unique Protocol Identification Number
NCT06048744
Brief Title
Ultrasound Guided Erector Spinae Plane Block vs External Oblique Intercostal Plane Block for Nephrectomy
Acronym
EOINBvsESB
Official Title
Ultrasound Guided Erector Spinae Plane Block vs External Oblique Intercostal Plane Block for Postoperative Analgesia in Patients Undergoing Subcoastal Nephrectomy: A Randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
external oblique intercostal block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Erector Spine Block
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
external oblique intercostal block
Intervention Description
U S guided external oblique intercostal block after induction.
Intervention Type
Procedure
Intervention Name(s)
Erector Spine block
Intervention Description
US guided erector spine block after induction
Primary Outcome Measure Information:
Title
time for first rescue analgesia
Description
hours
Time Frame
day 0
Secondary Outcome Measure Information:
Title
visual analogue score VAS score
Description
(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)
Time Frame
24 hours
Title
the number of rescue analgesics
Description
numbers'
Time Frame
24hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AMAL G SAFAN, MD
Phone
01027386221
Email
AMAL.GODA52@med.menofia.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AMAL G SAFAN, MD
Organizational Affiliation
Menoufia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Menoufia university
City
Cairo
State/Province
Shibin Elkom
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AMAL G SAFAN, MD
Phone
0102738621
Email
AMAL.GODA52@med.menofia.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs