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Efficacy Of Ultrasound Guided External Oblique Intercostal Plane Block for Subcostal Nephrectomy (EOINB)

Primary Purpose

Postoperative Pain

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

About this trial

This is an interventional other trial for Postoperative Pain

Eligibility Criteria

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

Inclusion Criteria: - Eligible patients will be older than 18 years old with American society of anestheologist ASA physical status I, II and III scheduled for Trans-Abdominal ( Anterior Subcostal) Nephrectomy Exclusion Criteria: Patients who are: Unable to cooperate. Patients who have allergy to any of the study drugs. Patients who are on opioids. Known abuse of alcohol or medication. Local infection at the site of injection or systemic infection. Pregnancy Patients with coagulation disorders or on anticoagulation therapy

Sites / Locations

  • Menoufia universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

external oblique intercostal block after induction

postoperative morphine per patient request

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. Initially the probe is placed in a cephalad to caudad paramedian direction at the anterior axillary line, and the external oblique muscle identified at the level ribs 6 and 7 in line with the xiphoid process. To confirm correct identification of the external oblique muscle, With 17gauge echogenic ultrasound needle will be advanced in plane from a superomedial-to-inferolateral direction, through the external oblique muscle.30 ml of bupivacaine 0.25% will be administered incrementally.

In this group no block will be done only morphine will be given intraoperatively- according to hemodynamic change and postoperative by morphine per patient request

Outcomes

Primary Outcome Measures

Time for first rescue analgesia
hours

Secondary Outcome Measures

visual analogue scale VAS score
1 to 10
rescue analgesics
24 hours

Full Information

First Posted
September 11, 2023
Last Updated
September 20, 2023
Sponsor
Menoufia University
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1. Study Identification

Unique Protocol Identification Number
NCT06056479
Brief Title
Efficacy Of Ultrasound Guided External Oblique Intercostal Plane Block for Subcostal Nephrectomy
Acronym
EOINB
Official Title
Efficacy Of Ultrasound Guided External Oblique Intercostal Plane Block for Postoperative Analgesia in Patients Undergoing Subcostal 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
February 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 external oblique intercostal block after induction. Group B: will receive postoperative morphine per patient request.
Detailed Description
General anaesthesia induction will be achieved using fentanyl 1µg/kg (IV), propofol 2mg/kg (IV), and0.5mg/kg of IV Atracurium. General anaesthesia will be maintained with mechanical ventilation with isoflurane with O2 \ Air mixture. During anaesthesia maintenance Intraoperatively, if BP or heart rate (HR) increase more than 20% from baseline, intravenous morphine will be given to stabilize the patients' haemodynamics. All patients will receive 1g intravenous paracetamol and 4mg ondansetron 8mg dexamethasone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative 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 after induction
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. Initially the probe is placed in a cephalad to caudad paramedian direction at the anterior axillary line, and the external oblique muscle identified at the level ribs 6 and 7 in line with the xiphoid process. To confirm correct identification of the external oblique muscle, With 17gauge echogenic ultrasound needle will be advanced in plane from a superomedial-to-inferolateral direction, through the external oblique muscle.30 ml of bupivacaine 0.25% will be administered incrementally.
Arm Title
postoperative morphine per patient request
Arm Type
No Intervention
Arm Description
In this group no block will be done only morphine will be given intraoperatively- according to hemodynamic change and postoperative by morphine per patient request
Intervention Type
Procedure
Intervention Name(s)
external oblique intercostal block
Intervention Description
20 ml of bupivacaine 0.25% will be administered by US into external oblique intercostal plane at the level of sixth rib space .
Primary Outcome Measure Information:
Title
Time for first rescue analgesia
Description
hours
Time Frame
day 0
Secondary Outcome Measure Information:
Title
visual analogue scale VAS score
Description
1 to 10
Time Frame
24 hours
Title
rescue analgesics
Description
24 hours
Time Frame
24hous

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 18 years old with American society of anestheologist ASA physical status I, II and III scheduled for Trans-Abdominal ( Anterior Subcostal) Nephrectomy Exclusion Criteria: Patients who are: Unable to cooperate. Patients who have allergy to any of the study drugs. Patients who are on opioids. Known abuse of alcohol or medication. Local infection at the site of injection or systemic infection. Pregnancy Patients 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

Efficacy Of Ultrasound Guided External Oblique Intercostal Plane Block for Subcostal Nephrectomy

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