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

Sponsor

Menoufia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06056479

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Procedure: external oblique intercostal block	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Efficacy Of Ultrasound Guided External Oblique Intercostal Plane Block for Postoperative Analgesia in Patients Undergoing Subcostal Nephrectomy: A Randomised Trial

Actual Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: external oblique intercostal block after induction 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.	Procedure: external oblique intercostal block 20 ml of bupivacaine 0.25% will be administered by US into external oblique intercostal plane at the level of sixth rib space .
No Intervention: postoperative morphine per patient request 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

Arm

Intervention/Treatment

Active Comparator: external oblique intercostal block after induction

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.

Procedure: external oblique intercostal block

20 ml of bupivacaine 0.25% will be administered by US into external oblique intercostal plane at the level of sixth rib space .

No Intervention: postoperative morphine per patient request

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

Outcome Measures

Primary Outcome Measures

Time for first rescue analgesia [day 0]
hours

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Menoufia university	Cairo	Shibin Elkom	Egypt

Sponsors and Collaborators

Menoufia University

Investigators

Principal Investigator: AMAL G SAFAN, MD, Menoufia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amal Gouda Elsayed Safan, lecturer of anaethesia, Menoufia University

ClinicalTrials.gov Identifier:

NCT06056479

Other Study ID Numbers:

9/2023ANET1-1

First Posted:

Sep 28, 2023

Last Update Posted:

Sep 28, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Sep 28, 2023