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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06056479
Recruitment Status : Completed
First Posted : September 28, 2023
Last Update Posted : March 7, 2024
Sponsor:
Information provided by (Responsible Party):
Amal Gouda Elsayed Safan, Menoufia University

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual 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 : September 1, 2023
Actual Primary Completion Date : February 10, 2024
Actual Study Completion Date : February 25, 2024
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Time for first rescue analgesia [ Time Frame: day 0 ]
    hours


Secondary Outcome Measures :
  1. VAS score [ Time Frame: 24 hours ]
    1 to 10 (0 is interpreted as no pain, 1-4 mild pain, 5-6 moderate pain, 7-10 severe pain)

  2. rescue analgesics [ Time Frame: 24hous ]
    morphine mg


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06056479


Locations
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Egypt
Menoufia university
Cairo, Shibin Elkom, Egypt
Sponsors and Collaborators
Menoufia University
Investigators
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Principal Investigator: AMAL G SAFAN, MD Menoufia University
More Information
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Responsible Party: Amal Gouda Elsayed Safan, lecturer of anaethesia, Menoufia University
ClinicalTrials.gov Identifier: NCT06056479    
Other Study ID Numbers: 9/2023ANET1-1
First Posted: September 28, 2023    Key Record Dates
Last Update Posted: March 7, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations