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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06056479
Other study ID # 9/2023ANET1-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date February 25, 2024

Study information

Verified date March 2024
Source Menoufia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date February 25, 2024
Est. primary completion date February 10, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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 .

Locations

Country Name City State
Egypt Menoufia university Cairo Shibin Elkom

Sponsors (1)

Lead Sponsor Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time for first rescue analgesia hours day 0
Secondary VAS score 1 to 10 (0 is interpreted as no pain, 1-4 mild pain, 5-6 moderate pain, 7-10 severe pain) 24 hours
Secondary rescue analgesics morphine mg 24hous
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