- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06056479
Efficacy Of Ultrasound Guided External Oblique Intercostal Plane Block for Subcostal Nephrectomy (EOINB)
Efficacy Of Ultrasound Guided External Oblique Intercostal Plane Block for Postoperative Analgesia in Patients Undergoing Subcostal Nephrectomy: A Randomised Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Shibin Elkom
-
Cairo, Shibin Elkom, Egypt
- Menoufia University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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. |
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time for first rescue analgesia
Time Frame: day 0
|
hours
|
day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
24 hours
|
|
rescue analgesics
Time Frame: 24hous
|
morphine mg
|
24hous
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: AMAL G SAFAN, MD, Menoufia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9/2023ANET1-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Pain
-
National and Kapodistrian University of AthensCompletedPostoperative Pain, Acute | Postoperative Pain, Chronic | Postoperative Pain After Thoracic SurgeryGreece
-
Second Affiliated Hospital, School of Medicine,...Not yet recruitingPostoperative Pain | Postoperative Pain Management | Postoperative Pain in Orthopaedics
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
University of MalayaActive, not recruitingPostoperative Pain | Postoperative Pain ManagementMalaysia
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
-
University Hospital, AntwerpUnknown
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Bezmialem Vakif UniversityRecruitingPostoperative Pain ManagementTurkey
-
Pacira Pharmaceuticals, IncCompletedPostoperative Pain ManagementUnited States
Clinical Trials on external oblique intercostal block
-
Seoul National University HospitalNot yet recruiting
-
Cairo UniversityRecruitingOpen Nephrectomy | External Oblique Intercostal Block | Rhomboid Intercostal Sub-serratus Plane BlockEgypt
-
Istanbul Medeniyet UniversityNot yet recruitingExternal Oblique Intercostal Plane Block | Subcostal Transverse Abdominis Plane Block
-
Antalya City HospitalNot yet recruitingPostoperative Pain | Regional Anaesthesia | Sleeve Gastrectomy | Intertransverse Process Block | External Oblique Intercostal Plane Block
-
Tanta UniversityCompletedPost Thoracotomy Pain | Thoracic Paravertebral Block | External Oblique Intercostal Plane BlockEgypt
-
Istinye UniversityRecruitingLiver Transplantation | Postoperative Pain | Recipients of Liver TransplantTurkey (Türkiye)
-
Tanta UniversityCompletedPediatrics | Transversus Abdominis Plane Block | Postoperative Analgesia | External Oblique Intercostal Plane Block | Open NephrectomyEgypt
-
Tanta UniversityCompletedNephrectomy | Transversus Abdominis Plane Block | Postoperative Analgesia | External Oblique Intercostal Plane BlockEgypt
-
Alexandria UniversityRecruitingErector Spinae Plane Block | Pediatric | External Oblique Intercostal Plane Block | Upper Abdominal SurgeriesEgypt
-
Sohag UniversityCairo UniversityNot yet recruitingPostoperative Pain | Erector Spinae Plane Block | Cholecystectomy | Regional Anesthesia