- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07726550
Modified External Oblique Intercostal Plane Block Versus Erector Spinae Plane Block for Open Nephrectomy (EOIPB-ON)
Comparison of Modified External Oblique Intercostal Plane Block and Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Open Nephrectomy: A Prospective Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Open nephrectomy is associated with substantial postoperative pain that may impair recovery, delay mobilization, and increase opioid consumption. Regional anesthesia techniques have become important components of multimodal analgesia strategies aimed at improving postoperative outcomes while minimizing opioid-related adverse effects.
The erector spinae plane block (ESPB) and modified external oblique intercostal plane block (EOIPB) are ultrasound-guided fascial plane blocks that have demonstrated effectiveness in providing thoracoabdominal analgesia. However, evidence directly comparing these techniques in patients undergoing open nephrectomy remains limited.
This study is a prospective, randomized, controlled, assessor-blinded clinical trial conducted at a single tertiary academic center. Sixty patients aged 18 to 65 years with ASA physical status I-II who are scheduled for elective open nephrectomy will be enrolled and randomized in a 1:1 ratio to one of two study groups.
Participants assigned to the ESPB group will receive an ultrasound-guided erector spinae plane block with 30 mL of 0.25% bupivacaine after induction of general anesthesia and before surgical incision. Participants assigned to the EOIPB group will receive an ultrasound-guided modified external oblique intercostal plane block using the same volume and concentration of local anesthetic.
All patients will receive standardized general anesthesia, postoperative intravenous patient-controlled analgesia with tramadol, scheduled paracetamol, and rescue analgesics according to institutional protocols. Patients will be followed in the post-anesthesia care unit and at postoperative 2, 6, 12, and 24 hours.
The primary objective is to compare postoperative pain intensity between the two groups during the first 24 postoperative hours. Secondary objectives include comparison of opioid consumption, rescue analgesic requirements, postoperative nausea and vomiting, and perioperative hemodynamic parameters.
The results of this study may help identify the optimal regional analgesia technique for patients undergoing open nephrectomy and contribute to enhanced postoperative recovery.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Onur Baran, MD
- Phone Number: +90 539 342 25 82
- Email: dronurbaran@hotmail.com
Study Locations
-
-
Tekirdağ
-
Tekirdağ, Tekirdağ, Turkey (Türkiye), 59000
- Tekirdağ Namık Kemal University
-
Contact:
- Onur Baran, Associate Professor
- Phone Number: +90 539 342 25 82
- Email: dronurbaran@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 65 years.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Scheduled for elective open nephrectomy.
- Able and willing to provide written informed consent.
- Willing to comply with study procedures.
Exclusion Criteria:
- Refusal to participate or inability to provide informed consent.
- Emergency surgery.
- Body mass index (BMI) greater than 35 kg/m².
- Known allergy or hypersensitivity to local anesthetics.
- Infection at the planned block insertion site.
- Coagulopathy or ongoing anticoagulant therapy.
- Pregnancy or breastfeeding.
- Prisoners or other vulnerable populations unable to provide independent consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ESPB Group
Participants will receive an ultrasound-guided erector spinae plane block with 30 mL of 0.25% bupivacaine after induction of general anesthesia and before surgical incision.
Standardized general anesthesia and postoperative multimodal analgesia will be provided to all participants.
|
Ultrasound-guided erector spinae plane block performed after induction of general anesthesia using 30 mL of 0.25% bupivacaine before surgical incision.
|
|
Experimental: EOIPB Group
Participants will receive an ultrasound-guided modified external oblique intercostal plane block with 30 mL of 0.25% bupivacaine after induction of general anesthesia and before surgical incision.
Standardized general anesthesia and postoperative multimodal analgesia will be provided to all participants.
|
Ultrasound-guided modified external oblique intercostal plane block performed after induction of general anesthesia using 30 mL of 0.25% bupivacaine before surgical incision.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity at rest
Time Frame: 0, 2, 6, 12, and 24 hours after surgery
|
Postoperative pain intensity will be assessed at rest using the 11-point Numeric Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
|
0, 2, 6, 12, and 24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity during movement
Time Frame: 0, 2, 6, 12, and 24 hours after surgery
|
Postoperative pain intensity will be assessed during movement using the 11-point Numeric Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
|
0, 2, 6, 12, and 24 hours after surgery
|
|
Total Opioid Consumption
Time Frame: 24 hours after surgery
|
Total postoperative tramadol consumption recorded from patient-controlled analgesia during the first 24 postoperative hours.
|
24 hours after surgery
|
|
Rescue Analgesic Requirement
Time Frame: 24 hours after surgery
|
Number of patients requiring rescue analgesia during the first 24 postoperative hours.
|
24 hours after surgery
|
|
Postoperative Nausea and Vomiting
Time Frame: 24 hours after surgery
|
Incidence of postoperative nausea and vomiting during the first 24 postoperative hours.
|
24 hours after surgery
|
|
Heart Rate
Time Frame: From induction of anesthesia until the end of surgery
|
Intraoperative heart rate measured in beats per minute at predefined intraoperative time points.
|
From induction of anesthesia until the end of surgery
|
|
Mean Arterial Pressure
Time Frame: From induction of anesthesia until the end of surgery
|
Intraoperative mean arterial pressure measured in millimeters of mercury at predefined intraoperative time points.
|
From induction of anesthesia until the end of surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TNKU-EOIPB003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
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