Tekirdağ Namık Kemal University
Tekirdağ, 59000, Turkey (Türkiye)
NCT Number: NCT07726550
This prospective, randomized, assessor-blinded clinical trial aims to compare the postoperative analgesic efficacy of ultrasound-guided Erector Spinae Plane Block (ESPB) and Modified External Oblique Intercostal Plane Block (EOIPB) in patients undergoing elective open nephrectomy under general anesthesia. Sixty adult patients will be randomized to receive either ESPB or EOIPB before surgical incision. All participants will receive standardized general anesthesia and postoperative multimodal analgesia. Postoperative pain scores, opioid consumption, rescue analgesic requirements, and postoperative nausea and vomiting will be assessed during the first 24 hours after surgery. The study aims to determine whether one fascial plane block technique provides superior postoperative pain control and recovery following open nephrectomy.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Tekirdağ, 59000, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultrasound-guided erector spinae plane block performed after induction of general anesthesia using 30 mL of 0.25% bupivacaine before surgical incision.
Ultrasound-guided modified external oblique intercostal plane block performed after induction of general anesthesia using 30 mL of 0.25% bupivacaine before surgical incision.
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.
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.
Time frame: 24 hours after surgery
Total postoperative tramadol consumption recorded from patient-controlled analgesia during the first 24 postoperative hours.
Time frame: 24 hours after surgery
Number of patients requiring rescue analgesia during the first 24 postoperative hours.
Time frame: 24 hours after surgery
Incidence of postoperative nausea and vomiting during the first 24 postoperative hours.
Time frame: From induction of anesthesia until the end of surgery
Intraoperative heart rate measured in beats per minute at predefined intraoperative time points.
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.
Contact information is provided by the study sponsor or research team.
Namik Kemal University
Other
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
Acronym: EOIPB-ON
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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