Open Nephrectomy, Postoperative Pain
Conditions
Keywords
Erector Spinae Plane Block, External Oblique Intercostal Plane Block, Regional Anesthesia, EOIPB, ESPB, Postoperative Analgesia, Open Nephrectomy, Multimodal Analgesia, Pain Management
Brief summary
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.
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.
Interventions
PROCEDUREErector Spinae Plane Block
Ultrasound-guided erector spinae plane block performed after induction of general anesthesia using 30 mL of 0.25% bupivacaine before surgical incision.
PROCEDUREModified External Oblique Intercostal Plane Block
Ultrasound-guided modified external oblique intercostal plane block performed after induction of general anesthesia using 30 mL of 0.25% bupivacaine before surgical incision.
Sponsors
Namik Kemal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants will be unaware of group allocation because all block procedures will be performed after induction of general anesthesia. Postoperative outcome assessments will be conducted by a researcher who is blinded to treatment allocation.
Intervention model description
Participants will be randomized in a 1:1 ratio to receive either ultrasound-guided erector spinae plane block (ESPB) or modified external oblique intercostal plane block (EOIPB) before surgical incision. Both groups will receive standardized general anesthesia and postoperative multimodal analgesia.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity at rest | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity during movement | 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. |
| Total Opioid Consumption | 24 hours after surgery | Total postoperative tramadol consumption recorded from patient-controlled analgesia during the first 24 postoperative hours. |
| Rescue Analgesic Requirement | 24 hours after surgery | Number of patients requiring rescue analgesia during the first 24 postoperative hours. |
| Postoperative Nausea and Vomiting | 24 hours after surgery | Incidence of postoperative nausea and vomiting during the first 24 postoperative hours. |
| Heart Rate | From induction of anesthesia until the end of surgery | Intraoperative heart rate measured in beats per minute at predefined intraoperative time points. |
| Mean Arterial Pressure | From induction of anesthesia until the end of surgery | Intraoperative mean arterial pressure measured in millimeters of mercury at predefined intraoperative time points. |
Countries
Turkey (Türkiye)
Contacts
CONTACTOnur Baran, MD
Outcome results
None listed