An interventional study of Group ESP and Group EXORA in Erector Spinae Plane Block, Laparoscopic Cholecystectomy and Plane Block, sponsored by Aycan KURTARANGİL DOĞAN. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Aycan KURTARANGİL DOĞAN · Not applicable, Interventional, and Prevention
Patients undergoing laparoscopic cholecystectomy may experience moderate to severe postoperative pain. Effective postoperative analgesia enhances patient comfort and accelerates recovery. This study aims to compare the effects of Erector Spinae Plane (ESP) and External Oblique and Rectus Abdominis Plane (EXORA) blocks on postoperative pain management and analgesic consumption.
The study is designed as a prospective, randomized, double-blind trial. Patients will be randomly assigned to groups, and both practitioners and evaluators will be blinded to group assignments. Our hypothesis is that the EXORA block will provide superior analgesia and require less analgesic consumption compared to the ESP block. The results will be assessed in terms of postoperative pain management, patient comfort, and additional analgesic requirements.
This is the only study on the registry with Aycan KURTARANGİL DOĞAN as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Age between 18 and 65 years
Undergoing elective laparoscopic cholecystectomy
Classified as American Society of Anesthesiologists (ASA) physical status I to III
Providing written informed consent
Exclusion Criteria:
Known allergy or hypersensitivity to local anesthetics
Infection or skin lesions at the site of block application
Emergency surgical procedures
Refusal to participate in the study
Uncontrolled arterial hypertension
Uncontrolled diabetes mellitus
Mental retardation
Current use of antidepressant medications
Presence of metabolic disorders
Known bleeding diathesis
Morbid obesity (Body Mass Index > 40 kg/m²)
The ESP block will be performed approximately 30 minutes before general anesthesia induction following sedation and standard monitoring. All block procedures will be conducted under sterile conditions, with skin preparation using dermol (%70 Isopropyl Alcohol, %2 Chlorhexidine Gluconate) and the ultrasound probe covered with a sterile drape.
Procedure: Group ESP
The EXORA block will be performed 30 minutes before general anesthesia induction, following sedation and standard monitoring.
Procedure: Group EXORA
Experienced anesthesiologists with at least five years of expertise in regional anesthesia will perform the blocks under ultrasound guidance. A 4.0-12.0 MHz linear ultrasound probe (Affiniti 50; Philips) will be used. The ESP block will be applied at the T8 level on the right side, using an in-plane approach, while the patient is in a sitting position. The probe will be placed 2-3 cm lateral to the vertebra in a sagittal position to visualize the erector spinae muscle and transverse processes. A 22G, 100 mm block needle (Stimuplex® Ultra, Braun, Germany) will be advanced in a craniocaudal direction. The correct needle position will be confirmed by injecting 0.5-1 mL of isotonic NaCl and observing the spread via hydrodissection. Finally, 0.3 mL/kg of 0.25% bupivacaine will be administered, ensuring cranial and caudal spread of the local anesthetic.
Experienced anesthesiologists with at least five years of expertise in regional anesthesia will administer the blocks under ultrasound guidance. A 4.0-12.0 MHz linear ultrasound probe will be placed laterally to the xiphoid process on the parasternal line in a sagittal position. The probe will be moved craniocaudally to identify the 6th rib and further advanced caudally to locate the 8th rib. Once the rectus abdominis muscle and 8th costal cartilage are identified, a 22G, 100 mm block needle will be used to administer 0.3 mL/kg of 0.25% bupivacaine. The correct spread of the local anesthetic will be confirmed via ultrasound.
Tramadol consumption
Total tramadol used in the first 12 and 24 hours postoperatively.
Time frame: 12 and 24 hours
Visual Analog Scale (VAS) for Pain Assessment
Postoperative pain will be assessed using the Visual Analog Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate a worse outcome (more pain). Units on a scale (0-10)
Time frame: 30 minutes, 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours after surgery
Pinprick Sensory Block Test Results
Sensory block efficacy will be evaluated using the pinprick test at specified time intervals. The presence or absence of sensory block will be recorded. Binary (Block present / Block absent)
Time frame: 10 minutes, 20 minutes, and 30 minutes after the block, and 30 minutes after surgery
Nausea and Vomiting Score (NVS)
Postoperative nausea and vomiting will be evaluated using the Nausea and Vomiting Scale (NVS), which includes: 1. = No nausea, 2. = Mild nausea, 3. = Severe nausea, 4. = Vomiting present. Higher scores indicate a worse outcome. Units on a scale (1-4)
Time frame: Within 24 hours after surgery
Ramsay Sedation Scale (RSS)
Postoperative sedation will be assessed using the Ramsay Sedation Scale (RSS), which includes: 1. = Anxious, agitated, or restless 2. = Cooperative, oriented, and tranquil 3. = Responds to commands only 4. = Brisk response to auditory stimulus 5. = Sluggish response to auditory stimulus 6. = No response Higher scores indicate a deeper level of sedation. Units on a scale (1-6)
Time frame: Within 24 hours after surgery
Additional Analgesic Consumption
The total amount of additional analgesics administered postoperatively will be recorded. Milligrams (mg)
Time frame: Within 24 hours after surgery
Total Antiemetic Consumption
The total amount of antiemetic medication administered within 24 hours postoperatively will be recorded. Milligrams (mg)
Time frame: Within 24 hours after surgery
Plan to share: No
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