ESP vs. EXORA Blocks for Analgesia in Laparoscopic Cholecystectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAycan KURTARANGİL DOĞAN
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Group ESP
Procedure/SurgeryExperienced 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.
Group EXORA
Procedure/SurgeryExperienced 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.
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Group ESPActive comparator 1 intervention
Group B: Group EXORAActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Tramadol consumption
Total tramadol used in the first 12 and 24 hours postoperatively.
Time frame
12 and 24 hoursSecondary outcomes
1
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, 6 hours, 12 hours, and 24 hours after surgery2
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 surgery3
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 surgery4
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 surgeryOther outcomes
1
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 surgeryLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Aycan KURTARANGİL DOĞAN
Lead sponsor
Kutahya City Hospital
Sponsor institution
Kutahya City Hospital
Collaborator
Source ClinicalTrials.gov
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