ESP vs. EXORA Blocks for Analgesia in Laparoscopic Cholecystectomy
NCT ID: NCT06900413
Last Updated: 2025-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
56 participants
INTERVENTIONAL
2025-09-30
2026-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Group ESP
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.
Group ESP
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.
Group EXORA
The EXORA block will be performed 30 minutes before general anesthesia induction, following sedation and standard monitoring.
Group EXORA
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.
Interventions
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Group ESP
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.
Group EXORA
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.
Eligibility Criteria
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Inclusion Criteria
Undergoing elective laparoscopic cholecystectomy
Classified as American Society of Anesthesiologists (ASA) physical status I to III
Providing written informed consent
Exclusion Criteria
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)
18 Years
65 Years
ALL
No
Sponsors
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Kutahya City Hospital
OTHER
Aycan KURTARANGİL DOĞAN
OTHER
Responsible Party
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Aycan KURTARANGİL DOĞAN
Principal Investigator
Principal Investigators
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Aycan KURTARANGİL DOĞAN
Role: PRINCIPAL_INVESTIGATOR
Kütahya City Hospital
Ali Kaynak
Role: PRINCIPAL_INVESTIGATOR
Kütahya City Hospital
Central Contacts
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Other Identifiers
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KSH-01
Identifier Type: -
Identifier Source: org_study_id
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