ESP vs. EXORA Blocks for Analgesia in Laparoscopic Cholecystectomy

Comparison of the Efficacy of Erector Spinae Plane (ESP) and External Oblique and Rectus Abdominis Plane (EXORA) Blocks in Laparoscopic Cholecystectomy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Laparoscopic Cholecystectomy; Erector Spinae Plane Block; Plane Block
• Intervention / Treatment: Procedure: Group ESP; Procedure: Group EXORA

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aycan Kurtarangil Doğan; Phone Number: +90 (274) 229 14 00; Email: akurtarangil@gmail.com
• Study Contact Backup: Name: Ali Kaynak; Phone Number: +90 (274) 229 14 00; Email: aakaynakk@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.
Active Comparator: Group EXORA; 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tramadol consumption	Total tramadol used in the first 12 and 24 hours postoperatively.	12 and 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	30 minutes, 2 hours, 6 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)	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: = No nausea,; = Mild nausea,; = Severe nausea,; = Vomiting present. Higher scores indicate a worse outcome. Units on a scale (1-4)	Within 24 hours after surgery
Ramsay Sedation Scale (RSS)	Postoperative sedation will be assessed using the Ramsay Sedation Scale (RSS), which includes: = Anxious, agitated, or restless; = Cooperative, oriented, and tranquil; = Responds to commands only; = Brisk response to auditory stimulus; = Sluggish response to auditory stimulus; = No response Higher scores indicate a deeper level of sedation. Units on a scale (1-6)	Within 24 hours after surgery
Additional Analgesic Consumption	The total amount of additional analgesics administered postoperatively will be recorded. Milligrams (mg)	Within 24 hours after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Antiemetic Consumption	The total amount of antiemetic medication administered within 24 hours postoperatively will be recorded. Milligrams (mg)	Within 24 hours after surgery

Collaborators and Investigators

• Sponsor: Aycan KURTARANGİL DOĞAN
• Collaborators: Kutahya City Hospital
• Investigators: Principal Investigator: Aycan KURTARANGİL DOĞAN, Kutahya City Hospital; Principal Investigator: Ali Kaynak, Kutahya City Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): March 28, 2025

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: patient-controlled analgesia; laparoscopic cholecystectomy; Erector Spinae Plane Block; plane block; exora block
• Other Study ID Numbers: KSH-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No