ESP vs. EXORA Blocks for Analgesia in Laparoscopic Cholecystectomy

NCT06900413 | Not Yet Recruiting

• 1 other identifier: KSH-01
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Erector Spinae Plane Block; Laparoscopic Cholecystectomy; Plane Block

Keywords

Erector Spinae Plane Block; exora block; laparoscopic cholecystectomy; patient-controlled analgesia; plane block

Outcome Measures

Primary Outcomes (1)

• Tramadol consumption

  Total tramadol used in the first 12 and 24 hours postoperatively.

  12 and 24 hours

Secondary Outcomes (5)

• Visual Analog Scale (VAS) for Pain Assessment

  30 minutes, 2 hours, 6 hours, 12 hours, and 24 hours after surgery

• Pinprick Sensory Block Test Results

  10 minutes, 20 minutes, and 30 minutes after the block, and 30 minutes after surgery

• Nausea and Vomiting Score (NVS)

  Within 24 hours after surgery

• Ramsay Sedation Scale (RSS)

  Within 24 hours after surgery

• Additional Analgesic Consumption

  Within 24 hours after surgery

Other Outcomes (1)

• Total Antiemetic Consumption

  Within 24 hours after surgery

Study Arms (2)

Group ESP

ACTIVE COMPARATOR

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

Group EXORA

ACTIVE COMPARATOR

The EXORA block will be performed 30 minutes before general anesthesia induction, following sedation and standard monitoring.

Procedure: Group EXORA

Interventions

Group ESP PROCEDURE

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 ESP

Group EXORA PROCEDURE

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.

Group EXORA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aycan KURTARANGİL DOĞAN: lead
• Kutahya City Hospital: collaborator

Study Officials

• Aycan KURTARANGİL DOĞAN

  Kütahya City Hospital

  PRINCIPAL INVESTIGATOR

• Ali Kaynak

  Kütahya City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aycan Kurtarangil Doğan

CONTACT

+90 (274) 229 14 00; akurtarangil@gmail.com

Ali Kaynak

CONTACT

+90 (274) 229 14 00; aakaynakk@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 28, 2025
• Study Start: September 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share