EXORA vs ESP Blocks in Laparoscopic Cholecystectomy

Not Applicable

Not yet recruiting

• Conditions: Postoperative Pain

• Registration Number: NCT07187310
• Lead Sponsor: Fayoum University Hospital

Brief Summary

Laparoscopic cholecystectomy is still considered the gold standard for the surgical management of gallbladder disease due to its minimally invasive nature, shorter recovery time, and reduced postoperative complications. Despite these advantages, patients frequently experience moderate to severe postoperative pain, particularly in the early postoperative period, which can impede recovery, delay mobilization, and increase opioid consumption. Excessive opioid use after laparoscopic cholecystectomy is associated with several drawbacks, including nausea, vomiting, sedation, and delayed recovery. It also increases the risk of respiratory depression, especially in vulnerable patients, and may contribute to long-term opioid dependence. These risks highlight the importance of opioid-sparing strategies such as regional anesthesia techniques to improve patient outcomes and enhance recovery. Regional anesthesia techniques have emerged as essential components of multimodal analgesia strategies in abdominal surgeries. Among them, the Erector Spinae Plane (ESP) Block has gained popularity due to its relative ease of administration and favorable safety profile.

Recently, a novel fascial plane block known as the EXORA block has been introduced as a promising alternative for abdominal wall analgesia. This block, which targets a different anatomical plane, is postulated to provide comparable or superior analgesic efficacy to traditional methods while maintaining safety and simplicity in execution. Given the ongoing pursuit of optimal analgesia with minimal side effects, it is essential to compare emerging techniques, such as the EXORA block, with established methods like the ESP block.

The authors hypothesize that the EXORA block provides postoperative analgesia in the anterolateral abdomen as effective as the erector spinae plane (ESP) block in patients undergoing laparoscopic cholecystectomy.

Detailed Description

Following the tenets of the Declaration of Helsinki and the Consolidated Standards of Reporting Trials (CONSORT) 2025-updated statement, this prospective, randomized, double-blinded, controlled clinical trial will be conducted at Fayoum University Hospital (FUH) starting from November 2025 until the sample size is reached.

After obtaining approval from the local institutional ethics committee at Fayoum University Hospital (FUH) and registering the trial on ClinicalTrials.gov, all patients scheduled for elective cholecystectomy at FUH will sign a detailed informed consent form after fulfilling the eligibility criteria.

Patients will be randomly assigned to three equal groups with an allocation ratio of 1:1:1 (n=35) using computer-generated random numbers that will be sealed in a closed opaque envelope, opened by the anesthesiologist responsible for administering the ultrasound-guided block preoperatively

* Group A (EXORA Block Group): Patients will receive bilateral EXORA blocks.

* Group B (ESP Block Group): Patients will receive bilateral ESP blocks.

* Group C (Control Group): patients will not receive any block, only standard care.

Preoperatively, all patients will be assessed and investigated by complete blood count, Prothrombin time and concentration, kidney and liver functions. Additional investigations, such as serum electrolytes, ECG, ECHO, etc., will be ordered upon individual patient assessment.

All blocks will be performed by an anesthesiologist experienced in regional blocks preoperatively in a separate block room under strict aseptic conditions using ultrasound guidance after applying standard monitoring (pulse oximetry, non-invasive blood pressure, and electrocardiogram) and administering a sedative dose of intravenous midazolam (0.03 mg/kg).

For both groups A and B, sensory block will be assessed by a blinded anesthesiologist after 30 minutes from the block maneuver bilaterally from the distribution of the fifth Thoracic dermatome (T5) down to the level of the twelfth thoracic dermatome (T12). This will be accomplished using a pinprick with a blunt 20-G needle on a two-point scale, where 0 indicates the presence of sensation and 1 indicates numbness or absence of sensation in reference to sensation in the shoulder region. If no sensory loss is observed, the patient will be excluded from the study.

All patients will then be transferred to the operating room, handed over to the attending anesthesiologist who is blinded to group allocation and is responsible for further patient management. standard monitoring will be reapplied, and then general anesthesia will be induced using propofol (2 mg/kg), atracurium (0.5 mg/kg), and fentanyl (2 μg/kg). Anesthesia will be maintained with intermittent intravenous atracurium (0.1 mg/kg boluses) and an isoflurane inhalation in an oxygen and air mixture. An intravenous Ketorolac (30 mg), Nalbuphine (10 mg), and Ondansetron 8 mg will be administered approximately 30 minutes before the end of the operation.

After discharge to the ward, paracetamol 1g /8 hours and ketorolac 30 mg/12 hours will be administered to all patients. Visual analogue scale will be assessed at 1,2, 4, 6, 12, and 24 hours (where 0 denotes no pain, and 10 represents the most intense pain ever experienced), and if the VAS score is equal to or higher than 4, a rescue analgesic dose of nalbuphine 5 mg will be administered. The patient's pain will be evaluated using both static (at rest) and dynamic (with movement) Visual Analog Scale (VAS) at 1, 4, 8, 16, and 24 hours postoperatively. Patients with VAS scores of 4 or higher will receive Nalbuphine (5 mg) for rescue analgesia.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-18
• Study First Submitted QC: 2025-09-18
• Last Update Submitted: 2025-09-18
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22
• Study Start: 2025-10-01
• Primary Completion: 2026-02-28
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Elective laparoscopic cholecystectomy
• ASA physical status I-III

Exclusion Criteria

• Known allergy to local anesthetics
• Chronic pain or regular opioid use
• Coagulopathy or anticoagulant therapy
• Local infection at the block site
• BMI more than 35 kg/m2
• Neurological or psychiatric disorders
• Refusal to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total opioid consumption	Up to 24 hours after surgery	Post operative nalbuphine used in the first 24 hours in milligrams

Secondary Outcome Measures

Name	Time	Method
Intraoperative Fentanyl consumption	From induction of anesthesia until patient is transferred to postoperative care unit up to 4 hours	Total fentanyl in milligrams
Time needed to complete the block	From start of block procedure up to 1 hour	In minutes
Sensory block distribution level (pin-prick test)	after 30 minuets from the block maneuver bilaterally	sensory block will be assessed by a blinded anesthesiologist after 30 minutes from the block maneuver bilaterally from the distribution of the fifth Thoracic dermatome (T5) down to the level of the twelfth thoracic dermatome (T12). This will be accomplished using a pinprick with a blunt 20-G needle on a two-point scale, where 0 indicates the presence of sensation and 1 indicates numbness or absence of sensation in reference to sensation in the shoulder region.
Heart rate	Upon arrival to Operating Room until 24 hours postoperative	Heart rate (HR) recorded intra and post operative
Blood pressure	Upon arrival to Operating Room until 24 hours postoperative	Mean Arterial Pressure (MAP)
Postoperative pain scores	From patient discharge to postoperative anesthesia care unit 24 hours postoperatively	postoperative pain will be measured using the static and dynamic Visual Analogue Scale (VAS).
Rescue analgesia	Upon recovery from General anesthesia up to 24 h postoperatively	Time to first request of rescue analgesia
Incidence of opioid-related side effects	From induction of anesthesia up to 24 h postoperatively	Assessment of each patient looking for any of the side effects of opioids as nausea, vomiting, sedation.
Incidence of Block-related side effects	From the time just after giving the block up to 24 h postoperatively	any Block-related side effects as Local anesthetic systemic toxicity, bleeding, pneumothorax, local infection.

Trial Locations

Locations (1)

Fayoum University hospital; 🇪🇬 El Fayoum Qesm, Faiyum Governorate, Egypt