EXORA vs ESP Blocks in Laparoscopic Cholecystectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFayoum University Hospital

About this trial

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 and the ESP blocks provide superior postoperative analgesia compared to controls in patients undergoing laparoscopic cholecystectomy and that the EXORA block analgesic profile is superior to that of the ESP block.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Elective laparoscopic cholecystectomy

ASA physical status I-III

Disqualifiers

Known allergy to local anesthetics

Chronic pain or regular opioid use

Coagulopathy or anticoagulant therapy

Local infection at the block site

Trial design

Design model

Parallel

Treatments tested in this trial

  • EXORA block

    Procedure/Surgery

    in a supine position, a linear Ultrasound probe (L6-12 RS linear array transducer (6-12 MHz) on GE Healthcare Logiq P7, made in Korea) will be sagittally applied at the parasternal line, lateral to the sternum and xiphoid process. The probe will be manipulated craniocaudally to identify the 6th, 7th, and 8th costal cartilages. At the level of the 8th costal cartilage, a transverse orientation will be used to visualize the rectus abdominis muscle and the costal cartilage beneath. An 88-mm, 22-gauge needle will be directed in-plane from medial to lateral. After confirming the needle position below the rectus abdominis muscle using 4 ml isotonic saline as a hydro-dissection, 25 ml of plain bupivacaine 0.25% concentration will be injected. the spread of the local anesthetic is to be observed to advance laterally under the external oblique muscle and medially under the rectus muscle. The same procedure will be repeated on the other side.

  • Erector Spinae Plane block

    Procedure/Surgery

    in a right lateral position, the linear Ultrasound probe will be placed vertically 3 cm lateral to the midline at the level of the 7th thoracic spinal process, identifying the T7 transverse process, and the overlying erector spinae (ES) muscle. An 88-mm, 22-gauge needle will be advanced craniocaudally in-plane until hitting the T7 transverse process. After using hydro-dissection with 4 ml of isotonic saline to confirm the correct needle position, 25 ml of 0.25% bupivacaine will be administered below the erector spinae muscle. The same procedure will be repeated on the other side.

Treatment groups

114 Participants
are divided into 3 treatment groups
Group A: EXORA block groupExperimental treatment 1 intervention
Group B: ESP block groupActive comparator 1 intervention
Group C: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Total opioid consumption

Post operative nalbuphine used in the first 24 hours in milligrams

Time frame
Up to 24 hours after surgery

Secondary outcomes

1

Intraoperative Fentanyl consumption

Total fentanyl in milligrams

Time frame
From induction of anesthesia until patient is transferred to postoperative care unit up to 4 hours
2

Time needed to complete the block

In minutes

Time frame
From start of block procedure up to 1 hour
3

Sensory block distribution level (pin-prick test)

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.

Time frame
after 30 minuets from the block maneuver bilaterally
4

Heart rate

Heart rate (HR) recorded intra and post operative

Time frame
Upon arrival to Operating Room until 24 hours postoperative

Other outcomes

1

Quality of recovery (QoR-15)

scores range from 0 to 150, with a higher score indicating a better quality of postoperative recovery.

Time frame
At 24 hours postoperatively

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