AzTrials
AzTrials

Postoperative PainNCT07187310

EXORA vs ESP Blocks in Laparoscopic Cholecystectomy

A study testing EXORA block and Erector Spinae Plane block in people with Postoperative Pain, run by Fayoum University Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Postoperative Pain
What is being tested?
EXORA block and Erector Spinae Plane block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteEgypt
Study dates
30 Dec 2025to 6 Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Elective laparoscopic cholecystectomy
  • ASA physical status I-III

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Fayoum University hospital

    El Fayoum Qesm, Faiyum Governorate, 63514

Other trials in Egypt

About this study

Official title: The Analgesic Efficacy of EXORA Block Versus Erector Spinae Plane Block in Patients Undergoing Laparoscopic Cholecystectomy Under General Anesthesia

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.

Read the 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 October 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. Both static (at rest) and dynamic (with movement) visual analogue scale (VAS) 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.

Being tested
EXORA block, Erector Spinae Plane block
Keywords
EXORA block, Erector spinae Plain block, Regional Anesthesia for Laparoscopic Cholecystectomy, Postoperative pain management in abdominal surgeries
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EXORA blockProcedure or 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 blockProcedure or 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.

Study groups in NCT07187310
Study groupRoleWhat they receive
EXORA block groupExperimentalGroup A (EXORA Block Group): Patients will receive bilateral EXORA blocks.
Receives: Procedure: EXORA block
ESP block groupActive comparatorGroup B (ESP Block Group): Patients will receive bilateral ESP blocks.
Receives: Procedure: Erector Spinae Plane block
control groupNo interventionGroup C (Control Group): patients will not receive any block, only standard care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total opioid consumption

    Post operative nalbuphine used in the first 24 hours in milligrams

    Measured: Up to 24 hours after surgery

Secondary outcomes (9)
  1. Intraoperative Fentanyl consumption

    Total fentanyl in milligrams

    Measured: 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

    Measured: 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.

    Measured: after 30 minuets from the block maneuver bilaterally

  4. Heart rate

    Heart rate (HR) recorded intra and post operative

    Measured: Upon arrival to Operating Room until 24 hours postoperative

  5. Blood pressure

    Mean Arterial Pressure (MAP)

    Measured: Upon arrival to Operating Room until 24 hours postoperative

  6. Postoperative pain scores by Visual Analogue Scale (VAS)

    score from 0 to 10 where 0 indicates no pain and 10 indicates the worst imaginable pain

    Measured: From patient discharge to postoperative anesthesia care unit 24 hours postoperatively

  7. Rescue analgesia

    Time to first request of rescue analgesia

    Measured: Upon recovery from General anesthesia up to 24 h postoperatively

  8. Incidence of opioid-related side effects

    Assessment of each patient looking for any of the side effects of opioids as nausea, vomiting, sedation.

    Measured: From induction of anesthesia up to 24 h postoperatively

  9. Incidence of Block-related side effects

    any Block-related side effects as Local anesthetic systemic toxicity, bleeding, pneumothorax, local infection.

    Measured: From the time just after giving the block up to 24 h postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2025
  2. Study start30 Dec 2025
  3. Primary completion6 Aug 2026
  4. Study completion6 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07187310
Sponsor's protocol ID
M829
Status last verified
Sep 2026
First submitted
18 Sep 2025
Last updated
2 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Asad U, Wang CF, Jones MW. Laparoscopic Cholecystectomy. 2025 Jul 2. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK448145/

    PubMed 28846328
  • Roy DK, Sheikh R. A Systematic Review and Meta-Analysis of the Outcomes of Laparoscopic Cholecystectomy Compared to the Open Procedure in Patients with Gallbladder Disease. Avicenna J Med. 2024 Feb 1;14(1):3-21. doi: 10.1055/s-0043-1777710. eCollection 2024 Jan.

    PubMed 38694141
  • Ekstein P, Szold A, Sagie B, Werbin N, Klausner JM, Weinbroum AA. Laparoscopic surgery may be associated with severe pain and high analgesia requirements in the immediate postoperative period. Ann Surg. 2006 Jan;243(1):41-6. doi: 10.1097/01.sla.0000193806.81428.6f.

    PubMed 16371735
  • Dua A, Aziz A, Desai SS, McMaster J, Kuy S. National Trends in the Adoption of Laparoscopic Cholecystectomy over 7 Years in the United States and Impact of Laparoscopic Approaches Stratified by Age. Minim Invasive Surg. 2014;2014:635461. doi: 10.1155/2014/635461. Epub 2014 Mar 20.

    PubMed 24790759
  • Urman RD, Khanna AK, Bergese SD, Buhre W, Wittmann M, Le Guen M, Overdyk FJ, Di Piazza F, Saager L. Postoperative opioid administration characteristics associated with opioid-induced respiratory depression: Results from the PRODIGY trial. J Clin Anesth. 2021 Jun;70:110167. doi: 10.1016/j.jclinane.2021.110167. Epub 2021 Jan 22.

    PubMed 33493688
  • Lohmoller K, Carstensen V, Pogatzki-Zahn EM, Freys SM, Weibel S, Schnabel A. Regional anaesthesia for postoperative pain management following laparoscopic, visceral, non-oncological surgery a systematic review and meta-analysis. Surg Endosc. 2024 Apr;38(4):1844-1866. doi: 10.1007/s00464-023-10667-w. Epub 2024 Feb 2.

    PubMed 38307961
  • Sethi D, Garg G. Evaluation of postoperative analgesia of erector spinae plane block in elective laparoscopic cholecystectomy: a randomized controlled trial. Turk J Anaesthesiol Reanim. 2021 Dec;49(6):432-438. doi: 10.5152/TJAR.2021.878.

    PubMed 35110021
  • Altiparmak B, Korkmaz Toker M, Uysal AI, Kuscu Y, Gumus Demirbilek S. Ultrasound-guided erector spinae plane block versus oblique subcostal transversus abdominis plane block for postoperative analgesia of adult patients undergoing laparoscopic cholecystectomy: Randomized, controlled trial. J Clin Anesth. 2019 Nov;57:31-36. doi: 10.1016/j.jclinane.2019.03.012. Epub 2019 Mar 6.

    PubMed 30851501
  • Yang X, Zhang Y, Chen Y, Xu M, Lei X, Fu Q. Analgesic effect of erector spinae plane block in adults undergoing laparoscopic cholecystectomy: a systematic review and meta-analysis of randomized controlled trials. BMC Anesthesiol. 2023 Jan 6;23(1):7. doi: 10.1186/s12871-023-01969-6.

    PubMed 36609244
  • Fernandez Martin MT, Lopez Alvarez S, Valdes-Vilches LF. EXORA block: a new approach for laparoscopic cholecystectomy analgesia? Minerva Anestesiol. 2024 May;90(5):462-463. doi: 10.23736/S0375-9393.23.17863-1. Epub 2024 Jan 29. No abstract available.

    PubMed 38287777
  • Okmen K, Yildiz DK, Ulker GK. Evaluation of the efficacy of M-TAPA and EXORA block application for analgesia after laparoscopic cholecystectomy: a prospective, single-blind, observational study. Korean J Anesthesiol. 2025 Aug;78(4):361-368. doi: 10.4097/kja.24563. Epub 2025 Apr 15.

    PubMed 40230270

Questions about this trial

What is this clinical trial studying?

A study testing EXORA block and Erector Spinae Plane block in people with Postoperative Pain, run by Fayoum University Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total opioid consumption (time frame: Up to 24 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07187310, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026; AzTrials last refreshed its copy on 2 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in