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The original EXORA block used high local anesthetic volume (50 mL total), raising concerns about local anesthetic systemic toxicity (LAST). In such a bilaterally administered regional technique, evaluating the efficacy of a reduced-volume approach is warranted to maximize patient safety.
Study Design & Population This is a prospective, randomized, double-blinded trial enrolling patients scheduled for elective laparoscopic cholecystectomy. Following informed consent, patients will be randomly allocated into two equal groups to evaluate different volumes used in a bilateral, ultrasound-guided External Oblique and Rectus Abdominis (EXORA) block.
Interventions Prior to the induction of general anesthesia, patients will receive a bilateral EXORA block using 0.25% bupivacaine.
Group E15: Will receive 15 mL of the local anesthetic on each side. Group E25: Will receive 25 mL of the local anesthetic on each side. Blinding & Allocation Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes. The block will be performed by a designated regional anesthesiologist who will not be involved in subsequent patient care. The patient, the surgical team, the intraoperative anesthesiologist, and the postoperative data collectors will remain strictly blinded to the group allocation and the volume injected.
Anesthesia & Perioperative Management Sensory block distribution will be assessed prior to surgery. All patients will receive a standardized general anesthesia protocol for induction and maintenance. Intraoperative hemodynamics will be managed according to standard institutional protocols.
Postoperative Analgesia & Monitoring Upon transfer to the Post-Anesthesia Care Unit (PACU) and throughout the first 24 hours, all patients will receive scheduled, standardized multimodal analgesia (intravenous paracetamol and ketorolac). Postoperative pain will be assessed using the 11-point Numerical Rating Scale (NRS) at rest and during movement at prespecified time points. If the dynamic NRS score is ≥ 4, intravenous morphine (2 mg) will be administered . Patients will be continuously monitored for adverse events, including postoperative nausea and vomiting (PONV), hemodynamic instability, and local anesthetic systemic toxicity (LAST), which will be managed with predefined rescue medications
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXORA 15 | Active Comparator | 15 mL of bupivacaine 0.25% administered bilaterally |
|
| EXORA 25 | Active Comparator | 25 mL of bupivacaine 0.25% administered bilaterally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXORA block 15 | Procedure | 15 mL of bupivacaine 0.25% administered bilaterally by ultrasound guided EXORA block |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dynamic numerical rating scale (NRS) score at 4 hours postoperatively. | From 0 to 10 where 0 denote no pain and 10 denote the worst pain ever experienced with cough | 4 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Static Numerical Rating scale NRS scores | From 0 to 10 where 0 denote no pain and 10 denote the worst pain ever experienced At predefined time points.(1,2,4,6,12 and 24 hours post operatively | up to 24 hours post operatively |
| Dynamic numerical rating scale NRS scores |
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Inclusion Criteria:
Exclusion Criteria:
• Patient refusal to participate.
Criteria for Withdrawal from Study Analysis (Drop-outs):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammed R Gomaa, Bch | Contact | 1097830069 | +20 | mr147@fayoum.edu.eg |
| Mohamed H Ragab, MD | Contact | 1090050298 Ext. +20 | +20 | mhr02@fayoum.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed A Hamed,, MD | Faculty of medicine, Fayoum university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fayoum University hospital | El Fayoum Qesm | Faiyum Governorate | 63514 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40161911 | Background | Okmen K, Demirel A, Dogan AK, Ertus CY. Application of EXORA block for analgesia following hand-assisted laparoscopic donor nephrectomy (HALDN). Indian J Anaesth. 2025 Mar;69(3):324-326. doi: 10.4103/ija.ija_1263_24. Epub 2025 Feb 17. No abstract available. | |
| 40230270 | Background | 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. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| EXORA block 25 | Procedure | 25 mL of bupivacaine 0.25% administered bilaterally by ultrasound guided EXORA block |
|
From 0 to 10 where 0 denote no pain and 10 denote the worst pain ever experienced With cough at predefined time points.(1,2,6,12 and 24 hours post operatively |
| up to 24 hours post operatively |
| Cumulative Static Pain Burden | calculated as the Area Under the Curve (AUC) of Static NRS scores over the 24-hour postoperative period | Up to 24h postoperatively |
| Cumulative Dynamic Pain Burden | calculated as the Area Under the Curve (AUC) of Dynamic NRS scores over the 24-hour postoperative period | Up to 24h postoperatively |
| Intraoperative Fentanyl consumption Total fentanyl in micrograms | Total fentanyl in micrograms | From induction of anesthesia until patient is transferred to postoperative care unit up to 4 hours] |
| Total cumulative consumption of intravenous morphine over the first 24 hours. | total morphine used in milligrams post operatively over 24 hours. | At 24 hours postoperatively |
| Time to first rescue analgesia | Time to first request of rescue analgesia in hours | Upon recovery from General anesthesia up to 24 hours postoperatively] |
| Sensory block distribution level (pin-prick test) | After 30 minutes of the block, assessed at. Midclavicular and Midaxillary lines from T5 to T12 level by a blinded anesthesiologist | At 30 minuets from the block |
| Quality of recovery score (QoR-15) at 24 hours. | scores range from 0 to 150, with a higher score indicating a better quality of postoperative recovery. | At 24 hours postoperatively |
| Incidence of adverse events: bradycardia, hypotension, PONV, and LAST. | Assessment of each patient looking for any of adverse effects as bradycardia ,hypotension, nausea, vomiting and LAST. | From induction of anesthesia up to 24 hours postoperatively |
| Heart rate | Heart rate measured at Baseline (T0), 3 minutes post-intubation (T1), 1 minute post-skin incision (T2), 5 minutes after pneumoperitoneum inflation (T3), At extubation (T4) and postoperatively upon arrival in the PACU (0 hours), 1, 2, 4, 6, 12, and 24 hours | Upon arrival to Operating Room until 24 hours postoperative |
| Mean arterial pressure | Mean arterial pressure measured at Baseline (T0), 3 minutes post-intubation (T1), 1 minute post-skin incision (T2), 5 minutes after pneumoperitoneum inflation (T3), At extubation (T4) and postoperatively upon arrival in the PACU (0 hours), 1, 2, 4, 6, 12, and 24 hours | Upon arrival to Operating Room until 24 hours postoperative |
| Ramsay Sedation Scale (RSS) | from 1 to 6 where 1 denotes anxious/agitated and 6 denotes deep sedation with no response to stimuli (6) assessed postoperative (at 1, 2, 4, 6, 12, and 24 hours) | up to 24 hours |
| 38287777 | Background | 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. |
| 29049119 | Background | Kumar K, Kirksey MA, Duong S, Wu CL. A Review of Opioid-Sparing Modalities in Perioperative Pain Management: Methods to Decrease Opioid Use Postoperatively. Anesth Analg. 2017 Nov;125(5):1749-1760. doi: 10.1213/ANE.0000000000002497. |
| 36345156 | Background | De Cassai A, Sella N, Geraldini F, Tulgar S, Ahiskalioglu A, Dost B, Manfrin S, Karapinar YE, Paganini G, Beldagli M, Luoni V, Ordulu BBK, Boscolo A, Navalesi P. Single-shot regional anesthesia for laparoscopic cholecystectomies: a systematic review and network meta-analysis. Korean J Anesthesiol. 2023 Feb;76(1):34-46. doi: 10.4097/kja.22366. Epub 2022 Nov 8. |
| 16371735 | Background | 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. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |