Pain, PostoperativeNCT07507799
Low Versus Standard Volume EXORA Block in Laparoscopic Cholecystectomy
A study testing EXORA block 15 and EXORA block 25 in people with Pain, Postoperative and Post Operative Analgesia, run by Fayoum University Hospital at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative, Post Operative Analgesia
- What is being tested?
- EXORA block 15 and EXORA block 25
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Apr 2026to 2 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- American Society of Anesthesiologists (ASA) physical status I or II.
- Scheduled for elective laparoscopic cholecystectomy under general anesthesia.
Who cannot join
- • Patient refusal to participate.
- Obese patients with a body mass index of more than 35 kg/m2.
- Known cognitive impairment or use of psychiatric drugs
- Known allergy to local anesthetics
- Infection at the needle insertion site.
- Coagulopathy, or bleeding disorders.
Show all 12Show fewer
- Pregnancy
- History of chronic pain or chronic opioid use.
- Previous major upper abdominal surgery (which alters the fascial planes and anatomy).
- Criteria for Withdrawal from Study Analysis (Drop-outs):
- Conversion to open cholecystectomy during surgery.
- Failed EXORA block
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Fayoum University hospital
El Fayoum Qesm, Faiyum Governorate, 63514
Mohamed A Hamed, MD, 1010509736 ext. +20, mah07@fayoum.edu.eg
Mohamed H Ragab, MD, 1090050298 ext. +20, mhr02@fayoum.edu.eg
About this study
Official title: Analgesic Efficacy of Low-Volume Versus Standard-Volume 0.25% Bupivacaine for Ultrasound-Guided External Oblique and Rectus Abdominis Plane Block in Laparoscopic Cholecystectomy, A Randomized Non-Inferiority Trial
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.
Read the detailed description
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
- Conditions
- Pain, Postoperative, Post Operative Analgesia
- Being tested
- EXORA block 15, EXORA block 25
- Keywords
- EXORA, analgesic efficacy, low volume, laparoscopic cholecystectomy
- 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 block 15Procedure or surgery
15 mL of bupivacaine 0.25% administered bilaterally by ultrasound guided EXORA block
EXORA block 25Procedure or surgery
25 mL of bupivacaine 0.25% administered bilaterally by ultrasound guided EXORA block
| Study group | Role | What they receive |
|---|---|---|
| EXORA 15 | Active comparator | 15 mL of bupivacaine 0.25% administered bilaterally Receives: Procedure: EXORA block 15 |
| EXORA 25 | Active comparator | 25 mL of bupivacaine 0.25% administered bilaterally Receives: Procedure: EXORA block 25 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 hours after surgery
Secondary outcomes (13)
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
Measured: up to 24 hours post operatively
Dynamic numerical rating scale NRS scores
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
Measured: 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
Measured: 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
Measured: Up to 24h postoperatively
Intraoperative Fentanyl consumption Total fentanyl in micrograms
Total fentanyl in micrograms
Measured: 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.
Measured: At 24 hours postoperatively
Time to first rescue analgesia
Time to first request of rescue analgesia in hours
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start12 Apr 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion2 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Hamed, Fayoum University Hospital
- Investigators
- Mohamed A Hamed,, MD, Principal investigator, Faculty of medicine, Fayoum university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507799
- Sponsor's protocol ID
- M 871
- Status last verified
- Aug 2026
- First submitted
- 25 Mar 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40161911Okmen 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 40230270Fernandez 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 38287777Kumar 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.
PubMed 29049119De 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.
PubMed 36345156Ekstein 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Low-Volume Versus Standard-Volume 0.25% Bupivacaine for Ultrasound-Guided External Oblique and Rectus Abdominis Plane Block in Laparoscopic Cholecystectomy, A Randomized Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT07507799
- Acronym / sponsor ID
- M 871
- Conditions
- Pain, Postoperative, Post Operative Analgesia
- Keywords
- EXORA, analgesic efficacy, low volume, laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 12 Apr 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 2 Jan 2027 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXORA 15 | Active comparator | Procedure: EXORA block 1515 mL of bupivacaine 0.25% administered bilaterally |
| EXORA 25 | Active comparator | Procedure: EXORA block 2525 mL of bupivacaine 0.25% administered bilaterally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status I or II.
- Scheduled for elective laparoscopic cholecystectomy under general anesthesia.
Key exclusion criteria (12 listed)
- • Patient refusal to participate.
- Conversion to open cholecystectomy during surgery.
- Failed EXORA block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXORA block 1515 mL of bupivacaine 0.25% administered bilaterally by ultrasound guided EXORA block | Procedure or surgery | EXORA 15 |
| EXORA block 2525 mL of bupivacaine 0.25% administered bilaterally by ultrasound guided EXORA block | Procedure or surgery | EXORA 25 |
Primary outcome
Dynamic numerical rating scale (NRS) score at 4 hours postoperatively.
Time frame: 4 hours after surgery
From 0 to 10 where 0 denote no pain and 10 denote the worst pain ever experienced with cough
13 secondary outcomes
Static Numerical Rating scale NRS scores
Time frame: up to 24 hours post operatively
Dynamic numerical rating scale NRS scores
Time frame: up to 24 hours post operatively
Cumulative Static Pain Burden
Time frame: Up to 24h postoperatively
Cumulative Dynamic Pain Burden
Time frame: Up to 24h postoperatively
Intraoperative Fentanyl consumption Total fentanyl in micrograms
Time frame: 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.
Time frame: At 24 hours postoperatively
Time to first rescue analgesia
Time frame: Upon recovery from General anesthesia up to 24 hours postoperatively]
Sensory block distribution level (pin-prick test)
Time frame: At 30 minuets from the block
Quality of recovery score (QoR-15) at 24 hours.
Time frame: At 24 hours postoperatively
Incidence of adverse events: bradycardia, hypotension, PONV, and LAST.
Time frame: From induction of anesthesia up to 24 hours postoperatively
Heart rate
Time frame: Upon arrival to Operating Room until 24 hours postoperative
Mean arterial pressure
Time frame: Upon arrival to Operating Room until 24 hours postoperative
Ramsay Sedation Scale (RSS)
Time frame: up to 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Background: PubMed 40161911Okmen 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.
- Background: PubMed 40230270Okmen 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.
- Background: PubMed 38287777Fernandez 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.
- Background: PubMed 29049119Kumar 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.
- Background: PubMed 36345156De 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.
- Background: PubMed 16371735Ekstein 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.
- Individual participant dataSharing planned: No
Related trials for Pain, Postoperative
RecruitingPhase 4
The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery
Pain, Post Operative Analgesia
Not yet recruitingPhase 4
Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Sphenopalatine Ganglion Block for Functional Endoscopic Sinus Surgery
Post Operative Pain, Emergence Agitation
Recruiting
Anterior Nerves of the Knee Block Versus Femoral Nerve Block for Knee Arthroscopy
Postoperative Pain, Knee Arthroscopy
Active, not recruiting
THE EFFECT OF FILLING MATERIAL AND PLACEMENT TECHNIQUE ON POSTOPERATIVE PAIN IN NON-SURGICAL ENDODONTIC RETREATMENT: A RANDOMIZED CLINICAL TRIAL
Retreatment, Endodontic Diseases
Recruiting
The Effect of Virtual Reality Headsets on Pain, Anxiety, Patient Satisfaction, and Physiological Parameters in Patients Undergoing Open-Heart Surgery
Pain After Surgery, Pain and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed A Hamed,, MD principal investigator
Faculty of medicine, Fayoum university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXORA block 15 and EXORA block 25 in people with Pain, Postoperative and Post Operative Analgesia, 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 12 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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed R Gomaa, Bch (1097830069 ext. +20, mr147@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic numerical rating scale (NRS) score at 4 hours postoperatively. (time frame: 4 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 NCT07507799, which also lists 6 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.