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NCT Number: NCT07507799

Low Versus Standard Volume EXORA Block in Laparoscopic Cholecystectomy

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fayoum University hospital

El Fayoum Qesm, Faiyum Governorate, 63514, Egypt

Location contact

Mohamed A Hamed, MD

CONTACT

[email protected]

1010509736 ext. +20

Mohamed A Hamed, MD

PRINCIPAL_INVESTIGATOR

Mohamed H Ragab, MD

CONTACT

[email protected]

1090050298 ext. +20

Mohamed H Ragab, MD

SUB_INVESTIGATOR

Mohammed R Gomaa, Bch

SUB_INVESTIGATOR

Omar S Farghaly, MD

SUB_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologists (ASA) physical status I or II.
  • Scheduled for elective laparoscopic cholecystectomy under general anesthesia.

Exclusion criteria

  • • 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.
  • 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

Treatment and study plan

EXORA block 15

Procedure

15 mL of bupivacaine 0.25% administered bilaterally by ultrasound guided EXORA block

EXORA block 25

Procedure

25 mL of bupivacaine 0.25% administered bilaterally by ultrasound guided EXORA block

Primary outcomes

  1. 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

Secondary outcomes

  1. Static Numerical Rating scale NRS scores

    Time frame: up to 24 hours post operatively

    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

  2. Dynamic numerical rating scale NRS scores

    Time frame: up to 24 hours post operatively

    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

  3. Cumulative Static Pain Burden

    Time frame: Up to 24h postoperatively

    calculated as the Area Under the Curve (AUC) of Static NRS scores over the 24-hour postoperative period

  4. Cumulative Dynamic Pain Burden

    Time frame: Up to 24h postoperatively

    calculated as the Area Under the Curve (AUC) of Dynamic NRS scores over the 24-hour postoperative period

  5. 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 fentanyl in micrograms

  6. Total cumulative consumption of intravenous morphine over the first 24 hours.

    Time frame: At 24 hours postoperatively

    total morphine used in milligrams post operatively over 24 hours.

  7. Time to first rescue analgesia

    Time frame: Upon recovery from General anesthesia up to 24 hours postoperatively]

    Time to first request of rescue analgesia in hours

  8. Sensory block distribution level (pin-prick test)

    Time frame: At 30 minuets from the block

    After 30 minutes of the block, assessed at. Midclavicular and Midaxillary lines from T5 to T12 level by a blinded anesthesiologist

  9. Quality of recovery score (QoR-15) at 24 hours.

    Time frame: At 24 hours postoperatively

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

  10. Incidence of adverse events: bradycardia, hypotension, PONV, and LAST.

    Time frame: From induction of anesthesia up to 24 hours postoperatively

    Assessment of each patient looking for any of adverse effects as bradycardia ,hypotension, nausea, vomiting and LAST.

  11. Heart rate

    Time frame: Upon arrival to Operating Room until 24 hours postoperative

    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

  12. Mean arterial pressure

    Time frame: Upon arrival to Operating Room until 24 hours postoperative

    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

  13. Ramsay Sedation Scale (RSS)

    Time frame: up to 24 hours

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed H Ragab, MD

CONTACT

[email protected]

1090050298 Ext. +20 ext. +20

Mohammed R Gomaa, Bch

CONTACT

[email protected]

1097830069 ext. +20

Sponsors and collaborators

Lead sponsor

Fayoum University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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