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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
96
15 mL of bupivacaine 0.25% administered bilaterally by ultrasound guided EXORA block
25 mL of bupivacaine 0.25% administered bilaterally by ultrasound guided EXORA block
Fayoum University hospital
El Fayoum Qesm, Faiyum Governorate, Egypt
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
Time frame: 4 hours after surgery
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 24h postoperatively
Intraoperative Fentanyl consumption Total fentanyl in micrograms
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.
total morphine used in milligrams post operatively over 24 hours.
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Time frame: At 24 hours postoperatively
Time to first rescue analgesia
Time to first request of rescue analgesia in hours
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: up to 24 hours