Low Versus Standard Volume EXORA Block in Laparoscopic Cholecystectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFayoum University Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
American Society of Anesthesiologists (ASA) physical status I or II.
Scheduled for elective laparoscopic cholecystectomy under general anesthesia.
Disqualifiers
• 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
Trial design
Design model
Parallel
Treatments tested in this trial
EXORA block 15
Procedure/Surgery15 mL of bupivacaine 0.25% administered bilaterally by ultrasound guided EXORA block
EXORA block 25
Procedure/Surgery25 mL of bupivacaine 0.25% administered bilaterally by ultrasound guided EXORA block
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: EXORA 15Active comparator 1 intervention
Group B: EXORA 25Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 surgerySecondary outcomes
1
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 operatively2
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 operatively3
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 postoperatively4
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 postoperativelySponsors and contacts
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Source ClinicalTrials.gov