Pain, Postoperative, Post Operative Analgesia
Conditions
Keywords
EXORA, analgesic efficacy, low volume, laparoscopic cholecystectomy
Brief 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.
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
Interventions
PROCEDUREEXORA block 15
15 mL of bupivacaine 0.25% administered bilaterally by ultrasound guided EXORA block
PROCEDUREEXORA block 25
25 mL of bupivacaine 0.25% administered bilaterally by ultrasound guided EXORA block
Sponsors
Fayoum University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dynamic numerical rating scale (NRS) score at 4 hours postoperatively. | 4 hours after surgery | From 0 to 10 where 0 denote no pain and 10 denote the worst pain ever experienced with cough |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Static Numerical Rating scale NRS scores | 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 |
| Dynamic numerical rating scale NRS scores | 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 |
| Cumulative Static Pain Burden | Up to 24h postoperatively | calculated as the Area Under the Curve (AUC) of Static NRS scores over the 24-hour postoperative period |
| Cumulative Dynamic Pain Burden | Up to 24h postoperatively | calculated as the Area Under the Curve (AUC) of Dynamic NRS scores over the 24-hour postoperative period |
| Intraoperative Fentanyl consumption Total fentanyl in micrograms | From induction of anesthesia until patient is transferred to postoperative care unit up to 4 hours] | Total fentanyl in micrograms |
| Total cumulative consumption of intravenous morphine over the first 24 hours. | At 24 hours postoperatively | total morphine used in milligrams post operatively over 24 hours. |
| Time to first rescue analgesia | Upon recovery from General anesthesia up to 24 hours postoperatively] | Time to first request of rescue analgesia in hours |
| Sensory block distribution level (pin-prick test) | 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 |
| Quality of recovery score (QoR-15) at 24 hours. | At 24 hours postoperatively | scores range from 0 to 150, with a higher score indicating a better quality of postoperative recovery. |
| Incidence of adverse events: bradycardia, hypotension, PONV, and LAST. | 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. |
| Heart rate | 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 |
| Mean arterial pressure | 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 |
| Ramsay Sedation Scale (RSS) | 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) |
Countries
Egypt
Contacts
CONTACTMohammed R Gomaa, Bch
CONTACTMohamed H Ragab, MD
PRINCIPAL_INVESTIGATORMohamed A Hamed,, MD
Faculty of medicine, Fayoum university
Outcome results
None listed