Elective Laparoscopic Cholecystectomy, Opioid-Free Anesthesia
Conditions
Keywords
opa
Brief summary
1. To evaluate the efficacy of a standardized multimodal Opioid Sparing (OS) protocol versus conventional opioid-based analgesia in reducing acute postoperative 2. To quantify opioid consumption reduction achievable through OS strategies 3. To assess the impact of OS on hemodynamic parameters during critical surgical phases 4. To compare recovery metrics (PONV, bowel function, ambulation) 5. To evaluate the safety profile of OS anesthesia
Detailed description
The ongoing opioid crisis represents a significant public health challenge, with surgical prescriptions being a major contributor to chronic opioid use and misuse. Recent epidemiological data indicate that 4-6% of opioid- naïve patients develop persistent opioid use postoperatively, with laparoscopic cholecystectomy patients being particularly vulnerable due to moderate postoperative pain . Despite being a minimally invasive procedure, laparoscopic cholecystectomy consistently ranks among the most common general surgical procedures worldwide, with over 1 million performed annually in the United States alone. This frequency amplifies the population-level impact of postoperative prescribing patterns . Previous studies have demonstrated the efficacy of individual components-dexmedetomidine for hemodynamic stabilization, lidocaine infusions for visceral analgesia, and regional techniques like erector spinae plane (ESP) blocks-but their synergistic effects remain underexplored . A recent scoping review highlighted that while opioid-sparing (OS) effects are frequently reported, evidence for clinically meaningful outcomes (e.g., reduced ventilation time, accelerated functional recovery) remains limited . The pathophysiology of post-cholecystectomy pain involves both somatic (abdominal wall) and visceral (diaphragmatic irritation, biliary spasm) components, necessitating a multimodal approach. Opioids inadequately address inflammatory mediators while introducing risks of respiratory depression, postoperative nausea and vomiting (PONV), ileus, and hemodynamic instability. Emerging evidence suggests that α-2 agonists (e.g., dexmedetomidine) and NMDA ant
Interventions
Maintenance Dexmedetomidine 0.2-0.5 µg/kg/h + Lidocaine 1.5 mg/kg/h + Magnesium 10 mg/kg/h; Sevoflurane as required; Atracurium 0.1 mg/kg IV PRN
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Blinding: Participants, anesthetist/ clinicians obserevers and data analysts will be blinded to group allocation.
Intervention model description
Type of the study: Prospective, triple-blind, parallel-group, superiority block randomized controlled trial. Study Setting and design features. • Allocation: Computer-generated 1:1 block randomization with allocation concealment (block size = 6), stratified by ASA status (I vs II/III).
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults aged 18 to 60 years scheduled for elective laparoscopic cholecystectomy. Elective must be included in title. * ASA (American Society of Anesthesiologists) physical status I or II. * Body Mass Index (BMI) \< 35 kg/m².
Exclusion criteria
* Chronic opioid use (\>30 MME/day for \>3 months). * Contraindications to study medications (e.g., severe hepatic impairment; allergy/contraindication to lidocaine, dexmedetomidine, ketamine, fentanyl, or NSAIDs). * Renal dysfunction (eGFR \<60 mL/min/1.73 m²). * Significant cardiac conduction abnormalities. * Pregnancy or lactation. * Emergency surgery or conversion to open cholecystectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity at rest postoperatively (Visual Analog Scale, VAS, 0-10) | 48 hours post operative | Pain intensity at rest will be measured using the Visual Analog Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative opioid use (MME) | 48 hours post operative | Cumulative opioid consumption will be measured in morphine milligram equivalents (MME) administered to each patient. |
| Time to extubating | 24 hours post operative | Time to extubating; time to Aldrete ≥9 |
| Time to first rescue analgesia | 24 hours post operative | time to first demand for rescue analgesia |
| Bowel recovery (first flatus) | 48 hours post operative | Time in hours from completion of surgery until the patient passes first flatus, representing bowel recovery. |
| Ambulation tolerance | 48 hours post operative | Assessment of the patient's ability to ambulate, measured as distance walked in feet or meters within specified postoperative periods. |
Contacts
Primary ContactOla Mahmoud Wahba Gnedy, Assistant Prof.
Backup ContactMohamed Bakr Eid, prof
Outcome results
None listed