Effect of Opioid-Free Anesthesia (OFA) on Postoperative Pain and Perioperative Nausea and Vomiting in Elective Laparoscopic .

NCT ID: NCT07306910

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-30
• Study Completion Date: 2028-12-30

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

Conditions

Opioid-Free Anesthesia; Elective Laparoscopic Cholecystectomy

Keywords

opa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

OpioidSparingGroup OS)

Group Type: ACTIVE_COMPARATOR

opoid free anesthesia

Intervention Type: OTHER

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

ControlGroup (CG)

Group Type: ACTIVE_COMPARATOR

opoid free anesthesia

Intervention Type: OTHER

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

Interventions

opoid free anesthesia

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

Intervention Type: OTHER

Other Intervention Names

Lidocaine; Dexmedetomidine; Magnesium

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Galal Eldeen Hasan Hasan Hussein

resident at the anesthesia , icu and pain management department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ola Mahmoud Wahba Gnedy, Assistant Prof.

Role: CONTACT

Phone: 01151121981

Email: ola.genadi@med.aun.edu.eg

Mohamed Bakr Eid, prof

Role: CONTACT

Phone: 01223213370

Email: bakr@aun.edu.eg

Related Links

https://doi.org/10.1016/0952-8180(94)00001-K

Aldrete, J. A. (1995). The post-anesthesia recovery score revisited. Journal of Clinical Anesthesia, \*7\*(1), 89-91.

https://grants.nih.gov/grants/guide/notice-files/NOT-DA-22-052.html

.National Institutes of Health. HEAL Initiative: Preventing Opioid Use Disorder After Surgery. NIH Guide NOT-DA-22-052. 2022.

https://doi.org/10.1016/S0140-6736(74)90884-8

. Huskisson, E. C. (1974). Measurement of pain. The Lancet, \*304\*(7889), 1127-1131.

Other Identifiers

211198

Identifier Type: REGISTRY

Identifier Source: secondary_id

211198

Identifier Type: -

Identifier Source: org_study_id