LAPOFAR Trial: Opioid-Free vs. Remifentanil Anesthesia in Laparoscopic Cholecystectomy

NCT07307625 | Completed

• 2 other identifiers: DrLutfiKirdarTRH-ANES-GT-012024/010.99/10/31
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a single-center, prospective, randomized clinical trial designed to compare the effects of opioid-free anesthesia (OFA) with standard opioid-based anesthesia during elective laparoscopic cholecystectomy. The aim was to evaluate the impact of these two anesthetic approaches on postoperative pain, analgesic requirement, hemodynamic stability, postoperative nausea and vomiting (PONV), and recovery quality. A total of 101 patients, aged 18 to 65 years and classified as ASA I-II, undergoing elective laparoscopic cholecystectomy were enrolled and randomized into two groups. The OFA group received intravenous lidocaine and dexmedetomidine, while the standard anesthesia (RA) group received a remifentanil-based protocol. All other anesthetic agents and surgical procedures were standardized across both groups. Intraoperative monitoring included heart rate, systolic and diastolic blood pressure, and end-tidal CO₂, recorded at 5-minute intervals. Postoperative assessments included visual analog scale (VAS) pain scores at multiple time points (10, 20, 30, 60 minutes; 2, 12, and 24 hours), rescue analgesic use, incidence of PONV, and Modified Aldrete Scores at 0, 30, and 60 minutes. The results demonstrated that patients in the OFA group experienced significantly lower VAS pain scores in both early and late postoperative periods. The OFA group also required less rescue analgesia, had lower heart rate and blood pressure readings postoperatively, and showed a reduced incidence of PONV. Additionally, recovery parameters such as shorter time to extubation and higher early Aldrete scores favored the OFA group. These findings suggest that opioid-free anesthesia using lidocaine and dexmedetomidine is a safe and effective alternative to opioid-based anesthesia in laparoscopic cholecystectomy. It provides better postoperative pain control, reduces opioid-related side effects, and improves overall recovery. The study supports the potential for integrating OFA into enhanced recovery protocols and calls for further multicenter trials with larger sample sizes to validate and generalize the results.

Conditions

Postoperative Pain Management; Postoperative Nausea and Vomiting; Laparoscopic Cholecystectomy; Opioid-free Anesthesia; General Anesthesia

Keywords

Dexmedetomidine; Lidocaine; Opioid-Free Anesthesia; Analgesic Requirement; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Score (VAS)

  VAS at multiple time points post-surgery

  0-24 hrs

Secondary Outcomes (5)

• Rescue Analgesic Use

  0-24 hrs

• PONV Incidence

  0-24 hrs

• Hemodynamic Monitoring

  Intraoperative

• Recovery Score (Aldrete)

  0, 30, 60 min post-extubation

• Extubation Time

  Immediately after surgery

Study Arms (2)

Opioid-Free Anesthesia (OFA)

EXPERIMENTAL

Participants in this group received intravenous lidocaine and dexmedetomidine for opioid-free anesthesia. Lidocaine was administered as a 1.5 mg/kg bolus followed by a continuous infusion of 1.5 mg/kg/h. Dexmedetomidine was administered as a 0.5 µg/kg loading dose over 10 minutes, followed by an infusion of 0.5 µg/kg/h. No opioids were used intraoperatively. Standard induction with propofol and muscle relaxation with rocuronium were applied.

Drug: Lidocaine + Dexmedetomidine

Opioid-Based Anesthesia (RA)

ACTIVE COMPARATOR

Participants in this group received standard general anesthesia with remifentanil infusion at 0.1-0.5 µg/kg/min. Anesthesia induction was performed using propofol and rocuronium. All other surgical and anesthetic parameters were standardized to match those of the OFA group.

Drug: Remifentanil

Interventions

Lidocaine + Dexmedetomidine DRUG

Participants received intravenous lidocaine and dexmedetomidine as part of the opioid-free anesthesia protocol. Lidocaine was administered as a 1.5 mg/kg bolus followed by continuous infusion at 1.5 mg/kg/h. Dexmedetomidine was administered as a 0.5 µg/kg loading dose over 10 minutes, followed by continuous infusion at 0.5 µg/kg/h until the end of surgery. No intraoperative opioids were given.

Opioid-Free Anesthesia (OFA)

Remifentanil DRUG

Participants received standard opioid-based anesthesia with continuous intravenous remifentanil infusion at 0.1-0.5 µg/kg/min. Induction and maintenance of anesthesia were standardized with propofol and rocuronium. All other perioperative conditions were matched to the OFA group.

Opioid-Based Anesthesia (RA)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65
• ASA I-II
• Elective laparoscopic cholecystectomy
• Informed consent
• BMI 18-30 kg/m²
• Normal liver and renal function

You may not qualify if:

• Refusal to participate
• Allergy to study drugs
• Chronic opioid use
• Major organ disease
• Pregnancy or lactation
• Open surgery conversion
• Recent participation in another trial

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

SBÜ Kartal Dr. Lütfi Kırdar City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Pain, Postoperative

Interventions

Lidocaine; Dexmedetomidine; Remifentanil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Department of Anesthesiology and Reanimation

Model Details: Participants were randomly assigned to one of two parallel intervention groups. One group received opioid-free anesthesia (lidocaine and dexmedetomidine infusion), while the other received standard opioid-based anesthesia (remifentanil). Each participant remained in their assigned group throughout the procedure and follow-up period. The study used a 1:1 allocation ratio and compared outcomes such as postoperative pain, nausea and vomiting, and recovery parameters.

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: December 15, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)