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

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

Interventions

DRUG

Lidocaine + Dexmedetomidine

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.

DRUG

Remifentanil

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.

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-15

Primary Completion

2025-09-01

Completion

2025-12-01

Countries

• Turkey (Türkiye)

Study Locations