Opioid-free Anesthesia as an Alternative to General Anesthesia in Patients Undergoing Laparoscopic Peripheral Pancreatic Resection (OFAPP)

Opioid-free anesthesia is not associated with greater pain than opioid anesthesia and is associated with reduced postoperative pain.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain Management
• Intervention / Treatment: Drug: Balanced anesthesia with opioids; Other: Opioid Free Anesthesia (OFA)

Detailed Description

In our study, the investigators would like to compare the measurement of total oxycodone consumption in the postoperative period in both groups and whether the use of opioid-free anesthesia would reduce opioid consumption by 30%. The secondary objective will be to assess pain in both groups during the first 48 postoperative hours in patients undergoing pancreatic surgery. Patients would be randomly assigned to anesthesia with and without opioids at 1, 2, 6, 12, 24, and 48 hours after surgery. Other secondary objectives include assessing the incidence of postoperative nausea and vomiting (PONV), adverse drug reactions, particularly cardiac arrhythmias, and the impact on persistent postoperative pain. On day 7 after surgery, each patient will receive the QOR-15 questionnaire to assess quality of life and the PQA-10 questionnaire.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michal Cicio, MD; Phone Number: +48 124001800; Email: michal.cicio@uj.edu.pl

Study Locations

• Poland
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-688
      • Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University
      • Contact: Tomasz Skladzien, phd md; Phone Number: +48 12 400 1800; Email: tomasz.skladzien@uj.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient consent to participate in the study
• Qualified for laparoscopic peripheral pancreatic resection
• Age 18-80 years
• ASA II and III

Exclusion Criteria:

• Patient refusal to participate in the study
• Inability to operate a PCA pump
• Lack of understanding of the NRS scale
• Hypersensitivity to anesthetics
• First- or second-degree heart block.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Balanced anesthesia with opioids; Patients who will have pancreatic operation under balanced anesthesia including opioids	Drug: Balanced anesthesia with opioids; Patients who will hav pancreatic operation under balanced anesthesia including opioids
Experimental: Opioid Free Anesthesia (OFA); Patients who willl have pancreatic operation under Opioid Free anesthesia	Other: Opioid Free Anesthesia (OFA); Patients who will have pancreatic operation under Opioid Free anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption	measurement of total oxycodone consumption in the postoperative period	up to 48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment	Assessment of pain at 1, 2, 6, 12, 24, and 48 hours after surgery by NRS scale (0-10, 0 - no pain, 10 worst pain imaginable)	at 1, 2, 6, 12, 24, and 48 hours after surgery
PONV	assessment of the occurrence of postoperative nausea and vomiting (PONV)	up to 48 h after surgery
Quality Of Recovery	QOR-15 questionnaire to assess quality of life and PQA-10 questionnaire. The QOR-15 is a 15 items questionnaire which provides a valid and efficient evaluation of the postoperative quality of recovery. The QoR 15 score is a score of 15 items, each scored from 0 to 10. These items assess 5 dimensions of post-operative recovery: pain, physical comfort, functional autonomy, emotions and psychological support. These 15 items represent the quality of post-operative rehabilitation in its physical and mental dimensions	on the 7th day after surgery

Collaborators and Investigators

• Sponsor: Jagiellonian University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 25, 2025
• First Submitted That Met QC Criteria: January 28, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Opioid Free Anesthesia; OFA
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Agnosia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Narcotics; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Anesthesia and Analgesia; Central Nervous System Agents; Anesthesia; Anesthesia, General; Analgesics, Opioid; Balanced Anesthesia
• Other Study ID Numbers: 1072.6120.146.2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: ndividual participant data (IPD) will be shared contingent upon obtaining appropriate consent from the study participants. Data will be made available only in accordance with applicable ethical and regulatory requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No