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NCT Number: NCT07378189

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University

Krakow, Lesser Poland Voivodeship, 30-688, Poland

Location contact

Tomasz Skladzien, phd md

CONTACT

[email protected]

+48 12 400 1800

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Opioid Free Anesthesia (OFA)

Other

Patients who will have pancreatic operation under Opioid Free anesthesia

Balanced anesthesia with opioids

Drug

Patients who will hav pancreatic operation under balanced anesthesia including opioids

Primary outcomes

  1. Opioid consumption

    Time frame: up to 48 hours after surgery

    measurement of total oxycodone consumption in the postoperative period

Secondary outcomes

  1. Pain assessment

    Time frame: at 1, 2, 6, 12, 24, and 48 hours after surgery

    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)

  2. PONV

    Time frame: up to 48 h after surgery

    assessment of the occurrence of postoperative nausea and vomiting (PONV)

  3. Quality Of Recovery

    Time frame: on the 7th day after surgery

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Michal Cicio, MD

CONTACT

[email protected]

124001800 ext. +48

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Acronym: OFAPP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 30, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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