Pain ManagementOFAPPNCT07378189
Opioid-free Anesthesia as an Alternative to General Anesthesia in Patients Undergoing Laparoscopic Peripheral Pancreatic Resection
A study testing Opioid Free Anesthesia (OFA) and Balanced anesthesia with opioids in people with Pain Management, run by Jagiellonian University at 2 sites in Poland.
Trial summary
Opioid-free anesthesia is not associated with greater pain than opioid anesthesia and is associated with reduced postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain Management
- What is being tested?
- Opioid Free Anesthesia (OFA) and Balanced anesthesia with opioids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesPoland
- Study dates
- 2 Sep 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient consent to participate in the study
- Qualified for laparoscopic peripheral pancreatic resection
- Age 18-80 years
- ASA II and III
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Poland2 sites, 2 recruiting
- Recruiting
Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University
Krakow, Lesser Poland Voivodeship, 30-688
Tomasz Skladzien, phd md, +48 12 400 1800, tomasz.skladzien@uj.edu.pl
- Recruiting
University Hospital in Cracow
Krakow, Lesser Poland Voivodeship, 30-688
Tomasz Skladzien, MD PHD, +48124001800, tskladzien@su.krakow.pl
About this study
Opioid-free anesthesia is not associated with greater pain than opioid anesthesia and is associated with reduced postoperative pain.
Read the 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.
- Conditions
- Pain Management
- Being tested
- Opioid Free Anesthesia (OFA), Balanced anesthesia with opioids
- Keywords
- Pain, OFA, Opioid Free Anesthesia
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Free Anesthesia (OFA)Other
Patients who will have pancreatic operation under Opioid Free anesthesia
Balanced anesthesia with opioidsDrug
Patients who will hav pancreatic operation under balanced anesthesia including opioids
| Study group | Role | What they receive |
|---|---|---|
| Balanced anesthesia with opioids | Active comparator | Patients who will have pancreatic operation under balanced anesthesia including opioids Receives: Drug: Balanced anesthesia with opioids |
| Opioid Free Anesthesia (OFA) | Experimental | Patients who willl have pancreatic operation under Opioid Free anesthesia Receives: Other: Opioid Free Anesthesia (OFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
measurement of total oxycodone consumption in the postoperative period
Measured: up to 48 hours after surgery
Secondary outcomes (3)
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)
Measured: at 1, 2, 6, 12, 24, and 48 hours after surgery
PONV
assessment of the occurrence of postoperative nausea and vomiting (PONV)
Measured: 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
Measured: on the 7th day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start2 Sep 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Skladzien, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378189
- Sponsor's protocol ID
- 1072.6120.146.2025
- Acronym
- OFAPP
- Status last verified
- Dec 2025
- First submitted
- 25 Dec 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid-free Anesthesia as an Alternative to General Anesthesia in Patients Undergoing Laparoscopic Peripheral Pancreatic Resection
- ClinicalTrials.gov ID
- NCT07378189
- Acronym / sponsor ID
- OFAPP / 1072.6120.146.2025
- Conditions
- Pain Management
- Keywords
- Pain, OFA, Opioid Free Anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 2 Sep 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Opioid-free anesthesia is not associated with greater pain than opioid anesthesia and is associated with reduced postoperative pain.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balanced anesthesia with opioids | Active comparator | Drug: Balanced anesthesia with opioidsPatients who will have pancreatic operation under balanced anesthesia including opioids |
| Opioid Free Anesthesia (OFA) | Experimental | Other: Opioid Free Anesthesia (OFA)Patients who willl have pancreatic operation under Opioid Free anesthesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient consent to participate in the study
- Qualified for laparoscopic peripheral pancreatic resection
- Age 18-80 years
- ASA II and III
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid Free Anesthesia (OFA)Patients who will have pancreatic operation under Opioid Free anesthesia | Other | Opioid Free Anesthesia (OFA) |
| Balanced anesthesia with opioidsPatients who will hav pancreatic operation under balanced anesthesia including opioids | Drug | Balanced anesthesia with opioids |
Primary outcome
Opioid consumption
Time frame: up to 48 hours after surgery
measurement of total oxycodone consumption in the postoperative period
3 secondary outcomes
Pain assessment
Time frame: at 1, 2, 6, 12, 24, and 48 hours after surgery
PONV
Time frame: up to 48 h after surgery
Quality Of Recovery
Time frame: on the 7th day after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid Free Anesthesia (OFA) and Balanced anesthesia with opioids in people with Pain Management, run by Jagiellonian University at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michal Cicio, MD (124001800 ext. +48, michal.cicio@uj.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption (time frame: up to 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.