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Pain ManagementNCT07364864

Opioid-free Anesthesia as an Alternative to General Anesthesia in Patients Undergoing Duodenopancreatic Surgery by Laparotomy.

A study testing Opioid and OFA in people with Pain Management, run by Jagiellonian University at 1 site in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Opioid-free anesthesia is not associated with greater pain than opioid anesthesia and reduces the need for opioids in the postoperative period. 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 and OFA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 sitePoland
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

  • Age 18-80 years
  • ASA II and III
  • Patient consent to the proposed regional anesthesia
  • Patient consent to participate in the study
  • Surgical procedure in the pancreaticoduodenal area by laparotomy Exclusion criterion
  • Patient refusal to participate in the study
Show all 10Show fewer
  • Inability to operate the PCA pump
  • Lack of understanding of the NRS scale
  • Hypersensitivity to anesthetics
  • First- or second-degree heart block.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tomasz Skladzien, phd md contact

+48 12 4001800 ext. +48

t.skladzien@interia.pl

Poland1 site, 1 recruiting
  • Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University

    Krakow, Lesser Poland Voivodeship, 30688

    Tomasz Skladzien, phd md, +48 12 400 1800, tomasz.skladzien@uj.edu.pl

    Recruiting

Other trials in Poland

About this study

Opioid-free anesthesia is not associated with greater pain than opioid anesthesia and reduces the need for opioids in the postoperative period.

Read the detailed description

Detailed Description General anesthesia using opioids is an accepted, common, and considered safe form of treatment for the patient. Opioids are associated with numerous complications, such as opioid-induced hyperalgesia (the so-called opioid paradox), and postoperative nausea, vomiting, and constipation. Modern anesthesiology, seeking alternatives to opioid-based analgesia, is increasingly turning to low-opioid and opioid-free pain management protocols. By replacing opioids with non-opioid analgesics, co-analgesics, and using regional and local anesthesia techniques, the investigators reduce or avoid the adverse effects of opioids while maintaining a satisfactory level of analgesia for the patient. Methods of administering general anesthesia without or with minimal opioid use have become particularly important in bariatric surgery, reducing the incidence of postoperative respiratory depression and excessive sedation.Opioid-free anesthesia (OFA) is a component of a multimodal, balanced general anesthesia strategy aimed at maximizing the desired analgesic effects while minimizing adverse drug reactions and side effects by utilizing the synergistic effects of various pharmacological agents in combination with regional or local anesthesia techniques. In terms of pharmacology, OFA includes opioid-free anesthesia using non-opioid analgesics - non-steroidal anti-inflammatory drugs, paracetamol, metamizole, and co-analgesics (lidocaine, magnesium, ketamine, dexmedetomidine, gabapentinoids, corticosteroids) and local anesthetics for regional anesthesia.The benefits of ketamine include improved analgesia when combined with opioids or when they are completely eliminated, a reduced incidence of chronic postoperative pain and postoperative nausea and vomiting.The additional use of lidocaine reduces pain intensity in the early postoperative period, as well as the incidence of intestinal atony, nausea and vomiting after abdominal surgery, inhibits the procedure-induced inflammatory response, and reduces the need for opioids. The group of patients to whom the OFA protocol applies includes individuals dependent on opioids, as well as patients with increased tolerance to opioids due to long-term use (pain therapy in cancer, chronic non-cancer pain). Additionally, opioids can influence the infiltration of immune cells in the tumor microenvironment and indirectly exert immunosuppressive effects, thereby participating in an additional mechanism of cancer development and escalation.Due to the increasing number of reports of cancer progression in patients undergoing surgery under general anesthesia using opioids, OFA is believed to have a favorable long-term prognostic effect, especially for oncology patients. The opioid-free protocol is also used for postoperative analgesia. It is estimated that chronic persistent postoperative pain is experienced by up to 75% of surgical patients, which has a particularly negative impact on quality of life.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 who would be anesthetized with opioids and opioid-free anesthesia (patients would be randomly assigned to one group) at 1, 2, 6, 12, 24, and 48 hours after surgery. Other secondary objectives include assessing the occurrence 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, OFA
Keywords
OFA, Opioid consumption, Opioid free anesthesia
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OpioidOther

    Patients who will have duodenopancreatic surgery by laparotomy under balanced anesthesia including opioids

  • OFAOther

    Patients who will have duodenopancreatic surgery by laparotomy under balanced anesthesia including OFA

Study groups in NCT07364864
Study groupRoleWhat they receive
Balanced anesthesia with opioidsActive comparatorPatients who will have duodenopancreatic surgery by laparotomy under balanced anesthesia including opioids
Receives: Other: Opioid
Opioid Free Anesthesia (OFA)ExperimentalPatients who will have duodenopancreatic surgery by laparotomy under balanced anesthesia including OFA
Receives: Other: OFA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Opioid consumption

    oxycodone consumption in the postoperative period

    Measured: up to 48 h after surgery

Secondary outcomes (3)
  1. Pain measurment

    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

  2. PONV

    ponv and vomiting occurence

    Measured: up to 48 h after surgery

  3. 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.

  1. First posted23 Jan 2026
  2. Study start2 Sep 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07364864
Sponsor's protocol ID
1072.6120.145.2025
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: Individual 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.

Questions about this trial

What is this clinical trial studying?

A study testing Opioid and OFA in people with Pain Management, run by Jagiellonian University at 1 site 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 10 inclusion and 0 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 1 site 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 Tomasz Skladzien, phd md (+48 12 4001800 ext. +48, t.skladzien@interia.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 h 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; AzTrials last refreshed its copy on 7 Nov 2026.

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