NCT07364864

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Feb 2026Dec 2027

First Submitted

Initial submission to the registry

December 25, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 23, 2026

Status Verified

December 1, 2025

Enrollment Period

1.9 years

First QC Date

December 25, 2025

Last Update Submit

January 18, 2026

Conditions

Pain Management

Keywords

OFAOpioid consumptionOpioid free anesthesia

Outcome Measures

Primary Outcomes (1)

  • Opioid consumption

    oxycodone consumption in the postoperative period

    up to 48 h after surgery

Secondary Outcomes (3)

  • Pain measurment

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

  • PONV

    up to 48 h after surgery

  • quality of recovery

    on the 7th day after surgery

Study Arms (2)

Balanced anesthesia with opioids

ACTIVE COMPARATOR

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

Other: Opioid

Opioid Free Anesthesia (OFA)

EXPERIMENTAL

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

Other: OFA

Interventions

OpioidOTHER

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

Balanced anesthesia with opioids
OFAOTHER

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

Opioid Free Anesthesia (OFA)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-80 years
  • ASA II and III
  • Patient consent to the proposed regional anesthesia
  • Patient consent to participate in the study
  • Patient refusal to participate in the study
  • Inability to operate the PCA pump
  • Lack of understanding of the NRS scale
  • Hypersensitivity to anesthetics
  • First- or second-degree heart block.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University

Krakow, Lesser Poland Voivodeship, 30688, Poland

Location

MeSH Terms

Conditions

Agnosia

Interventions

Analgesics, Opioid

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NarcoticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnalgesicsSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Central Study Contacts

Tomasz Skladzien, phd md

CONTACT

+48 12 4001800t.skladzien@interia.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

December 25, 2025

First Posted

January 23, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

January 23, 2026

Record last verified: 2025-12

Locations

PL(1)