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

September 2, 2026 updated by: Tomasz Skladzien, Jagiellonian University
Opioid-free anesthesia is not associated with greater pain than opioid anesthesia and reduces the need for opioids in the postoperative period.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30688
        • Recruiting
        • Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • Inability to operate the PCA pump
  • Lack of understanding of the NRS scale
  • Hypersensitivity to anesthetics
  • First- or second-degree heart block.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Balanced anesthesia with opioids
Patients who will have duodenopancreatic surgery by laparotomy under balanced anesthesia including opioids
Other: Opioid
Patients who will have duodenopancreatic surgery by laparotomy under balanced anesthesia including opioids
Experimental: Opioid Free Anesthesia (OFA)
Patients who will have duodenopancreatic surgery by laparotomy under balanced anesthesia including OFA
Other: OFA
Patients who will have duodenopancreatic surgery by laparotomy under balanced anesthesia including OFA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: up to 48 h after surgery
oxycodone consumption in the postoperative period
up to 48 h after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain measurment
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)
at 1, 2, 6, 12, 24, and 48 hours after surgery
PONV
Time Frame: up to 48 h after surgery
ponv and vomiting occurence
up to 48 h after surgery
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
on the 7th day after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jagiellonian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 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 18, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

September 4, 2026

Last Update Submitted That Met QC Criteria

September 2, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1072.6120.145.2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe