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

ConditionPain Management
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJagiellonian University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-80 years

ASA II and III

Patient consent to the proposed regional anesthesia

Patient consent to participate in the study

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Opioid

    Other intervention

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

  • OFA

    Other intervention

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Balanced anesthesia with opioidsActive comparator 1 intervention
Group B: Opioid Free Anesthesia (OFA)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Opioid consumption

oxycodone consumption in the postoperative period

Time frame
up to 48 h after surgery

Secondary outcomes

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)

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

PONV

ponv and vomiting occurence

Time frame
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

Time frame
on the 7th day after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jagiellonian University

Lead sponsor

Source ClinicalTrials.gov
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