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Opioid-free Anesthesia as an Alternative to General Anesthesia in Patients Undergoing Laparoscopic Peripheral Pancreatic Resection

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 is associated with reduced postoperative pain.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient consent to participate in the study

Qualified for laparoscopic peripheral pancreatic resection

Age 18-80 years

ASA II and III

Disqualifiers

Patient refusal to participate in the study

Inability to operate a PCA pump

Lack of understanding of the NRS scale

Hypersensitivity to anesthetics

Trial design

Design model

Parallel

Treatments tested in this trial

  • Opioid Free Anesthesia (OFA)

    Other intervention

    Patients who will have pancreatic operation under Opioid Free anesthesia

  • Balanced anesthesia with opioids

    Drug

    Patients who will hav pancreatic operation under balanced anesthesia including opioids

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

measurement of total oxycodone consumption in the postoperative period

Time frame
up to 48 hours after surgery

Secondary outcomes

1

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)

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

PONV

assessment of the occurrence of postoperative nausea and vomiting (PONV)

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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