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

Jagiellonian University

Status: Not yet enrolling

Conditions: Pain Management

Treatments: Other: Opioid Free Anesthesia (OFA); Drug: Balanced anesthesia with opioids

Study type: Interventional

Funder types: Other

Identifiers

NCT07378189

1072.6120.146.2025

Details and patient eligibility

About

Opioid-free anesthesia is not associated with greater pain than opioid anesthesia and is associated with reduced postoperative pain.

Full description

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. Patients would be randomly assigned to anesthesia with and without opioids at 1, 2, 6, 12, 24, and 48 hours after surgery. Other secondary objectives include assessing the incidence 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient consent to participate in the study
• Qualified for laparoscopic peripheral pancreatic resection
• Age 18-80 years
• ASA II and III

Exclusion criteria

• Patient refusal to participate in the study
• Inability to operate a PCA pump
• Lack of understanding of the NRS scale
• Hypersensitivity to anesthetics
• First- or second-degree heart block.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Balanced anesthesia with opioids

Active Comparator group

Description:

Patients who will have pancreatic operation under balanced anesthesia including opioids

Treatment:

Drug: Balanced anesthesia with opioids

Opioid Free Anesthesia (OFA)

Experimental group

Description:

Patients who willl have pancreatic operation under Opioid Free anesthesia

Treatment:

Other: Opioid Free Anesthesia (OFA)