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

NCT07378189 | Not Yet Recruiting

• 1 other identifier: 1072.6120.146.2025
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain Management

Keywords

Pain; OFA; Opioid Free Anesthesia

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  measurement of total oxycodone consumption in the postoperative period

  up to 48 hours after surgery

Secondary Outcomes (3)

• Pain assessment

  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 pancreatic operation under balanced anesthesia including opioids

Drug: Balanced anesthesia with opioids

Opioid Free Anesthesia (OFA)

EXPERIMENTAL

Patients who willl have pancreatic operation under Opioid Free anesthesia

Other: Opioid Free Anesthesia (OFA)

Interventions

Opioid Free Anesthesia (OFA) OTHER

Patients who will have pancreatic operation under Opioid Free anesthesia

Opioid Free Anesthesia (OFA)

Balanced anesthesia with opioids DRUG

Patients who will hav pancreatic operation under balanced anesthesia including opioids

Balanced anesthesia with opioids

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University

Krakow, Lesser Poland Voivodeship, 30-688, Poland

Location

MeSH Terms

Conditions

Agnosia; Pain

Interventions

Balanced Anesthesia; Analgesics, Opioid

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, General; Anesthesia; Anesthesia and Analgesia; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Central Study Contacts

Michal Cicio, MD

CONTACT

124001800; michal.cicio@uj.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: older asistent

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 30, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 30, 2026

Record last verified: 2025-12

Locations

PL (1)