Traumatologic Acute Pain Management With Fentanyl Transdermal Therapeutic System (TTS)

NCT04026022 | Completed Phase 3 DMC

• 1 other identifier: 2gas
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study is an examination whether a modified perioperative pain management system, that integrates the 2017 European Society of Anaesthesiology (ESA) guidelines for treatment of postoperative Delirium, can improve patient's wellbeing in comparison to the current certified standard management.

Conditions

Hip Fractures (ICD-10 72.01-72.2)

Outcome Measures

Primary Outcomes (1)

• Patient's wellbeing in the awakening room

  Wellbeing assessed with the "Anaesthesiological Questionnaire" (ANP) which is a self-rating method for the assessment of postoperative complaints and patient wellbeing. The rating scales from 0 to 3, with 0="none" and 3="strongly". Higher wellbeing values represent a better outcome.

  1 year

Secondary Outcomes (3)

• Complication rate (delirium, periprosthetic fractures, wound infections etc)

  Through study completion, an average of 10 days

• Efficacy of the pain management in reducing pain

  Through study completion, an average of 10 days

• Interview assessed identification of selfreported parameters influencing patient-wellbeing

  Through study completion, an average of 72 hours postoperatively

Study Arms (2)

Standard pain management

PLACEBO COMPARATOR

Besides the standard pain management a placebo TTS (normal wound plaster) will be administered in the Emergency Room (ER) or Post Anaesthesia Care Unit (PACU)

Drug: Placebo

Modified pain management

EXPERIMENTAL

Patients will be treated perioperatively with a new pain management, that has been modified to integrate the 2017 ESA guidelines on prevention/treatment of postoperative delirium. Moreover patients will be administered a 12µg/h Fentanyl TTS in the ER or PACU. The ER TTS will only be administered if the patients still has mild to intense pain after initial i.v. treatment as well as reposition of the fractured hip. Further aspects of the modified management are: avoiding benzodiazepines, allowing oral fluids up to 2 hours before surgery, intraoperative monitoring of anaesthesia depth and at least 1,8 ltr crystalloid infusion per day

Drug: Fentanyl Transdermal System

Interventions

Fentanyl Transdermal System DRUG

Patients will be treated perioperatively with a new pain management, that has been modified to integrate the 2017 ESA guidelines on prevention/treatment of postoperative delirium. Moreover patients will be administered a 12µg/h Fentanyl TTS in the ER or PACU. The ER TTS will only be administered if the patients still has mild to intense pain after initial intravenous (i.v.) treatment as well as reposition of the fractured hip. Further aspects of the modified management are: avoiding benzodiazepines, allowing oral fluids up to 2 hours before surgery, intraoperative monitoring of anaesthesia depth and at least 1,8 ltr crystalloid infusion per day.

Modified pain management

Placebo DRUG

Placebo plaster in the ER or PACU

Standard pain management

Eligibility Criteria

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

You may qualify if:

• adult patients with hip fractures that have to be operated (ICD S72.01-S72.2)

You may not qualify if:

• severe liver damage
• ongoing dialysis therapy
• Monoamine oxidase inhibitor intake
• inability to give consent to trial participation

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University Hospital LKH Graz

Graz, 8036, Austria

Location

Related Publications (1)

• Labmayr V, Rief M, Reinbacher P, Gebauer D, Smigaj J, Sandner-Kiesling A, Papamargaritis V, Michaeli K, Bornemann-Cimenti H, Schittek GA. Simplified Pain Management Including Fentanyl TTS in PACU Patients With Hip Fracture Surgery to Improve Patients' Well-Being: A Double-Blind Randomized Trial. J Perianesth Nurs. 2024 Jun;39(3):461-467. doi: 10.1016/j.jopan.2023.10.004. Epub 2023 Dec 11.

  PMID: 38085188 DERIVED

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 19, 2019
• Study Start: June 30, 2019
• Primary Completion: March 6, 2020
• Study Completion: March 6, 2020
• Last Updated: July 22, 2020

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

AU (1)