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

Medical University of Graz

Status and phase: Completed; Phase 3

Conditions: Hip Fractures (ICD-10 72.01-72.2)

Treatments: Drug: Fentanyl Transdermal System; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04026022

2gas

Details and patient eligibility

About

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.

Full description

Aim of the study is to evaluate whether the integration of the 2017 ESA guidelines for treatment of postoperative Delirium in a pain management, can improve patient's wellbeing in comparison to the current certified standard management. Adherence to the modified management includes minimizing nil per os time, renouncing benzodiazepines, 1.8 ltr crystalloid infusion per day, simplified standard medication option and postoperative 12µg/h Fentanyl TTS for 72h (for wound pain).

Enrollment: 145 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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145 participants in 2 patient groups, including a placebo group

Standard pain management

Placebo Comparator group

Description:

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)

Treatment:

Drug: Placebo

Modified pain management

Experimental group

Description:

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

Treatment:

Drug: Fentanyl Transdermal System