Medico-economic Evaluation of Sublingual PCA (Zalviso) Versus Oxycodone-PCA in the Management of Postoperative Pain.

NCT03882320 | Completed

• 1 other identifier: PI2018_843_0044
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

More than 230 million surgical operations are been realized all over the world every year. A surgical intervention can cause postoperative acute pain. The management of postoperative acute pain is multimodal and the use of patient-controlled analgesia (PCA) is often a part of this Pain-Management. Intravenous PCA has established itself as a therapeutic concept and constitutes the reference treatment for the management of postoperative acute pain for the first 48 hours. The PCA offers patients autonomy in managing their pain with the intravenous delivery of morphine on demand. Since 2017 PCA Zalviso is marketed. It allows the sublingual administration of sufentanil and it does not require venous access. It seems interesting to allow the early rehabilitation of patients who are no longer limited in their movements by an infusion. However, its acquisition cost appears to be higher than that of the intravenous PCA. In order to verify this hypothesis, the investigators propose to compare the set of costs associated with the use of sublingual PCA with those of intravenous PCA in the management of acute postoperative pain (less than 72 hours) in the context of patients benefiting from the placement of a total knee arthroplasty.

Conditions

Analgesia

Keywords

Sublingual Patient Controlled Analgesia (PCA); Intravenous Patient Controlled Analgesia (PCA); Patient Controlled Analgesia (PCA)

Outcome Measures

Primary Outcomes (1)

• Costs of each Intravenous Patient Controlled Analgesia (PCA)

  Comparison of costs associated with the use of sublingual PCA to those of intravenous PCA

  until 72 hours after knee arthroplasty

Secondary Outcomes (3)

• Length of hospitalization

  until 72 hours after knee arthroplasty

• Efficiency of acute postoperative pain management

  until 72 hours after knee arthroplasty

• Global satisfaction of the patient

  until 72 hours after knee arthroplasty

Study Arms (2)

Sublingual Patient Controlled Analgesia (PCA)

EXPERIMENTAL

Sufentanil Sublingual Patient Controlled Analgesia (PCA)

Procedure: Patient Controlled Analgesia (PCA)

Intravenous Patient Controlled Analgesia (PCA)

ACTIVE COMPARATOR

Oxycodone Intravenous Patient Controlled Analgesia (PCA)

Procedure: Patient Controlled Analgesia (PCA)

Interventions

Patient Controlled Analgesia (PCA) PROCEDURE

Patient Controlled Analgesia (PCA)

Intravenous Patient Controlled Analgesia (PCA); Sublingual Patient Controlled Analgesia (PCA)

Eligibility Criteria

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

You may qualify if:

• adults
• patients able to express consent
• signed written informed consent form
• patient covered by national health insurance
• patient undergoing total knee arthroplasty and requiring postoperative analgesia with the use of a PCA (patient controlled analgesia)

You may not qualify if:

• minors
• obstruction to participate
• patient non covered by national health insurance
• patient requiring a stay in intensive care immediately after the surgery
• patient unable to use a PCA a assessed by the investigator

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• Pitié-Salpêtrière Hospital: collaborator

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

MeSH Terms

Conditions

Agnosia

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Alexandre NTOUBA, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Sandrine THOMAS SORIOT, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Pierre CORIAT, Pr

  Pitié-Salpêtrière Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 20, 2019
• Study Start: March 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)