Fentanyl nasal spray as a pain reliever after orthopedic surgery

Phase 1

Active, not recruiting

• Conditions: Management of pain following orthopedic surgery; MedDRA version: 21.1Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2018-001630-18-BG
• Lead Sponsor: 5med GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-02
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

[1] Male or female patients =18 years of age
[2] Intended stay in a Post Anesthesia Care Unit (PACU) or recovery room unit for at least 120 minutes after orthopedic surgery performed using general anesthesia for one of the following procedures:
- knee joint endoprosthesis surgery
- isolated fracture of the femur, tibia, fibula, or calcaneus, treated by open reduction and internal fixation (ORIF)
[3] American Society of Anesthesiology (ASA) physical status I, II, or III
[4] Patients who are expected to develop acute moderate or severe pain expected to require parenteral opioids for at least 24 hours after surgery
[5] Patients capable of handling the administration control device
[6] Patients willing and able (e.g. mental and physical condition) to participate in all aspects of the study as evidenced by providing signed written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

[1] History of hypersensitivity or intolerance to the active substance or any of the excipients of the study medication
[2] Patients with respiratory depression, i.e. less than 10 breaths per minute
[3] Patients with clinically significant obstructive airways disease, which is still symptomatic under stable treatment
[4] Patients scheduled for post-operative analgesia supplied by a single-shot or continuous regional technique
[5] Patients scheduled to receive non-steroidal anti-inflammatory drugs (NSAIDs) within 12 hours before surgery, immediately after operation, and during the first 24 hours after start of treatment with study medication
[6] Patients scheduled to received local anesthetics in the surgical area
[7] Patients expected to require another surgical procedure within 48 hours post-operatively
[8] Patients who are expected to receive opioids other than fentanyl or sufentanil intra-operatively or fentanyl postoperatively
[9] Known or suspected opioid tolerance or history of opioid dependence
[10] Chronic treatment with opioids preoperatively on a fixed scheduled (regular) basis within 7 days before surgery
[11] Chronic medication with gabapentine or pregabaline
[12] Patients treated with medication that contains sodium oxybate
[13] Patients with repeated episodes of epistaxis
[14] Previous radiation therapy in the face area
[15] Intake of MAO inhibitors within the last 14 days prior to randomization
[16] Current anatomical abnormalities of the nose that is likely to interfere with the mucosal absorption of fentanyl via the nasal cavities
[17] Severe common cold, intensive hay fever or any other circumstances requiring the use of congestive nasal sprays during the study period
[18] Patient is currently enrolled in, or has completed less than 30 days before the screening examination of the present trial another clinical trial with an investigational drug
[19] Previous enrolment in this study
[20] Pregnant or breast-feeding women
[21] Women of childbearing potential unable or unwilling to use highly effective contraceptive measures until start of hospitalization. Reliable methods for women are:
- combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal);
- progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable);
- intrauterine device (IUD);
- intrauterine hormone-releasing system (IUS);
- bilateral tubal occlusion;
- vasectomized partner;
- sexual abstinence.
[22]Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study
[23]Alcohol/drug dependence or abuse (excluding tobacco abuse)
[24]Unreliability or lack of cooperation
[25]Any other condition of the patient (e.g., serious or unstable medical or psychological condition, acute psychosis) that in the opinion of the investigator may compromise evaluation of the study treatment or may jeopardize patient’s safety, compliance or adherence to protocol requirements.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified