Postoperative pain relieve for patients undergoing surgical treatment of femoral fracture

Phase 1

• Conditions: Postoperative pain relieve; MedDRA version: 21.1Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2021-002765-17-CZ
• Lead Sponsor: Fakultní nemocnice Ostrava

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-28
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. signed informed consent
2. male and female
3. 60 to 90 years of age
4. surgical treatment of proximal femure fracture
5. ASA classification I to III
6. spinal anaesthesia used for the operation

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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1. general anaesthesia used for the operation
2. allergy for the opioids
3. high risk of respiratory depression

Study & Design

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