Spinal morphine in patients with hip fractures to reduce delirium

Phase 1

• Conditions: Proximal femur fracture; MedDRA version: 20.0Level: HLGTClassification code 10017322Term: FracturesSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

• Registration Number: EUCTR2020-002143-27-NL
• Lead Sponsor: Maasstad Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-29
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 364

Inclusion Criteria

Scheduled for surgical treatment of a proximal femur fracture
Planned spinal anesthesia.
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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 214

Exclusion Criteria

Contraindications for spinal anesthesia:
- Coagulation disorders (clopidogrel, INR>1.8, anticoagulation with nadroparine (>100 aXa-IE/kg) or heparine (APTT> 30 sec)
- Aortic Valve Stenosis of AVA < 1.0 cm2
- Lumbar malformations (local inflammation, lumbar osteosynthesis material, meningocele, tethered cord)
- Inability to retrieve cerebrospinal fluid by lumbar puncture.
Contra-indications for intrathecal morphine:
- Chronic opioid or benzodiazepine use (>1 month daily use).
Other:
- Allergies to amide-type local anesthetics
- Patients’ refusal

Study & Design

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