MORphine Use in the Fascia Iliaca Compartment Block With UltraSound

• Status: Terminated
• Trial end date: 2020-02-18
• Target enrollment: 0
• Participant gender: All

Summary

Appropriate management of analgesia for proximal femoral fractures is a common problem in the emergency department (ED). Side effects from morphine usage such as nausea, vomiting, respiratory depression, sedation, and obstipation are especially pronounced in elderly. Fascia Iliaca Compartment Block (FICB) holds promise as a simple and safe, and effective alternative method to reduce pain. Local anaesthetic injected in the anatomic space underlying the fascia iliaca, spreads to block the nerves traversing it. This regional anaesthesia includes the femoral nerve. Previous studies in the ED showed promise but lacked blinding, involved low numbers of subjects, or did not use ultrasound localisation of the injection site. The latter is becoming common practice. In this randomised placebo controlled trial the FICB with ultrasound localisation of injection of levobupivacaïne will be compared to the FICB with placebo. It aims to prove that less morphine is used in the intervention group. Other research parameters are pain scores and minor adverse events related to morphine use.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zuyderland Medisch Centrum
• Collaborator: Fresenius Kabi
• Treatments: Acetaminophen; Bupivacaine; Levobupivacaine; Morphine

Criteria

Inclusion Criteria:

• Patient diagnosed with a proximal femoral fracture (femoral neck, trochanteric and sub trochanteric femoral fracture) upon arrival at the ED.

Exclusion Criteria:

1. No informed consent patient

2. Skin infection at injection site(s)

3. Morphine allergy

4. Levobupivacaïne allergy

5. Operation within an hour after admission

6. Inability to understand and quantify pain on a NRS

7. History of dementia

8. Neurological deficit of fractured leg upon arrival at the ED

9. Trauma with multiple fractures (more than 1)

10. Risk of compartment syndrome of ipsilateral lower leg

11. Proximal femoral fracture with other definitive treatment than operation

12. Transfer to another hospital

13. Actual morphine use

14. Distracting pain in other location than hip

15. Pregnancy

16. No physician/nurse available for procedure.

17. BMI > 40

18. Saturation < 90%

19. Previously unreported hypotension (systolic blood pressure < 100 mmHg)

20. ASA IV or higher