Clinical trial NCT03846102: MORphine Use in the Fascia Iliaca Compartment Block With UltraSound
Official title: MORphine Use in the Fascia Iliaca Compartment Block With UltraSound
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Humans
Anesthetics, Local
Morphine
Pain Management
Analgesia
Pain
Anesthesia, Local
Fascia
Emergency Medicine
Analgesia, Patient-Controlled
Ultrasonography
Femoral Fracture
Keywords: Fascia Iliaca Compartment Block
Peripheral Nerve Block
Elderly
Hip fracture
Levobupivacaïne
Morphine
Emergency Physician
Emergency department
Ultrasound
Pain score
Numerical Rating scale
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
Collaborators: name: Fresenius Kabi
First posted: 2019-02-19
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blinded randomized placebo-controlled trial
Primary purpose: TREATMENT

Brief 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.

Detailed description: Proximal femoral fractures are common in the ED. A major challenge in such subjects is pain management. Suboptimal pain control is associated with stress, a prolonged hospital stay and delirium. Pain or fear of pain can limit early mobilisation, an important goal in treatment. Therefore early pain management is essential. Standard analgesic care consists of acetaminophen, opiates and/or Non-steroidal anti-inflammatory drugs (NSAID's). Opiates can cause respiratory depression, constipation, drowsiness, nausea and vomiting. Especially elderly patients are at risk for these side effects Regional nerve blocks are increasingly being adopted as an alternative pain management to systemic analgesia in the ED. One of such is the Fascia Iliaca Compartment Block (FICB). This is safe and simple to perform. Results from studies, despite lacking ultrasound guidance are promising. No permanent disability resulted from the few minor complications that have been reported. These include bladder perforation, pneumoretroperitoneum and neuropathy of the femoral nerve. Furthermore no additional treatment was necessary. Ultrasound prevents occurrence of such complications.

The studies that have compared this specific block to standard analgesia have shown that regional anaesthesia may be superior. However these studies have low inclusion numbers and lack of randomisation and/or blinding.. Literature up until now has used the numerical rating scale (NRS) as a primary outcome. Although the NRS is a very trustworthy method of measuring pain, the score is a subjective outcome Morphine consumption on the other hand is more objective.

The FICB involves the anatomic space situated at the level of the groin in which important nerves that supply the hip joint lie. Anteriorly the space is covered by the iliac fascia. It is therefore known as the fascia iliaca compartment. By introducing a large volume of local anaesthetic solutions, the femoral, lateral femoral cutaneous and to a lesser extent the obturator nerve are anesthetized. Solutions can spread easily within the compartment. Therefore a safe position injection site can be chosen, minimizing the risk of intravascular injection and nerve damage. The classic position for injection is about 3 centimetres lateral from the femoral nerve. In the original FICB the injection site is determined by using landmarks. The fascia iliaca compartment is then approached by introducing a blunt needle, which enables the physician to feel a 'pop' twice. The first pop is felt when the fascia lata is pierced, the second when the fascia iliaca is passed.

Most ED's nowadays have access to ultrasound. When used for FICB placement, the local anaesthetic solution is visualized as it is introduced into the space. Therefore a higher chance of successful placement of agent and a lower risk of complications can be expected. So far no large double blind randomised placebo controlled trials have evaluated morphine use in ultrasound guided placement of local anaesthetic agents with FICB in the ED. This study is designed as such. Total morphine use will be taken as the primary outcome, administered in the form of patient controlled analgesia (PCA).

Eligibility 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

Primary outcomes:
measure: Mean morphine consumption in milligrams per hour with PCA pump, extracted from PCA-pump memory (mg / hour).
timeFrame: From FICB placement up to 6 hours.
Secondary outcomes:
measure: Morphine consumption in milligrams per hour at each hour in the time preceding operation. (mg / hour)
timeFrame: Time from FICB placement until operation, up to 24 hours. Time point: each hour
measure: Average of PCA-pump requests for morphine per hour (presses / hour)
timeFrame: Time from FICB placement until operation, up to 24 hours. Time point: each hour
measure: Average time to first morphine administration with PCA-pump (minutes)
timeFrame: Time from FICB placement until operation, up to 24 hours.
measure: Average pain score at different time points.
timeFrame: Time from FICB placement until operation, up to 24 hours. Time point: each hour
measure: Difference in pain scores at movement.
timeFrame: Time from FICB placement until operation, up to 24 hours. Time point: each hour
measure: Patients with occurence of NRS > 3.
timeFrame: Time from FICB placement until operation, up to 24 hours. Time point at 24 hours.
measure: Number of patients with a delirium in preoperative period.
timeFrame: Time from FICB placement until operation, up to 24 hours. Time point at 24 hours.
measure: The number of patients with morphine related side effects.
timeFrame: This will be assessed by the nurse at the rounds each shift up to 3 times daily until operation or up to 24 hours.
measure: Number of patients with treatment-related adverse events as assessed by CTCAE v4.0.
timeFrame: Time from FICB placement until operation, up to 24 hours.
measure: Time spent on FICB placement in seconds.
timeFrame: The time from needle entering patient, until procedure is terminated by the emergency physician.
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Zuyderland Medisch Centrum
state: Zuid Limburg
Study officials:
affiliation: Zuyderland Medical Center
name: Sanne Postma, MD
role: PRINCIPAL_INVESTIGATOR
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