Clinical trial
A Multicenter Randomized Controlled Trial in Elderly Patients With Hip Fractures Comparing Continuous Fascia Iliaca Compartment Block to Systemic Opioids and Its Effect on Delirium Occurrence
Name
NL54580.018.15
Description
A broken hip occurs frequently in elderly patients and is often very painful. Side effects of inadequately treated pain as well as the traditional drugs (administered through intravenous catheter) used to treat pain are, among others, a confusional state, called delirium. When pain medication is administered locally, only around the hip joint, pain might be treated more effectively and these side effects could be prevented. This is called a nerve block.
The current study evaluates the use of a continuous nerve block throughout the complete hospital admission with a catheter around the hip joint versus the use of traditionally used pain medication administered though an intravenous catheter in elderly patients with a broken hip. Half of all patients will receive the nerve block while in the emergency department and the other half will receive pain medication through the intravenous access.
Trial arms
Trial start
2016-05-01
Estimated PCD
2023-07-19
Trial end
2023-07-19
Status
Terminated
Phase
Early phase I
Treatment
Bupivacaine
Local anesthetic: amide group ATC code N01BB01
Arms:
Continuous FICB with local anesthetics
Other names:
Marcaine
Acetaminophen
Analgesic drug: Acetanilide derivate with analgetic and antipyretic properties ATC code N02BE01
Arms:
Traditional care with systemic analgesia
Other names:
Paracetamol
Diclofenac
Non-Steroidal Anti-Inflammatory Drug: Acetic acid derivative ATC code M01AB05 Usual dosage is 50 mg t.i.d. orally or 75 mg b.i.d. intramuscularly. In the Netherlands, intravenous administration is not used.
Arms:
Traditional care with systemic analgesia
Ibuprofen
Non-Steroidal Anti-Inflammatory Drug: Propionic acid derivative ATC code M01AE01 Usual dosage is 400 mg t.i.d. or q.i.d. orally.
Arms:
Traditional care with systemic analgesia
Naproxen
Non-Steroidal Anti-Inflammatory Drug: Propionic acid derivative ATC code M01AE02 Usual dosage is initially 500 mg orally, followed by 250 mg b.i.d. or t.i.d.
Arms:
Traditional care with systemic analgesia
Dipyrone
Analgesic drug: Pyrazolone derivate with analgetic, antipyretic and antiphlogistic properties ATC N02BB02 Usual dosage is 1000 mg t.i.d. or q.i.d. orally and intravenously
Arms:
Traditional care with systemic analgesia
Other names:
Metamizole, Novalgin
Fentanyl
Opioids: Phenylpiperidine derivative. Short-acting opioid. ATC code N02AB03 Usual dosage is 1 ug/kg intravenously and titrated guided by pain scores and possible side effects. Above the age of 60, dosages are usually divided in two in order to prevent adverse events.
Arms:
Traditional care with systemic analgesia
Morphine
Opioids: Natural opium alkaloid. Longer-acting opioid. ATC code N02AA01 Usual dosage is 0.1 mg intravenously and titrated guided by pain and possible side effects. Above the age of 60, dosages are usually divided in two in order to prevent adverse events.
Arms:
Traditional care with systemic analgesia
Levobupivacaine
Local anesthetic: amide group ATC code N01BB10
Arms:
Continuous FICB with local anesthetics
Other names:
Chirocaine
Ropivacaine
Local anesthetic: amide group ATC code N01BB09
Arms:
Continuous FICB with local anesthetics
Other names:
Naropin
Size
239
Primary endpoint
occurrence of delirium
three months
Eligibility criteria
Inclusion Criteria:
* adult patients aged ≥ 55 years with
* a radiographically confirmed hip fracture
Exclusion Criteria:
* multiple injuries (polytrauma patients)
* previous adverse reaction or known allergy to local anaesthetics or opioids or paracetamol
* skin infection in proximity of injection site
* delirious state at presentation in the ED
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 239, 'type': 'ACTUAL'}}
Updated at
2023-08-04
1 organization
9 products
1 drug
2 indications
Product
BupivacaineIndication
Hip FracturesIndication
AnesthesiaProduct
AcetaminophenProduct
DiclofenacProduct
IbuprofenProduct
NaproxenProduct
DipyroneDrug
KetamineProduct
MorphineProduct
LevobupivacaineProduct
Ropivacaine