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Delirium in Elderly Patients With Trauma of the Hip (DEPTHip)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02689024
Recruitment Status : Recruiting
First Posted : February 23, 2016
Last Update Posted : March 27, 2019
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Milan Ridderikhof, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Hip Fractures Anesthesia Drug: Bupivacaine Drug: Acetaminophen Drug: Diclofenac Drug: Ibuprofen Drug: Naproxen Drug: Dipyrone Drug: Fentanyl Drug: Morphine Drug: Levobupivacaine Drug: Ropivacaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : May 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Continuous FICB with local anesthetics

With ultrasound guidance, a Fascia Iliaca Compartment Block will be administered and a catheter left in the compartment underneath the iliac fascia. This catheter will remain in place until two days after surgery.

Initial pain treatment in the Emergency Department will be with 40 mL bupivacaine 0.25% or equipotent dosages of levobupivacaine or ropivacaine. Thereafter, until removal of the catheter, pain is treated by titrating local anesthetics according to pain scores.

Drug: Bupivacaine
Local anesthetic: amide group ATC code N01BB01
Other Name: Marcaine

Drug: Levobupivacaine
Local anesthetic: amide group ATC code N01BB10
Other Name: Chirocaine

Drug: Ropivacaine
Local anesthetic: amide group ATC code N01BB09
Other Name: Naropin

Active Comparator: Traditional care with systemic analgesia

Traditional care (usual care) will be on the discretion of the treating physician or hospital protocols and will comprise of systemic opioids such as fentanyl or morphine.

Usually, these opioids are combined with several other drugs, such as: paracetamol, NSAIDs (diclofenac or ibuprofen or naproxen) or dipyrone. (Inter)national guidelines advice morphine as first line agent in elderly patients with hip fractures, as longer acting analgesics are usually required.

Drug: Acetaminophen
Analgesic drug: Acetanilide derivate with analgetic and antipyretic properties ATC code N02BE01
Other Name: Paracetamol

Drug: 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.

Drug: 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.

Drug: 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.

Drug: 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
Other Name: Metamizole, Novalgin

Drug: 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.

Drug: 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.




Primary Outcome Measures :
  1. occurrence of delirium [ Time Frame: three months ]
    Diagnosis will be based on DSM-IV criteria. During hospital admission screening is actively. After discharge, information is gathered by contacting patients and family members, general practitioners or nursing facilities


Secondary Outcome Measures :
  1. duration of delirium [ Time Frame: three months ]
    duration is defined as the total number of days with delirium.

  2. severity of delirium [ Time Frame: three months ]
    severity is defined as percentage of patients with delirium duration > 2 days.

  3. pain [ Time Frame: from hospital admission until 48 hours after surgery ]
    NRS pain scores during complete hospital stay, NRS pain scores will be recorded in the Emergency Department before the intervention as well as after the intervention at 30-minutes time intervals (this is according standard protocol in case opioids are administered). During hospital stay, during each nursing shift, a minimum of one NRS pain score is documented.

  4. need for additional analgesia [ Time Frame: hospital admission until 48 hours after surgery ]
    need for rescue analgesia will be documented during complete Emergency Department and hospital stay.

  5. satisfaction [ Time Frame: from hospital admission until 48 hours after surgery ]
    satisfaction of patients and health care staff regarding efficacy of pain treatment and method of pain treatment is recorded in the Emergency Department and daily during hospital admission (5-point Likert scales and reference questions).

  6. length of hospital stay [ Time Frame: from hospital admission until discharge; an average of 9 days ]
    defined as total consecutive days admitted in the hospital.

  7. ICU admission [ Time Frame: from hospital admission until discharge; an average of 9 days ]
    binary endpoint, whether patient is admitted to the ICU at any moment during hospital stay.

  8. ICU length of stay [ Time Frame: from hospital admission until discharge; an average of 9 days ]
    defined as total days admitted to the ICU department.

  9. hospital re-admission rate [ Time Frame: three months ]
    a re-admission occurs when a patient is admitted to the hospital within three months after initial discharge (from hip fracture related admission).

  10. medical complications [ Time Frame: three months ]
    all events regarding infections, renal- or pulmonary function and cardiovascular events will be accounted for.

  11. surgical complications [ Time Frame: three months ]
    defined as dislocations and fractures.

  12. mortality [ Time Frame: three months ]
    all cause in-hospital-mortality and mortality after hospital discharge.

  13. activities of daily living [ Time Frame: three months ]
    15-item modified Katz Index of Activities of Daily Living at three months after discharge. Baseline will be 2 weeks before presentation.

  14. generic quality of life [ Time Frame: three months ]
    generic HRQol (Euroqol - EQ-5D-5L) at three months after discharge. Baseline will be 2 weeks before presentation.

  15. Oxford hip score [ Time Frame: three months ]
    Oxford Hip Score after 3 months.

  16. cognitive function with Mini Mental State Examination [ Time Frame: three months ]
    Mini Mental State Examination at inclusion in the study, at hospital discharge and at three months after discharge.

  17. cost effectiveness analysis [ Time Frame: three months ]
    primary focus on direct medical costs, direct non-medical costs, indirect costs and productivity loss.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02689024


Contacts
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Contact: Milan Ridderikhof, MD, PhD 0031-(0)20-5660973 m.l.ridderikhof@amc.uva.nl
Contact: Daisy Kolk, MSc 0031-(0)20-5669111 d.kolk@amc.uva.nl

Locations
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Netherlands
Tergooi Ziekenhuis Not yet recruiting
Hilversum, Noord Holland, Netherlands, 1201 DA
Contact: Ton Vervest, MD    0031 88 7531753    avervest@tergooi.nl   
Contact: Jelle Post, MD    0031 88 7531753    jpost@tergooi.nl   
Meander Medical Center Recruiting
Amersfoort, Netherlands, 3813 TZ
Contact: Maurice Pouw, MD    033 850 5050    me.pouw@meandermc.nl   
Slotervaart Medical Center Terminated
Amsterdam, Netherlands, 1066 EC
VU Medical Center Recruiting
Amsterdam, Netherlands, 1081 HV
Contact: Edwin Vandewalle, MD    0031(0)20-4444444    e.vandewalle@vumc.nl   
Academic Medical Center Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: Milan Ridderikhof, MD, PhD    0031-(0)20-5660973    m.l.ridderikhof@amc.uva.nl   
Contact: Daisy Kolk, MSc    0031-(0)20-5663336    d.kolk@amc.uva.nl   
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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Principal Investigator: Markus Hollmann, MD, PhD, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Additional Information:
Publications:

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Responsible Party: Milan Ridderikhof, Emergency Physician and PhD Candidate, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02689024    
Other Study ID Numbers: NL54580.018.15
2015-003650-40 ( EudraCT Number )
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After an embargo period data can be shared, depending on research question, objectives, statistics and methodology.
Keywords provided by Milan Ridderikhof, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Nerve block
Analgesia
Additional relevant MeSH terms:
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Delirium
Hip Fractures
Fractures, Bone
Wounds and Injuries
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Femoral Fractures
Hip Injuries
Leg Injuries
Acetaminophen
Dipyrone
Ibuprofen
Diclofenac
Naproxen
Fentanyl
Analgesics, Opioid
Morphine
Bupivacaine
Ropivacaine
Anesthetics, Local
Levobupivacaine
Anesthetics
Analgesics
Central Nervous System Depressants
Physiological Effects of Drugs