Delirium in Elderly Patients With Trauma of the Hip

NCT02689024 | Terminated Phase 4 DMC

• 2 other identifiers: NL54580.018.152015-003650-40
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 5

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.

Conditions

Hip Fractures; Anesthesia

Keywords

Nerve block; Analgesia

Outcome Measures

Primary Outcomes (1)

• occurrence of delirium

  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

  three months

Secondary Outcomes (17)

• duration of delirium

  three months

• severity of delirium

  three months

• NRS pain scores

  from hospital admission until 48 hours after surgery

• need for additional analgesia

  hospital admission until 48 hours after surgery

• patient satisfaction

  from hospital admission until 48 hours after surgery

Study Arms (2)

Continuous FICB with local anesthetics

EXPERIMENTAL

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; Drug: Levobupivacaine; Drug: Ropivacaine

Traditional care with systemic analgesia

ACTIVE COMPARATOR

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; Drug: Diclofenac; Drug: Ibuprofen; Drug: Naproxen; Drug: Dipyrone; Drug: Fentanyl; Drug: Morphine

Interventions

Bupivacaine DRUG

Local anesthetic: amide group ATC code N01BB01

Also known as: Marcaine

Continuous FICB with local anesthetics

Acetaminophen DRUG

Analgesic drug: Acetanilide derivate with analgetic and antipyretic properties ATC code N02BE01

Also known as: Paracetamol

Traditional care with systemic analgesia

Diclofenac DRUG

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.

Traditional care with systemic analgesia

Ibuprofen DRUG

Non-Steroidal Anti-Inflammatory Drug: Propionic acid derivative ATC code M01AE01 Usual dosage is 400 mg t.i.d. or q.i.d. orally.

Traditional care with systemic analgesia

Naproxen DRUG

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.

Traditional care with systemic analgesia

Dipyrone DRUG

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

Also known as: Metamizole, Novalgin

Traditional care with systemic analgesia

Fentanyl DRUG

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.

Traditional care with systemic analgesia

Morphine DRUG

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.

Traditional care with systemic analgesia

Levobupivacaine DRUG

Local anesthetic: amide group ATC code N01BB10

Also known as: Chirocaine

Continuous FICB with local anesthetics

Ropivacaine DRUG

Local anesthetic: amide group ATC code N01BB09

Also known as: Naropin

Continuous FICB with local anesthetics

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients aged ≥ 55 years with
• a radiographically confirmed hip fracture

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (5)

Tergooi Ziekenhuis

Hilversum, North Holland, 1201 DA, Netherlands

Location

Meander Medical Center

Amersfoort, 3813 TZ, Netherlands

Location

Slotervaart Medical Center

Amsterdam, 1066 EC, Netherlands

Location

VU Medical Center

Amsterdam, 1081 HV, Netherlands

Location

Academic Medical Center

Amsterdam, 1105 AZ, Netherlands

Location

Related Publications (23)

• Abou-Setta AM, Beaupre LA, Rashiq S, Dryden DM, Hamm MP, Sadowski CA, Menon MR, Majumdar SR, Wilson DM, Karkhaneh M, Mousavi SS, Wong K, Tjosvold L, Jones CA. Comparative effectiveness of pain management interventions for hip fracture: a systematic review. Ann Intern Med. 2011 Aug 16;155(4):234-45. doi: 10.7326/0003-4819-155-4-201108160-00346.

  PMID: 21844549 BACKGROUND

• Bruce AJ, Ritchie CW, Blizard R, Lai R, Raven P. The incidence of delirium associated with orthopedic surgery: a meta-analytic review. Int Psychogeriatr. 2007 Apr;19(2):197-214. doi: 10.1017/S104161020600425X. Epub 2006 Sep 14.

  PMID: 16973101 BACKGROUND

• Morrison RS, Magaziner J, Gilbert M, Koval KJ, McLaughlin MA, Orosz G, Strauss E, Siu AL. Relationship between pain and opioid analgesics on the development of delirium following hip fracture. J Gerontol A Biol Sci Med Sci. 2003 Jan;58(1):76-81. doi: 10.1093/gerona/58.1.m76.

  PMID: 12560416 BACKGROUND

• McCusker J, Cole MG, Dendukuri N, Belzile E. Does delirium increase hospital stay? J Am Geriatr Soc. 2003 Nov;51(11):1539-46. doi: 10.1046/j.1532-5415.2003.51509.x.

  PMID: 14687382 BACKGROUND

• Inouye SK, Rushing JT, Foreman MD, Palmer RM, Pompei P. Does delirium contribute to poor hospital outcomes? A three-site epidemiologic study. J Gen Intern Med. 1998 Apr;13(4):234-42. doi: 10.1046/j.1525-1497.1998.00073.x.

  PMID: 9565386 BACKGROUND

• Krogseth M, Wyller TB, Engedal K, Juliebo V. Delirium is a risk factor for institutionalization and functional decline in older hip fracture patients. J Psychosom Res. 2014 Jan;76(1):68-74. doi: 10.1016/j.jpsychores.2013.10.006. Epub 2013 Oct 16.

  PMID: 24360144 BACKGROUND

• Leslie DL, Zhang Y, Holford TR, Bogardus ST, Leo-Summers LS, Inouye SK. Premature death associated with delirium at 1-year follow-up. Arch Intern Med. 2005 Jul 25;165(14):1657-62. doi: 10.1001/archinte.165.14.1657.

  PMID: 16043686 BACKGROUND

• Witlox J, Eurelings LS, de Jonghe JF, Kalisvaart KJ, Eikelenboom P, van Gool WA. Delirium in elderly patients and the risk of postdischarge mortality, institutionalization, and dementia: a meta-analysis. JAMA. 2010 Jul 28;304(4):443-51. doi: 10.1001/jama.2010.1013.

  PMID: 20664045 BACKGROUND

• Leslie DL, Marcantonio ER, Zhang Y, Leo-Summers L, Inouye SK. One-year health care costs associated with delirium in the elderly population. Arch Intern Med. 2008 Jan 14;168(1):27-32. doi: 10.1001/archinternmed.2007.4.

  PMID: 18195192 BACKGROUND

• Dalens B, Vanneuville G, Tanguy A. Comparison of the fascia iliaca compartment block with the 3-in-1 block in children. Anesth Analg. 1989 Dec;69(6):705-13.

  PMID: 2589650 BACKGROUND

• Lopez S, Gros T, Bernard N, Plasse C, Capdevila X. Fascia iliaca compartment block for femoral bone fractures in prehospital care. Reg Anesth Pain Med. 2003 May-Jun;28(3):203-7. doi: 10.1053/rapm.2003.50134.

  PMID: 12772137 BACKGROUND

• Dochez E, van Geffen GJ, Bruhn J, Hoogerwerf N, van de Pas H, Scheffer G. Prehospital administered fascia iliaca compartment block by emergency medical service nurses, a feasibility study. Scand J Trauma Resusc Emerg Med. 2014 Jun 23;22:38. doi: 10.1186/1757-7241-22-38.

  PMID: 24957807 BACKGROUND

• Godoy Monzon D, Iserson KV, Vazquez JA. Single fascia iliaca compartment block for post-hip fracture pain relief. J Emerg Med. 2007 Apr;32(3):257-62. doi: 10.1016/j.jemermed.2006.08.011. Epub 2007 Feb 8.

  PMID: 17394987 BACKGROUND

• Hogh A, Dremstrup L, Jensen SS, Lindholt J. Fascia iliaca compartment block performed by junior registrars as a supplement to pre-operative analgesia for patients with hip fracture. Strategies Trauma Limb Reconstr. 2008 Sep;3(2):65-70. doi: 10.1007/s11751-008-0037-9. Epub 2008 Sep 2.

  PMID: 18762870 BACKGROUND

• Haines L, Dickman E, Ayvazyan S, Pearl M, Wu S, Rosenblum D, Likourezos A. Ultrasound-guided fascia iliaca compartment block for hip fractures in the emergency department. J Emerg Med. 2012 Oct;43(4):692-7. doi: 10.1016/j.jemermed.2012.01.050. Epub 2012 Apr 9.

  PMID: 22494596 BACKGROUND

• Lees D, Harrison WD, Ankers T, A'Court J, Marriott A, Shipsey D, Chaplin A, Reed MR. Fascia iliaca compartment block for hip fractures: experience of integrating a new protocol across two hospital sites. Eur J Emerg Med. 2016 Feb;23(1):12-8. doi: 10.1097/MEJ.0000000000000167.

  PMID: 24949565 BACKGROUND

• Hanna L, Gulati A, Graham A. The role of fascia iliaca blocks in hip fractures: a prospective case-control study and feasibility assessment of a junior-doctor-delivered service. ISRN Orthop. 2014 Mar 4;2014:191306. doi: 10.1155/2014/191306. eCollection 2014.

  PMID: 24977087 BACKGROUND

• Mouzopoulos G, Vasiliadis G, Lasanianos N, Nikolaras G, Morakis E, Kaminaris M. Fascia iliaca block prophylaxis for hip fracture patients at risk for delirium: a randomized placebo-controlled study. J Orthop Traumatol. 2009 Sep;10(3):127-33. doi: 10.1007/s10195-009-0062-6. Epub 2009 Aug 19.

  PMID: 19690943 BACKGROUND

• Adunsky A, Levy R, Heim M, Mizrahi E, Arad M. Meperidine analgesia and delirium in aged hip fracture patients. Arch Gerontol Geriatr. 2002 Nov-Dec;35(3):253-9. doi: 10.1016/s0167-4943(02)00045-6.

  PMID: 14764364 BACKGROUND

• Candal-Couto JJ, McVie JL, Haslam N, Innes AR, Rushmer J. Pre-operative analgesia for patients with femoral neck fractures using a modified fascia iliaca block technique. Injury. 2005 Apr;36(4):505-10. doi: 10.1016/j.injury.2004.10.015.

  PMID: 15755432 BACKGROUND

• Dulaney-Cripe E, Hadaway S, Bauman R, Trame C, Smith C, Sillaman B, Laughlin R. A continuous infusion fascia iliaca compartment block in hip fracture patients: a pilot study. J Clin Med Res. 2012 Feb;4(1):45-8. doi: 10.4021/jocmr724w. Epub 2012 Jan 17.

  PMID: 22383926 BACKGROUND

• Cole MG. Delirium in elderly patients. Am J Geriatr Psychiatry. 2004 Jan-Feb;12(1):7-21.

  PMID: 14729554 BACKGROUND

• Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.

  PMID: 33238043 DERIVED

Related Links

• European Union Clinical Trials Register

MeSH Terms

Conditions

Hip Fractures; Agnosia

Interventions

Bupivacaine; Acetaminophen; Diclofenac; Ibuprofen; Naproxen; Dipyrone; Fentanyl; Morphine; Levobupivacaine; Ropivacaine

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Phenylpropionates; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes

Study Officials

• Markus Hollmann, MD, PhD, PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: February 23, 2016
• Study Start: May 1, 2016
• Primary Completion: July 19, 2023
• Study Completion: July 19, 2023
• Last Updated: August 4, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share

Locations

NL (5)