Delirium in Elderly Patients With Trauma of the Hip

NCT02689024 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2023-08-04

No results posted yet for this study

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

Interventions

DRUG

Bupivacaine

Local anesthetic: amide group ATC code N01BB01

DRUG

Acetaminophen

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

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

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.

DRUG

Levobupivacaine

Local anesthetic: amide group ATC code N01BB10

DRUG

Ropivacaine

Local anesthetic: amide group ATC code N01BB09

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Markus Hollmann, MD, PhD, PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2023-07-19
Completion
2023-07-19

Countries

  • Netherlands

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02689024 on ClinicalTrials.gov