Clinical Outcomes of Analgesia Methods in Patients With Hip Fracture

February 21, 2020 updated by: Mustafa Azizoğlu, Mersin University
The goal of this study is to determine of clinical outcomes of analgesia methods. The primary outcomes are opioid consumption, static and dynamic visual analog scale (VAS) scores. Secondary outcomes are occurrence of side effects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Hip fracture is one of the most serious consequences of falls in the elderly, with a mortality of 10% at one month and 30% at one year. Factors of associated with increased morbidity and mortality have been researched to prevent complications.

Pain has been associated with delirium and depression in hip fracture patients. Besides, narcotic drugs are also associated with some side effects such as delirium, postoperative nausea and vomiting (PONV ), cardiovascular and respiratory depression. These clinical problems are especially important in the elderly population.

Fascia iliaca compartment block (FICB) is one of the methods applied for postoperative analgesia, which is applied under the inguinal ligament and distributes between the femoral nerve and lateral femoral cutaneous nerve block by volumetric effect. Recently, studies have been published on hip fracture patients using pop up technique in emergency services. Although many studies have shown that FICB is effective in perioperative analgesia, the effects of this method on complications and mortality rate have not yet been investigated.

The primary objective is to compare morphine consumption and VAS scores in patients with hip fracture who treated with epidural catheter, fascia iliaca compartment catheter or patient controlled analgesia.

The secondary objective is to determine complications. The investigators hypothesize that FICB catheter will provide good pain control same as epidural catheter, and will decrease complications such as delirium and pain with less mortality rate.

Patients with pain in the hip fracture, will be evaluated after admission to the hospital and analgesic treatment will be applied to patients with Visual Analog Pain Scale (VAS) score 3 and above.

Patients will be divided into three groups; Group I will include patients with treated FICB catheter, Group II will include patients with treated patient controlled analgesia, Group III will include patients with treated epidural catheter,

Catheters will be placed with US visualization in Group I. A hyperechoic needle will be used (18 G 80 mm) for inserting catheter in Group I and III.

Group I will receive 30 ml of Bupivacaine 0.25% solution through the fascia iliaca compartment catheter.

Group II will receive, morphine 0.1 mg/ml via patient controlled analgesia pump. every pump will be set 1 mg dose morphine per use and 15 min lockout time.

Group III will receive 10 ml of Bupivacaine 0.25% solution through the epidural catheter.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Mersin, Turkey, 33343
        • Mustafa Azizoğlu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Study will be performed from 01/12/2018 to 01/06/2019. It is estimated to each group includes 40 patient.

Description

Inclusion Criteria:

  • Patients without communication problems (delirium, hearing loss, language problems etc.)
  • Patients who do not use regular analgesic medication for any chronic disease
  • Patients without any neurological deficit at the lower extremity
  • Patients without renal or hepatic dysfunction
  • Patients without bleeding diathesis
  • Patients with isolated femur fractures

Exclusion Criteria:

  • Patients with communication problems
  • Patients who use regular analgesic medication for any chronic disease
  • Patients with neurological deficits in the lower extremity
  • Patients with renal or hepatic dysfunction
  • Patients with bleeding diathesis
  • Patients with multiple trauma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group 1
Group I will receive 30 ml of Bupivacaine 0.25% solution through the fascia iliaca compartment catheter. Catheter will be inserted with US.
Procedure: Fascia iliaca compartment catheter
Patient will evaluate and if VAS score >3, catheter will be inserted and 30 ml bupivacaine 0.25% will be applied after admission. Dose will be repeated VAS>3 or patient enounce pain.
Group 2
Group II will receive, morphine 0.1 mg/ml via patient controlled analgesia pump. every pump will be set 1 mg dose morphine per use and 15 min lockout time.
Procedure: patient controlled analgesia
Patient will evaluate and if VAS score >3, patient controlled analgesia pump will be set 1mg morphine/15 min lockout.
Group 3
Group III will receive 10 ml of Bupivacaine 0.25% solution through the epidural catheter.
Procedure: epidural catheter
Patient will evaluate and if VAS score >3, catheter will be inserted and 10 ml bupivacaine 0.25% will be applied after admission. Dose will be repeated VAS>3 or patient enounce pain.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Morphine consumption
Time Frame: From the beginning of treatment to discharge (Totally 5 days)
All perioperative morphine consumption will be recoreded every 6 hours.
From the beginning of treatment to discharge (Totally 5 days)
Visual analogue score
Time Frame: From admission to second postoperative day. (Totally 5 days)
Mean visual analogue scores will be compared for 3 groups. VAS score will measured from 0 to 10. Higher values represent worse outcome.
From admission to second postoperative day. (Totally 5 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
incidence of postoperative complications in 30 day post-surgery.
Time Frame: From end of surgery to Day 30 after surgery (totally 30 days)
Patients will be monitored and every serious complication related with surgery including respiratory failure, hypotension, delirium, thromboembolism, nausea and vomiting will be recorded. These events will be measured as percentage (%)
From end of surgery to Day 30 after surgery (totally 30 days)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anticoagulant medication status in the S-FICB group
Time Frame: First day (15 min)
The use of anticoagulant drugs will be questioned and recorded in the S-FICB group
First day (15 min)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mersin University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mustafa Azizoglu, Mersin University, Anesthesia and Reanimation Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MEUANEST001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Every entered data could share to other researchers

IPD Sharing Time Frame

After 01/03/2019

IPD Sharing Access Criteria

Sharing access will be depends on requests.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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