Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture (Delirium-Hip)

July 10, 2022 updated by: Dr Kassiani Theodoraki, Aretaieion University Hospital

Correlation Between Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture

The objective of this trial will be to establish whether the ultrasound-guided suprainguinal fascia iliaca compartment block is capable of protecting geriatric patients with hip fracture from delirium as compared to placebo

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Geriatric patients suffer from hip fractures very often. Delirium is a perioperative neuropsychiatric complication that is characterized by sudden change of mental status, inattention, disorientation and memory impairment with fluctuations of symptoms during the day. Delirium causes increased morbidity and mortality, decreased postoperative functional activity and may predispose to dementia.

Perioperative pain may be an important predisposing factor to delirium. Intravenous opioids have been widely used to relieve patients with hip fracture from pain, but they have a lot of complications and have been correlated with delirium as well. Fascia Iliaca compartment block is a peripheral compartment nerve block that is used in hip surgeries. Use of this compartment nerve block to protect geriatric patients from delirium has not been studied.

The objective of this trial will be to establish whether the ultrasound-guided suprainguinal fascia iliaca compartment block is capable of protecting geriatric patients with hip fracture from delirium as compared to placebo

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Greece
      • Kifisiá, Greece, 14561
        • Recruiting
        • KAT General Hospital of Athens
        • Contact:

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

Ages Eligible for Study

75 years to 105 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • geriatric patients
  • American Society of Anesthesiologists (ASA) I-III
  • hip fracture patients

Exclusion Criteria:

  • dementia
  • communication or language barriers
  • patients with nutritional problems
  • bedridden patients

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: fascia iliaca compartment block with ropivacaine
in this arm, the fascia iliaca compartment block will be performed with 40 mL ropivacaine 0.25%
Other: fascia iliaca compartment block with ropivacaine
the fascia iliaca compartment block catheter will be placed with the use of ultrasound till the day of surgery. Bolus doses will be given every 12 hours (40 ml of ropivacaine 0.25%)
Other Names:
  • medication in regional anesthetic technique
Placebo Comparator: fascia iliaca compartment block with placebo
in this arm, the fascia iliaca compartment block will be performed with 40 mL normal saline
Other: fascia iliaca compartment block with placebo
the fascia iliaca compartment block catheter will be placed with the use of ultrasound till the day of surgery. Bolus doses will be given every 12 hours (40 ml of normal saline)
Other Names:
  • medication in regional anesthetic technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score 30 minutes after fascia iliaca block
Time Frame: 30 minutes after performance of fascia iliaca block
pain score by the use of Numeric Rating Scale (NRS) 30 minutes after fascia ilaca block, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
30 minutes after performance of fascia iliaca block
pain score 12 hours after fascia iliaca block
Time Frame: 12 hours after performance of fascia iliaca block
pain score by the use of Numeric Rating Scale (NRS) 12 hours after fascia ilaca block, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
12 hours after performance of fascia iliaca block

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score 1-8 days after fascia iliaca block
Time Frame: 1-8 days after fascia iliaca block
pain score by the use of Numeric Rating Scale (NRS) 1-8 days after fascia ilaca block, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
1-8 days after fascia iliaca block

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini Mental State examination
Time Frame: arrival to the emergency room
Mini Mental State examination on arrival to the emergency room
arrival to the emergency room
Mini Mental State examination
Time Frame: 1-8 days postoperatively
Mini Mental State examination postoperatively
1-8 days postoperatively
Confusion Assessment Method
Time Frame: arrival to the emergency room
Confusion Assessment Method on arrival to the emergency room
arrival to the emergency room
Confusion Assessment Method
Time Frame: 1-8 days postoperatively
Confusion Assessment Method postoperatively
1-8 days postoperatively
requests for analgesia
Time Frame: 1-8 days postoperatively
requests for analgesia postoperatively
1-8 days postoperatively
tramadol consumption
Time Frame: 1-8 days postoperatively
tramadol consumption postoperatively
1-8 days postoperatively

Collaborators and Investigators

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

Sponsor

Aretaieion University Hospital

Collaborators

KAT General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 10, 2019

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

May 22, 2020

First Submitted That Met QC Criteria

May 27, 2020

First Posted (Actual)

May 28, 2020

Study Record Updates

Last Update Posted (Actual)

July 12, 2022

Last Update Submitted That Met QC Criteria

July 10, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Delirium-Pain-Hip Fracture

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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