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Evaluating the Addition of Regional Analgesia to Reduce Postoperative Delirium in Patients Having Hip Fracture Surgery. (RASAPOD)

Primary Purpose

Delirium, Hip Fracture

Status

Terminated

Phase

Not Applicable

Locations

New Zealand

Study Type

Interventional

Intervention

Femoral Nerve Block

About this trial

This is an interventional prevention trial for Delirium focused on measuring analgesia, regional analgesia, femoral nerve block, older persons, frail

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria (must meet all 3):

Greater than or equal to 65 years
Have a hip fracture requiring surgery
Written informed consent for participation of study prior to surgery.

Exclusion criteria:

Contraindication to peripheral nerve block or local anaesthetics
Unable to do delirium or cognitive testing due to language, vision or hearing impairment
Unable to communicate with research staff due to language barriers
History of chronic opioid use (longer than 1 month)
Contraindication to general anesthesia

Sites / Locations

Auckland City Hopsital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

General Anesthesia with nerve block

General Anesthesia no nerve block

Arm Description

Femoral Nerve Block

No femoral Nerve Block

Outcomes

Primary Outcome Measures

The incidence of post-operative delirium after hip fracture surgery

Identify the our local incidence of post operative delirium diagnosed with 3D-CAM (3 Minute Diagnostic Assessment for Confusion Assessment Method)

Secondary Outcome Measures

Decreased recovery time after surgery

reduction in length of stay and recovery time

Decrease post-operative opioid consumption

reduction in the requirement for systemic/opiod analgesia

Full Information

NCT ID

NCT02689388

First Posted

February 18, 2016

Last Updated

July 21, 2021

Sponsor

Auckland City Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02689388

Brief Title

Evaluating the Addition of Regional Analgesia to Reduce Postoperative Delirium in Patients Having Hip Fracture Surgery.

Acronym

RASAPOD

Official Title

The Use of Post-operative Regional Analgesia Rather Than Systemic Analgesia to Decrease the Incidence of Post-operative Delirium After Acute Hip Fracture Surgery? A Prospective Randomized-controlled Double-blinded Pilot Study.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Terminated

Why Stopped

Feasibility

Study Start Date

August 28, 2016 (Actual)

Primary Completion Date

December 31, 2017 (Actual)

Study Completion Date

December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Auckland City Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Post operative delirium is common after hip fracture surgery and is associated with increased length of hospital stay, delayed recovery and increased mortality. Postoperative delirium can also decrease a patient's quality of life and increase treatment costs. Anesthesia and pain relief (analgesia) treatments may also influence the incidence of delirium, but more research is needed into which techniques are effective in improving patient outcomes, care and decreasing costs. This pilot study compares the addition of regional analgesia as part of general anesthesia to determine the incidence of delirium following hip surgery. This is a collaborative study involving anesthesia, orthopedic surgery and geriatrics in the improvement of patient care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Delirium, Hip Fracture

Keywords

analgesia, regional analgesia, femoral nerve block, older persons, frail

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

General Anesthesia with nerve block

Arm Type

Active Comparator

Arm Description

Femoral Nerve Block

Arm Title

General Anesthesia no nerve block

Arm Type

No Intervention

Arm Description

No femoral Nerve Block

Intervention Type

Procedure

Intervention Name(s)

Femoral Nerve Block

Other Intervention Name(s)

Nerve Block, Regional Anesthesia

Intervention Description

Use of femoral nerve block as part of general anesthesia

Primary Outcome Measure Information:

Title

The incidence of post-operative delirium after hip fracture surgery

Description

Identify the our local incidence of post operative delirium diagnosed with 3D-CAM (3 Minute Diagnostic Assessment for Confusion Assessment Method)

Time Frame

immeidately to 5 days post operatively

Secondary Outcome Measure Information:

Title

Decreased recovery time after surgery

Description

reduction in length of stay and recovery time

Time Frame

immediately - immediately - 90 days

Title

Decrease post-operative opioid consumption

Description

reduction in the requirement for systemic/opiod analgesia

Time Frame

immediately - immediately - 90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria (must meet all 3): Greater than or equal to 65 years Have a hip fracture requiring surgery Written informed consent for participation of study prior to surgery. Exclusion criteria: Contraindication to peripheral nerve block or local anaesthetics Unable to do delirium or cognitive testing due to language, vision or hearing impairment Unable to communicate with research staff due to language barriers History of chronic opioid use (longer than 1 month) Contraindication to general anesthesia

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tin L Chiu, MBChB

Organizational Affiliation

Auckland City Hospital - Anaesthesia and Peri-Operative Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Auckland City Hopsital

City

Auckland

ZIP/Postal Code

1023

Country

New Zealand

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is no current plan to share individual subject data

Citations:

PubMed Identifier

33238043

Citation

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.

Results Reference

derived

Learn more about this trial

Evaluating the Addition of Regional Analgesia to Reduce Postoperative Delirium in Patients Having Hip Fracture Surgery.

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