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

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.

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.

Study Overview

• Status: Terminated
• Conditions: Delirium; Hip Fracture
• Intervention / Treatment: Procedure: Femoral Nerve Block

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland City Hopsital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: General Anesthesia with nerve block; Femoral Nerve Block	Procedure: Femoral Nerve Block; Use of femoral nerve block as part of general anesthesia; Other Names: Nerve Block; Regional Anesthesia
No Intervention: General Anesthesia no nerve block; No femoral Nerve Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	immeidately to 5 days post operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decreased recovery time after surgery	reduction in length of stay and recovery time	immediately - immediately - 90 days
Decrease post-operative opioid consumption	reduction in the requirement for systemic/opiod analgesia	immediately - immediately - 90 days

Collaborators and Investigators

• Sponsor: Auckland City Hospital
• Investigators: Principal Investigator: Tin L Chiu, MBChB, Auckland City Hospital - Anaesthesia and Peri-Operative Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2016
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: February 18, 2016
• First Submitted That Met QC Criteria: February 18, 2016
• First Posted (Estimate): February 24, 2016

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: analgesia; femoral nerve block; regional analgesia; older persons; frail
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Leg Injuries; Femoral Fractures; Hip Injuries; Delirium; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: ADHB_6925

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no current plan to share individual subject data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No