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

NCT02689388 | Terminated DMC

• 1 other identifier: ADHB_6925
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium; Hip Fracture

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Decreased recovery time after surgery

  immediately - immediately - 90 days

• Decrease post-operative opioid consumption

  immediately - immediately - 90 days

Study Arms (2)

General Anesthesia with nerve block

ACTIVE COMPARATOR

Femoral Nerve Block

Procedure: Femoral Nerve Block

General Anesthesia no nerve block

NO INTERVENTION

No femoral Nerve Block

Interventions

Femoral Nerve Block PROCEDURE

Use of femoral nerve block as part of general anesthesia

Also known as: Nerve Block, Regional Anesthesia

General Anesthesia with nerve block

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Auckland City Hospital: lead

Study Sites (1)

Auckland City Hopsital

Auckland, 1023, New Zealand

Location

Related Publications (1)

• 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.

  PMID: 33238043 DERIVED

MeSH Terms

Conditions

Delirium; Hip Fractures; Agnosia

Interventions

Nerve Block; Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Perceptual Disorders

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Tin L Chiu, MBChB

  Auckland City Hospital - Anaesthesia and Peri-Operative Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anesthetist

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: February 24, 2016
• Study Start: August 28, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2018
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)