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

Delirium Clinical Trial

— 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02689388
• Other study ID #: ADHB_6925
• Status: Terminated
• Phase: N/A
• Start date: August 28, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2021
• Source: Auckland City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Procedure:
• Femoral Nerve Block
Use of femoral nerve block as part of general anesthesia

Locations

Country	Name	City	State
New Zealand	Auckland City Hopsital	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Auckland City Hospital

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Decreased recovery time after surgery	reduction in length of stay and recovery time	immediately - immediately - 90 days
Secondary	Decrease post-operative opioid consumption	reduction in the requirement for systemic/opiod analgesia	immediately - immediately - 90 days