Analgesic Effect of Fascia Iliaca Compartment Block in Geriatric Patients With Hip Fracture

NCT04478552 | Completed DMC

• 1 other identifier: SPv1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

As population in Hong Kong is aging, incidence of geriatrics hip fractures rises. Operative treatment for selective patients offers pain control, early mobilization and reduction in medical morbidities and mortalities. Research has shown that the pain from hip fracture left untreated may have significant physical and psychological effects on the patient, precipitating delirium, especially in elderly patients with hip fractures, and may delay operative management and may complicate hospital stay. Studies report that the pain management for limb fractures in the elderly is hugely sub-optimal with some suggesting that only 2% receive adequate analgesia. Adequate analgesia before definitive treatment of hip fracture may improve mobilization and cognitive performance. As a part of multi-modal pain management, Fascia iliaca compartment block is being increasingly popular as a simple, safe and effective regional technique for patients with hip fractures and proximal femoral shaft fractures, providing consistent analgesic effect for hip fracture patients, irrespective of the performing doctor's experience. This study aims to provide high level local evidence of the effect and efficacy of the fascia iliaca compartment block in preoperative pain control for patients with hip fracture admitted to Orthopaedic and Traumatology ward in United Christian Hospital.

Conditions

Hip Fractures

Keywords

hip fracture; orthogeriatrics; fascia iliaca compartment block

Outcome Measures

Primary Outcomes (1)

• Change in pain in terms of Numeric Rating Scale

  Numeric Rating Scale (0-10) whereas 0 is the least pain and 10 is the worst pain

  on admission, just before fascia iliaca compartment block, 1 hour after injection, 12 hour after injection, 24 hour after injection, and 48 hour after injection.

Study Arms (2)

Intervention group

EXPERIMENTAL

Procedure: Fascia iliaca compartment block

Control group

PLACEBO COMPARATOR

Procedure: Placebo injection

Interventions

Fascia iliaca compartment block PROCEDURE

It involves injecting local anaesthetic agent (levobupivacaine) into the fascia iliaca compartment of the patient, infiltrating three major nerves that supply the medial, anterior and lateral thigh, namely the femoral and lateral femoral cutaneous nerves. This procedure can be done with anatomical landmark approach or under image guidance.

Intervention group

Placebo injection PROCEDURE

same volume of normal saline, instead of levobupivacaine, will injected using the same technique.

Control group

Eligibility Criteria

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

You may qualify if:

• Age 65 or above
• Patients admitted Orthopaedic and Traumatology ward in United Christian Hospital
• Radiographically confirmed unilateral fracture hip
• Patient requiring pre-operative analgesia
• Mentally competent
• Informed consent signed

You may not qualify if:

• Age less than 65
• Presence of more than one fracture
• Patient refusal to participating in this study
• Known true allergy or previous anaphylactic reaction to local anaesthetic
• Previous femoral-bypass surgery, or near a graft site.
• Previous surgery over the injection site
• Inflammation, infection, or hernia over the injection site
• INR \>1.4
• Platelet count \<100x 10\^9/L
• Patient on heparin / fondaparinux / rivaroxaban / dabigatran / ticlopidine / clopidogrel / prasugrel / cilostazol

Sponsors & Collaborators

• United Christian Hospital: lead

Study Sites (1)

United Christian Hospital

Kwun Tong, Kowloon, Hong Kong

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Wan Tze Kit

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: July 20, 2020
• Study Start: June 1, 2019
• Primary Completion: September 14, 2021
• Study Completion: October 14, 2021
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)