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

Primary Purpose

Hip Fractures

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Fascia iliaca compartment block
Placebo injection
Sponsored by
United Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring hip fracture, orthogeriatrics, fascia iliaca compartment block

Eligibility Criteria

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • United Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Control group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 25, 2020
Last Updated
May 21, 2023
Sponsor
United Christian Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04478552
Brief Title
Analgesic Effect of Fascia Iliaca Compartment Block in Geriatric Patients With Hip Fracture
Official Title
Randomized Controlled Trial on Analgesic Effect of Pre-operative Fascia Iliaca Compartment Block in Geriatric Patients With Hip Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
September 14, 2021 (Actual)
Study Completion Date
October 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United Christian Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This study is a randomized control, single blinded trial. It tests the hypothesis that fascia iliaca compartment block using local anaesthetic agent for pre-operative analgesia in patients with hip fracture, compared to that using normal saline as control, leads to a better pain control and fewer doses of systemic analgesics required. All patients admitted to United Christian Hospital Orthopaedic and Traumatology ward for hip fracture with radiological diagnosis will be seen by on-call resident. Principal investigator and other investigators will be notified of the admission within 1 working day. Subjects will be recruited according to inclusion and exclusion criteria as mentioned in the below section. Subjects will be recruited only if an informed consent for this study has been signed. Only patients with hip fracture pending emergency operation will be recruited. 2 enclosed envelopes will be prepared, in which one indicates "intervention", and one indicates "control". Subjects will randomly choose any of the envelopes without knowing the intervention/control group assignment. To maintain true randomization, the 2 envelopes will be kept in good condition, preventing identification of the underlying assignment from the outer appearance. Investigators, knowing the group assignment, will then prepare an injection kit set for Fascia iliaca compartment block which includes vials of levobupivacaine, normal saline, syringes, 22G/21G needle, simple dressing set and skin antiseptic solution. For the intervention group, fascia iliaca compartment block with 30ml/40ml 0.25% levobupivacaine, depending on body weight (30ml for body weight less than 50kg, 40ml for body weight more than 50kg), will be performed by investigators under landmark approach. For the control group, same volume of normal saline, instead of levobupivacaine, will injected using the same technique, so that single blinding can be achieved. Subjects' vital signs will be observed for every 10 minutes for 30 minutes after injection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
hip fracture, orthogeriatrics, fascia iliaca compartment block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Fascia iliaca compartment block
Intervention Description
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 Type
Procedure
Intervention Name(s)
Placebo injection
Intervention Description
same volume of normal saline, instead of levobupivacaine, will injected using the same technique.
Primary Outcome Measure Information:
Title
Change in pain in terms of Numeric Rating Scale
Description
Numeric Rating Scale (0-10) whereas 0 is the least pain and 10 is the worst pain
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
United Christian Hospital
City
Kwun Tong
State/Province
Kowloon
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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