Condition category
Musculoskeletal Diseases
Date applied
22/07/2016
Date assigned
26/07/2016
Last edited
26/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A hip fracture is where there is a break in the upper thigh bone (femur). They are very common, particularly in older adults, and are extremely painful. A nerve block is a type of treatment in which a local anaesthetic (numbing) fluid is injected into the area that is painful in order to relieve pain. A Fascia Iliaca Compartment Block (FICB) is a type of nerve block in which the anaesthetic is injected into the space below the layer of muscle at the top of the leg. This study compares a new way of administering this injection, in which the anaesthetic is injected above the inguinal ligament (band of tissue) in the groin (supra-inguinal FICB) rather than below it, as in normal practice. The aim of this study is to compare the effectiveness of pain relief in patients treated using this new technique.

Who can participate?
Adults with a broken hip who are being treated with nerve block injection for pain relief.

What does the study involve?
All participants receive pain management treatment with a supra-inguinal FICB. Each participant is asked to rate their pain with a number on a scale of 0 (no pain) to 10 (most severe pain imaginable) before the injection and then 30, 60 and 120 minutes afterwards. Participants are assessed and reviewed by the medical staff so that their need for other pain medication (and what they had already been given), side effects and type of hip fracture can be recorded.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating, as the study does not change the treatment participants receive as part of their standard care.

Where is the study run from?
Academic Medical Center (Netherlands)

When is the study starting and how long is it expected to run for?
January 2014 to July 2015

Who is funding the study?
Academic Medical Center (Netherlands)

Who is the main contact?
Mr Milan Ridderikhof
m.l.ridderikhof@amc.uva.nl

Trial website

Contact information

Type

Scientific

Primary contact

Mr Milan Ridderikhof

ORCID ID

http://orcid.org/0000-0002-1561-7252

Contact details

Academic Medical Center
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 20 5663336
m.l.ridderikhof@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SuprainguinalFICB14

Study information

Scientific title

Supra-inguinal fascia iliaca compartment block for analgesia in hip fracture patients in the Emergency Department: A case series

Acronym

Study hypothesis

Administration of the supra-inguinal FICB would cause a significant reduction in NRS pain scores.

Ethics approval

The Institutional Review Board (IRB) of the AMC waived the need for official ethics approval as the Medical Research Involving Human Subjects Act (WMO) does not apply to the study.

Study design

Prospective observational case series

Primary study design

Observational

Secondary study design

Case series

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Hip fracture

Intervention

Each patient will receive care as usual, which is pain treatment using a (supra-inguinal) FICB. NRS pain scores will be followed-up strictly and asked for at baseline, as well as 30, 60 and 120 in minutes after administration of the FICB while in rest and with careful movement of the injured extremity. Patients will be questioned whether they experience any adverse events, while continuous three-lead monitoring and pulsoxymetry is continued. Patients will be asked at each NRS-pain question whether they would like additional analgesia as well. Observation and follow-up ends at the moment of discharge from the Emergency Department. Patients will receive hip fracture care as usual (admittance and surgery).

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Number of participants with a three-point decrease in Numerical Rating Scale (NRS) pain scores is measured at any time point after administration of the FICB (at 30, 60 or 120 minutes) compared to baseline NRS pain score.

Secondary outcome measures

1. Decrease in Numerical Rating Scale (NRS) pain scores for different fracture types is measured at 30, 60 and 120 minutes after administration of the FICB
2. Need for additional opioid analgesics is measured by emergency department and anesthesiology staff members, as well as members of the research team at 30, 60 and 120 minutes
3. . Occurrence of side effects is measured by emergency department and anesthesiology staff members, as well as members of the research team at 30, 60 and 120 minutes

Overall trial start date

01/01/2014

Overall trial end date

31/07/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult (18 years or older) patients
2. Radiologically confirmed hip fracture
3. Will be treated with a supra-inguinal FICB in the ED

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Allergies for local anesthetics
2. Polytrauma patients
3. Not receiving a supra-inguinal FICB

Recruitment start date

01/05/2014

Recruitment end date

30/03/2015

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Center

Sponsor details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 20 5663336
m.l.ridderikhof@amc.uva.nl

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Center

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

A manuscript with the results will be submitted for publication in a peer-reviewed medical journal.

Intention to publish date

01/06/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes