Femoroacetabular ImpingementNCT02702661

PRCT of FICB vs LAI for Hip Arthroscopy

A study testing Fascia Iliaca Compartment Block (FICB), Local Anaesthetic Infiltration (LAI) and Levobupivacaine in people with Femoroacetabular Impingement, run by Cambridge University Hospitals NHS Foundation Trust.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Femoroacetabular Impingement
What is being tested?: Fascia Iliaca Compartment Block (FICB), Local Anaesthetic Infiltration (LAI) and Levobupivacaine
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 46 participants
Where: No sites listed yet
Study dates: Mar 2013to Apr 2014
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients over the age of 18 years
Primary elective hip arthroscopy on a native hip for combined soft tissue injuries and FAI pathology
Able to read, write and communicate in English

Who cannot join

Patients who did not want to be involved in the Trial
Unable to give informed consent
Previous hip surgery
Patients younger than 18 years of age
Chronic opioids users
Patients known to have an allergy or intolerance to local anaesthetic agents or none steroidal anti-inflammatory medications

About this study

Official title: Fascia Iliaca Compartment Block and Local Anaesthetic Infiltration for Pain Control Following Hip Arthroscopic Surgery

A prospective randomised controlled trial involving patients undergoing hip arthroscopy. Participants were randomised to receiving either Fascia Iliaca Compartment Block (FICB) or Local Anaesthetic Infiltration (LAI) of the portal tracts with local anaesthetic. Supplemental analgesia was also used in both groups on an on-demand basis. Pain level is assessed at 1,3,6, and 24 hours post surgery. The primary outcome measure was the post-operative level of pain as assessed by Numeric Pain Score 6 hours after surgery. Secondary outcome measures were the frequency and the dose of morphine and other medications consumed at 1 and 24 hours after surgery as well as any other adverse events relating to pain or medications used for pain relief in both the groups.

Conditions: Femoroacetabular Impingement
Being tested: Fascia Iliaca Compartment Block (FICB), Local Anaesthetic Infiltration (LAI), Levobupivacaine
Keywords: Fascia Iliaca Block, Local Anaesthetic Infiltration, Hip Arthroscopy
Medical subject headings: Femoracetabular Impingement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fascia Iliaca Compartment Block (FICB)Procedure or surgery
Fascia Iliaca Compartment Block
Local Anaesthetic Infiltration (LAI)Procedure or surgery
Local Anaesthetic Infiltration (LAI) of the portal tracts
LevobupivacaineDrug
Levobupivacaine 0.125% - 40ml

Study groups in NCT02702661
Study group	Role	What they receive
Procedure - FICB	Experimental	Fascia Iliaca Block following Hip Arthroscopy - Drug - Levobupivacaine 0.125% - 40ml Receives: Procedure: Fascia Iliaca Compartment Block (FICB); Drug: Levobupivacaine
Procedure - LAI	Active comparator	Local Anaesthetic Infiltration following Hip Arthroscopy - Drug - Levobupivacaine 0.125% - 40ml Receives: Procedure: Local Anaesthetic Infiltration (LAI); Drug: Levobupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

Level of pain as assessed by Numeric Pain Score
Measured: 6 hours after surgery

Secondary outcomes (4)

Frequency of morphine consumed
Measured: 1 and 24 hours after surgery
Total dose of morphine consumed
Measured: 1 and 24 hours after surgery
Total dose of codeine consumed
Measured: 1 and 24 hours after surgery
Nausea and Vomiting
Measured: 1 and 24 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Apr 2014

First posted9 Mar 2016 (estimated)
Study startMar 2013
Primary completionNov 2013
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Femoroacetabular ImpingementStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02702661
Sponsor's protocol ID: A092336
Status last verified: Mar 2016
First submitted: 24 Feb 2016
Last updated: 11 Mar 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
Not yet recruiting
The Effectiveness of High-intensity Laser Therapy in Femoroacetabular Impingement Syndrome
Femoroacetabular Impingement Syndrome, Femoro-acetabular Impingement
Active, not recruiting
Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications?
Femoroacetabular Impingement Syndrome
Recruiting
Comparison of Surgery With Prehabilitation, Direct Surgery and Rehabilitation for Patients With Femoroacetabular Impingement
Femoroacetabular Impingement Syndrome
Not yet recruitingObservational study
Mapping Joint Damage Patterns in Femoroacetabular Impingement
Femoro-acetabular Impingement (FAI)

All Femoroacetabular Impingement trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fascia Iliaca Compartment Block and Local Anaesthetic Infiltration for Pain Control Following Hip Arthroscopic Surgery
ClinicalTrials.gov ID: NCT02702661
Acronym / sponsor ID: A092336
Conditions: Femoroacetabular Impingement
Keywords: Fascia Iliaca Block, Local Anaesthetic Infiltration, Hip Arthroscopy
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
Study start: Mar 2013
Primary completion: Nov 2013 (actual)
Study completion: Apr 2014 (actual)
First posted: 9 Mar 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Procedure - FICB	Experimental	Procedure: Fascia Iliaca Compartment Block (FICB), Drug: LevobupivacaineFascia Iliaca Block following Hip Arthroscopy - Drug - Levobupivacaine 0.125% - 40ml
Procedure - LAI	Active comparator	Procedure: Local Anaesthetic Infiltration (LAI), Drug: LevobupivacaineLocal Anaesthetic Infiltration following Hip Arthroscopy - Drug - Levobupivacaine 0.125% - 40ml

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients over the age of 18 years
Primary elective hip arthroscopy on a native hip for combined soft tissue injuries and FAI pathology
Able to read, write and communicate in English

Key exclusion criteria (6 listed)

Patients who did not want to be involved in the Trial
Unable to give informed consent
Previous hip surgery
Patients younger than 18 years of age
Chronic opioids users

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fascia Iliaca Compartment Block (FICB)Fascia Iliaca Compartment Block	Procedure or surgery	Procedure - FICB
Local Anaesthetic Infiltration (LAI)Local Anaesthetic Infiltration (LAI) of the portal tracts	Procedure or surgery	Procedure - LAI
LevobupivacaineLevobupivacaine 0.125% - 40ml	Drug	Procedure - FICB, Procedure - LAI

Primary outcome

Level of pain as assessed by Numeric Pain Score
Time frame: 6 hours after surgery

4 secondary outcomes

Frequency of morphine consumed
Time frame: 1 and 24 hours after surgery
Total dose of morphine consumed
Time frame: 1 and 24 hours after surgery
Total dose of codeine consumed
Time frame: 1 and 24 hours after surgery
Nausea and Vomiting
Time frame: 1 and 24 hours after surgery

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
Individual participant dataSharing planned: No

Related trials for Femoroacetabular Impingement

RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
Not yet recruiting
The Effectiveness of High-intensity Laser Therapy in Femoroacetabular Impingement Syndrome
Femoroacetabular Impingement Syndrome, Femoro-acetabular Impingement
Active, not recruiting
Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications?
Femoroacetabular Impingement Syndrome
Recruiting
Comparison of Surgery With Prehabilitation, Direct Surgery and Rehabilitation for Patients With Femoroacetabular Impingement
Femoroacetabular Impingement Syndrome
Not yet recruitingObservational study
Mapping Joint Damage Patterns in Femoroacetabular Impingement
Femoro-acetabular Impingement (FAI)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vikas Khanduja, MA, FRCS (Orth) study director

Cambridge University Hospitals NHS Foundation Trust

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Level of pain as assessed by Numeric Pain Score (time frame: 6 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02702661.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2016.