Risk management in soft tissue and joint injections"

Dr Graeme Wilkes

Consultant in Sport & Exercise Medicine

1. Injections risks 2. Novel anti-coagulants 3. DMARDS

Background

1984 – 1989 General medicine

1989 - 2007 General practice

1996 - current Sport Medicine

2007- current NHS Community MSK

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• 359 NHS Community audited

injections in 2014

• Most U/S guided

• Dry needling 21G green

• Steroid often

• No serious (persisting) side-effects

• Good outcomes

COMPLICATIONS OF JOINT, TENDON, AND MUSCLE INJECTIONS Tech Reg Anesth Pain Manag. 2007 Jul; 11(3): 141–147.

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SI joint No reported complications

N/A

Hip and greater trochanteric bursa

Necrotizing fasciitis Air embolism

Hofmeister and Engelhardt, 2001 McCauley et al. 1981

Knee

Pain or swelling at the site of injection Granulomatous inflammation of the synovium Saphenous neuropathy Aseptic acute arthritis Septic arthritis Embolia cutis medicamentosa Albicans arthritis

Chen et al. 2002 Chen et al. 2002 Iizuka et al. 2005 Bernardeau, 2001; Roos et al. 2004 Charalambous et al. 2003; Lequerre et al. 2002; Evanich et al. 2001 Beissert et al. 1999 Christensson et al. 1993

Shoulder Osteomyelitis Necrotising fasciitis Gas gangrene

Buckley et al. 1989 Birkinshaw et al. 1997 Yangco et al. 1982

Carpel tunnel Median nerve injury Linskey and Segal 1990

Injections for athletic injuries

Tendon and fascial ruptures

Nichols, 2005

Trigger point

Pneumothorax Intrathecal injection Epidural abscess Skeletal muscle toxicity

Shafer, 1970; Fitzgibbon et al.

2004 Nelson and Hoffman 1998 Elias 1994 Zink and Graf 2004

Efficacy and safety of corticosteroid injections and other injections for management of tendinopathy: a systematic

review of randomised controlled trials Lancet 2010

Lancet 2010;376:1751–67). 10

• 3824 trials were identified and 41 met inclusion criteria, providing

data for 2672 participants.

• Showed consistent findings between many high-quality

randomised controlled trials that corticosteroid injections reduced

pain in the short term compared with other interventions, but this

effect was reversed at intermediate and long terms.

• Of 991 participants who received corticosteroid injections in

studies that reported adverse events, only one (0·1%) had

a serious adverse event (achilles tendon rupture).

• The review found:

9% cases of atrophy.

8% increased post-injection pain.

<1% depigmentation.

Risk Management Consent form: Coronary Artery Bypass grafting 4. I have been told and understand the risks and benefits of the procedures listed above. I understand that there are all kinds of risks for surgery. These risks, which can be serious include bleeding, infection, and damage to nearby tissues, vessels, nerves or organs. They may result in cardiac arrest, brain damage, paralysis and/or death. Other risks for this procedure include : BLEEDING,INFECTION, HEART ATTACK, STOKE, ARRHYTMIA, KIDNEY DAMAGE,DEATH 5. I understand that the alternative to the proposed procedure and related risks is : medical management

Risk Management

Measures of Likelihood

The following table gives descriptions of the likelihood of a risk occurring

1 Rare May occur only in exceptional circumstances

2 Unlikely Not expected but could occur at some time

3 Possible May/will occur at some time

4 Likely Will probably occur but not a persistent issue

5 Almost Certain Likely to occur on many occasions, a persistent issue

Risk management

Medico-legal issues: • Shared decision making evidenced

• Consent indicated as taken

• Explain common side-effects

• Explain uncommon serious side effects

• Act according to evidence and regulations

• Be up to date

• Be prepared ( Oxygen, anaphylaxis kit, defibrillator)

• Be trained ( on injection and emergency care – e.g. BLS)

• Act in a way that is shared by a reasonable body of your peers

( doesn’t have to be most just some!)

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Side effects/complications of injection therapy The injectate

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1. Post-injection flare (3) Possible

2. Soft tissue atrophy (2) Unlikely

3. Depigmentation (2) Unlikely

4. Vasomotor ( flush) (2) Unlikely

5. Local infection (1) Rare

6. Affect intercurrent infection (1) Rare

7. Allergy / Anaphylaxis (1) Rare

8. Cardiac arrhythmia (1) Rare

Tendon rupture

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“It is difficult to find conclusive

evidence that corticosteroid injection

is directly responsible for tendon

rupture , or whether the rupture in in

fact due to the degenerative disease

process”

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Side effects/complications of injection therapy per 400 injections

The needle

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1. Muscle, tendon, ligament

2. Bone

3. Vein

4. Nerve

5. Artery

6. Thoracic or abdominal organ

Aftercare

• Steroid injection is an adjunct to rehabilitation

• Window of opportunity

• Resume exercises ASAP – 3-5 days

• Resume sport - 5-10 days *

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Endocarditis prophylaxis?

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Endocarditis (from NICE 2008, CG 64)

•Incidence 1 in 10 000

•Mortality 20%

In 2006 the British Society for Antimicrobial Chemotherapy produced

guidance on endocarditis prophylaxis (J Antimicrobial Chemotherapy

2006;57:1035–42). The guidance was written by representatives from the

UK, Europe and the USA. Having reviewed all the evidence they concluded

that the risks of endocarditis are much lower than had previously been

thought and that very few individuals actually need prophylaxis. Now NICE

have produced guidance that is even more radical (NICE CG 64, 2008):

•Nobody requires endocarditis prophylaxis!

22 years of injecting

1. 32 yo admission with cellulitis arm post triceps tendon dry needling, no steroid, patient delayed seeking help

2. 78 yo admission with “shoulder septic arthritis” – all cultures and gram stains negative – probably steroid flare

3. 38 yo “collapse” after high volume saline to achilles – AED pads applied re unable to feel a pulse

4. Numerous vaso-vagal attacks including one incontinent on floor

5. Occasional attendences A&E with severe pain – steroid flare

6. Depigmentation 2-3 per year

7. Fat atrophy – 1-2 per year

8. 56 yo lady with Tachon Syndrome 20

Tachon Syndrome

• Well described but rare

• Severe spinal pain during/just after injection

• UL > LL

• Plantar fascia common in LL

• Thought related to venous injection

• Anxiety (87%), shortness of breath (64%),facial flushing (64%),

• No sequelae

• Very dramatic but short ( 15 mins) !

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Infection/ Antibiotics/ Steroids

Do not inject:

• If systemically acutely unwell ( fever, sweats)

• If active local infection near to site

Injection should be OK if :

• Antibiotics for disease prevention : acne / UTI

• On oral steroids

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Novel Anticoagulants (NOACs) : dabigatran, rivaroxaban and apixaban

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• The NOACs (novel oral anticoagulants) are new drugs that may be used in place of

warfarin.

• They are licenced for

1.Stroke prevention in atrial fibrillation (AF)

2. Prevention of venous thromboembolism (VTE) after hip/knee replacement

3. Treatment of VTE

4. Prevention of recurrence of VTE

Rivaroxiban

Direct factor Xa inhibitor, (factor Xa is central to the coagulation cascade)

NOACs: dabigatran, rivaroxaban and apixaban

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• They are marketed based on needing no monitoring of their effect on coagulation

• No dietary restrictions are required

• Cost £720-£920 pa Warfarin £426 pa including monitoring

• These are new drugs – we have limited data on long-term safety and there is no

agent for rapid reversal in the event of a catastrophic bleed (SIGN 2012, 129).

• They do offer some benefits over warfarin in terms of stroke prevention, but the

benefits are not huge

• There is limited clinical evidence for these drugs either way

NOACs: dabigatran, rivaroxaban and apixaban

So what if your patient needs an injection?

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• No blood testing needed/ available

• Enquire about unexpected bruising or bleeding now or previously

• If none then go ahead!

DMARDS ( Sepsis risk)

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First line treatment for Rheumatoid Arthritis:

•Methotrexate (MTX).

Its first line use is supported by meta-analyses. It improves both clinical

and radiological outcomes and has an acceptable toxicity profile. Typical

gastrointestinal side-effects and liver toxicity can be reduced by folic acid

(or the subcutaneous route).

•Other DMARDs include leflunomide (recent systematic review suggests

as good at MTX), sulfasalazine, hydroxychloroquine, gold, cyclosporin

and azathioprine. All DMARDs require regular monitoring.

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•Corticosteroids. Useful 'bridging drugs', as their fast onset of action can

control the disease whilst a DMARD is being established. Combination of

DMARD and corticosteroid is more effective than either alone but the poor

safety profile of steroids long-term reduces their usefulness.

•Biological agents. Tumour necrosis factor α (TNF-α) inhibitors are

increasingly being used where DMARDs have failed to control. TNF-α

inhibitors with MTX increase the risk of bacterial infections in patients

including re-activation of latent infections such as TB.

DMARDS

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• Must be having regular blood tests ( 3 months if stable)

• DMARDS can affect bone marrow or liver

• Check on latest test – key aspect is FBC – are there enough

white cells ( infection risk) or platelets ( bleeding risk)

To inject or not to inject ?

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Questions