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Enhanced Recovery After Cardiac Surgery (ERAS)

J

James Cook University Hospital

Status

Unknown

Conditions

Mitral Valve Disease
Coronary Artery Disease
Cardiac Surgery
Aortic Root Dilatation
Aortic Valve Disease
Tricuspid Valve Disease

Treatments

Drug: Post-operative Ondansetron anti-emesis
Dietary Supplement: Pre-operative Carbohydrate PreLoad drink
Drug: Intravenous Ondansetron intra-operatively
Procedure: Early mobilisation/physiotherapy
Drug: Intravenous Magnesium intra-operatively
Procedure: Early extubation
Drug: Intravenous Paracetamol intra-operatively
Drug: Infiltration of surgical wounds with local anaesthetic
Drug: Oral Gabapentin pre-op
Drug: Oral Lansoprazole pre-op
Drug: Post-operative Gabapentin analgesia
Other: Encourage early oral food intake
Drug: Intravenous Dexamethasone intra-operatively
Drug: Post-operative oral Paracetamol analgesia

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03859102
IRAS242926

Details and patient eligibility

About

Enhanced Recovery Protocols (ERPs or bundles) have been established in many surgical specialties (such as colon cancer and orthopaedic joint surgeries) for several years in hospitals worldwide. The principles of Enhanced Recovery Protocols are those of early mobilization and restoration of normal function as soon as possible after surgery. These principles are achieved by use of alternate pain control regimens and removing invasive lines and drains as soon as possible. The benefits of ERPs are improved patient experience, earlier return to normal function and reduced length of stay. Enhanced recovery protocols for cardiac surgery have been published by the Enhanced Recovery After Cardiac Surgery Society.

The current study will investigate whether it is possible to utilise ERP bundles in the population of cardiac surgery patients at James Cook Hospital, with a view to rolling out a full ERP service. Secondary study outcomes will be patient-centred, including; pain scores, nausea and vomiting rates and time taken to return to normal function.

Full description

Why? Enhanced Recovery Protocols (ERPs or bundles) have been established in many surgical specialties (such as colon cancer and orthopaedic joint surgeries) for several years in hospitals worldwide. The principles of Enhanced Recovery Protocols are those of early mobilization and restoration of normal function as soon as possible after surgery. These principles are achieved by use of alternate pain control regimens and removing invasive lines and drains as soon as possible. The benefits of ERPs are improved patient experience, earlier return to normal function and reduced length of stay. Enhanced recovery protocols for cardiac surgery have been published by the Enhanced Recovery After Cardiac Surgery Society. These protocols have been demonstrated as safe, though have yet to make it into mainstream practice in the UK. The use of ERPs in Cardiac Surgery has the potential to greatly improve the patient journey and hospital efficiency.

What? The current study will investigate whether it is possible to utilise ERP bundles in the population of cardiac surgery patients at James Cook Hospital, with a view to rolling out a full ERP service. Secondary study outcomes will be patient-centred, including; pain scores, nausea and vomiting rates and time taken to return to normal function.

Who? All adult patients over the age of 18 years and listed for cardiac surgery will be considered for inclusion in this study.

Where? The study population will be comprised of patients undergoing cardiac surgery at the James Cook University Hospital in Middlesbrough.

How? Study duration will be 6 months, with 80 patients (comprising a control and intervention group)

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Having Cardiac Surgery
  • Aged 18 years or older at the time of consent
  • Deemed appropriate for ERAS by Surgeon and Anaesthetist
  • Able and willing to provide written informed consent

Exclusion criteria

  • Aged 18 years or under
  • Deemed not suitable for ERAS by Surgeon and/or Anaesthetist

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

80 participants in 2 patient groups

ERAS Control/non-ERAS group
No Intervention group
Description:
Standard usual care after cardiac surgery.
ERAS group
Experimental group
Description:
Enhanced Recovery After Cardiac Surgery. Pre-op carbohydrate drink, Lansoprazole and Gabapentin. Intra-operative: IV Paracetamol, Dexamethasone, Ondansetron, Local Anaesthetic to wounds. Post-op: Gabapentin PO, Paracetamol IV then PO, Ondansetron IV for 24hrs. Opiate sparing. Early extubation, early mobilisation, early removal of invasive devices. Early discharge.
Treatment:
Procedure: Early mobilisation/physiotherapy
Drug: Post-operative Ondansetron anti-emesis
Procedure: Early extubation
Drug: Post-operative Gabapentin analgesia
Drug: Infiltration of surgical wounds with local anaesthetic
Drug: Intravenous Paracetamol intra-operatively
Dietary Supplement: Pre-operative Carbohydrate PreLoad drink
Drug: Oral Gabapentin pre-op
Other: Encourage early oral food intake
Drug: Intravenous Magnesium intra-operatively
Drug: Intravenous Ondansetron intra-operatively
Drug: Intravenous Dexamethasone intra-operatively
Drug: Post-operative oral Paracetamol analgesia
Drug: Oral Lansoprazole pre-op

Trial contacts and locations

1

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Central trial contact

Adrian Mellor, MBBS; Jim C Coates, MBBS

Data sourced from clinicaltrials.gov

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