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Trial registered on ANZCTR


Registration number
ACTRN12615001170516
Ethics application status
Approved
Date submitted
3/10/2015
Date registered
2/11/2015
Date last updated
16/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can Enhanced Recovery After Surgery (ERAS) principles be implemented in an Australian healthcare setting to improve patient recovery after total hip replacement (THR)?
Scientific title
Prospective interventional trial using a ‘before-and-after’ design with historical controls to compare the recovery after THR of the standard care group of patients to the ERAS group of patients, as measured by Quality of Recovery-15 score.
Secondary ID [1] 287594 0
Nil known
Universal Trial Number (UTN)
Trial acronym
RECOVER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
total hip replacement 296394 0
total hip arthroplasty 296395 0
anaesthesia 296396 0
recovery after anaesthesia 296397 0
perioperative medicine 296398 0
postoperative analgesia 296399 0
Condition category
Condition code
Anaesthesiology 296666 296666 0 0
Anaesthetics
Anaesthesiology 296667 296667 0 0
Pain management
Musculoskeletal 296668 296668 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The exposed group is the group of patients undergoing THR with ERAS principles of care (October 2015 to April 2016).
The ERAS 'bundle' consists of several measures to be implemented
1. Preoperative patient information regarding the ERAS bundle. A leaflet will be given to patients by the surgeon at the time of booking for surgery.
2. Reduced fasting from clear fluids preoperatively (from midnight of the day of surgery, to 2 hours preoperative)
3. Reduced fasting from clear fluids postoperatively (from 4 hours after surgery, to 'as soon as awake and tolerating oral fluids').
4. Anaesthetic technique to reduce postoperative drowsiness (spinal and propofol sedation or general anaesthesia)
5. Intraoperative antiemetics (dexamethasone 4mg intravenously and granisetron 1mg intravenously)
6. Use of forced air warmer ('Cocoon' forced air warming blanket over nonoperative part of patient) and fluid warmer ('Hotline' fluid warmer to warm intravenous fluids) intraoperatively.
7. Cefazolin 2g intravenously at least 15 minutes preincision
8. Regular postoperative multimodal oral analgesia (Panadol Osteo 2 tablets 8 hourly, meloxicam 15mg daily, Targin 10/5 or 20/10 twice daily) until no longer required for postoperative pain relief. Other oral analgesics as required.
9. Regular postoperative antiemetics for 24 hours (5HT-antagonist of choice - either granisetron 1mg intravenously twice daily or ondansetron 4mg intravenously twice daily).
10. Regular postoperative aperients (coloxyl with senna 2 tablets orally twice daily) until no longer required.
11. Clexane 40mg subcutaneously daily, for 21 days postoperatively.
12. Standardised mobilisation physiotherapy plan:
Day 0 – mobilise on frame with physiotherapist
Day 1 – mobilise on elbow crutches with physiotherapist, sit out of bed, shower with/without assistance
Day 2 – independently mobilise with elbow crutches >50m, independent self-care activities
Day 3 – independently transfer and mobilise with elbow crutches >100m, have a clear understanding of post-discharge progression of ambulation/exercise program and hip precautions. If applicable, independent with stairs and car transfers.
* duration of each session is approximately 20 minutes, however will vary according to patient's ability to mobilise (varies with pain, nausea, dizziness). Data regarding factors that inhibit mobilisation will be collected.

We will measure the implementation of the ERAS bundle (data collection as a process outcome on the Case Report Form) and whether implementation has improved patient recovery (Quality of Recovery-15 score).
Intervention code [1] 292994 0
Treatment: Other
Intervention code [2] 293082 0
Treatment: Drugs
Intervention code [3] 293083 0
Rehabilitation
Comparator / control treatment
The comparator group is the group of patients undergoing THR with standard care (January to September 2015).

Standard care received:
1. Inconsistent preoperative patient information
2. Fasting from oral fluids from 6-18 hours preoperatively.
3. Postoperative oral intake commencing from 4-6 hours postoperatively.
4. Occasional use of intraoperative antiemetics
5. A wide range of prescribed postoperative analgesia, e.g. paracetamol and antiinflammatories only as required, intramuscular or intravenous morphine
6. Postoperative antiemetics given as required, but infrequently.
7. Postoperative laxatives given too late e.g. postoperative day 5.
Control group
Historical

Outcomes
Primary outcome [1] 296275 0
Quality of Recovery-15 (QoR15) score - a commonly used and validated score to assess global domains of early postoperative quality of recovery. It consists of 15 questions on the patient’s health status in the past 24 hours, each answered by patient self-report on a scale of 0-10 to give a total score out of 150. The questions are ‘able to breath easily’, ‘been able to enjoy food’, ‘feeling rested’, ‘have had a good sleep’, ‘able to look after personal toilet and hygiene unaided’, ‘able to communicate with family or friends’, ‘getting support from hospital doctors and nurses’, able to return to work or usual home activities’, ‘feeling comfortable and in control’, ‘having a feeling of general well-being’, ‘moderate pain’, ‘severe pain’, ‘nausea or vomiting’, ‘feeling worried or anxious’, and ‘feeling sad or depressed’.
Timepoint [1] 296275 0
6 weeks postoperatively
Secondary outcome [1] 318025 0
Numerical Rating Score (NRS) assessing the NRS as 0 = worst pain at rest and on movement to 10 = no pain at rest and on movement.
Timepoint [1] 318025 0
Postoperative day 1, postoperative day 2, postoperative week 6
Secondary outcome [2] 318026 0
Analgesia and morphine equivalent consumption - assessed by review of drug chart
Timepoint [2] 318026 0
Postoperative day 1 and 2
Secondary outcome [3] 318027 0
Quality of Recovery-15 (QoR15) score - a commonly used and validated score to assess global domains of early postoperative quality of recovery. It consists of 15 questions on the patient’s health status in the past 24 hours, each answered by patient self-report on a scale of 0-10 to give a total score out of 150. The questions are ‘able to breath easily’, ‘been able to enjoy food’, ‘feeling rested’, ‘have had a good sleep’, ‘able to look after personal toilet and hygiene unaided’, ‘able to communicate with family or friends’, ‘getting support from hospital doctors and nurses’, able to return to work or usual home activities’, ‘feeling comfortable and in control’, ‘having a feeling of general well-being’, ‘moderate pain’, ‘severe pain’, ‘nausea or vomiting’, ‘feeling worried or anxious’, and ‘feeling sad or depressed’.
Timepoint [3] 318027 0
postoperative day 1 and 2
Secondary outcome [4] 318028 0
Mobility as assessed by the 10 Metre Walk Test - time taken to complete the 10 metre walk test measured in minutes and seconds by the treating physiotherapist
Timepoint [4] 318028 0
postoperative day 2
Secondary outcome [5] 318029 0
hospital length of stay - from hospital's inpatient electronic database.
Timepoint [5] 318029 0
day of discharge
Secondary outcome [6] 318030 0
World Health Organisation Disability Assessment Schedule 12 item version 2.0 (WHODAS 2.0)
Timepoint [6] 318030 0
6 weeks postoperatively
Secondary outcome [7] 318031 0
Major complications up to 6 weeks that cause the patient to seek treatment from health care providers. They are wound infection, prosthesis infection, joint dislocation, deep vein thrombosis, pulmonary embolus, acute myocardial infarct, transient ischaemia attack, stroke, acute kidney injury, acute pulmonary oedema, exacerbation of chronic pulmonary disease.
Measured by patient self-report at 6 week telephone call. All reports of the above complications will be confirmed with the treating doctor or hospital.
Timepoint [7] 318031 0
Week 6 postoperatively
Secondary outcome [8] 318032 0
Hospital readmission - measured by patient self-report at 6 week telephone call. All reports of readmissions will be confirmed with the treating hospital.
Timepoint [8] 318032 0
up to 6 weeks postoperatively
Secondary outcome [9] 318033 0
Adherence to the ERAS bundle, measured for each patient in the ERAS (exposed) group. This is preoperative patient information, reduced fasting from oral intake preoperatively and postoperatively, standardised anaesthetic technique (spinal and propofol sedation or general anaesthesia), intraoperative forced air and fluid warmers, regular postoperative multimodal oral analgesia, regular intraoperative and postoperative antiemetics, antibiotic prophylaxis, thromboprophylaxis, regular postoperative aperients, standardised physiotherapy mobilisation plan.
This information is collected on the patient's Case Report Form, from patient self-report, contemporaneous intraoperative data and review of drug charts and hospital medical records.
Timepoint [9] 318033 0
Day of discharge

Eligibility
Key inclusion criteria
1. Patients over the age of 18 years at time of THR.
2. Patients undergoing unilateral THR.
3. Patients who can independently complete the study questionnaires.
4. Patients who have provided written informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who have previously been enrolled in the study at any time.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is a prospective interventional study using a before-and-after design, with two groups of patients. The first group of patients receiving the existing standard of care (pre-intervention group) will act as a historical control group for the second ‘post-intervention’ group of patients.

Data was collected from the preintervention (comparator) group from January to September 2015. Data from the post intervention group will commence in October 2015.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Data will be analysed using contemporary regression methods intended for longitudinal data, allowing for potential confounders such as age, gender and possible differences between the groups. Logistic regression will be employed for binary outcomes such as whether or not day 0 mobilization was possible, robust or median regression for variables with skewed distributions such as length of stay. Tests of statistical significance will be 2 tailed, and employ a criteria of p <= 0.05. 95% confidence intervals will be reported throughout.
No interim analysis is planned.

The sample size of each group is estimated to be 100 per group, assuming 80% statistical power, 0.05 level of statistical significance and a standardized difference between the pre and post-ERAS groups on mean QoR-15 at 6 week follow-up (where maximum change would be expected) of 0.40 of a standard deviation, slightly under the effect size conventionally regarded as ‘medium’.. Calculations were performed using SAS Power and Sample Size 13.1. The expected effect size is a conservative one, suggested by examination of the literature and discussion with the developer of the QoR-15. A 6 point difference in QoR-15 at 6 weeks postoperatively is a clinically significant difference, with an estimated standard deviation of 15 (data from the first phase will be used to calculate SD). Allowing for 10% attrition 111 patients, conservatively rounded to 115, per group would be required.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4421 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 10634 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 292159 0
Hospital
Name [1] 292159 0
Epworth Richmond
Address [1] 292159 0
89 Bridge Rd
Richmond
Vic 3121
Country [1] 292159 0
Australia
Funding source category [2] 292160 0
Commercial sector/Industry
Name [2] 292160 0
Medacta
Address [2] 292160 0
Unit F37, 16 Mars Road
Lane Cove West
Sydney NSW 2066
Country [2] 292160 0
Australia
Primary sponsor type
Individual
Name
Nicole Tan
Address
Anaesthetic Services
Suite 3.4, The Epworth Centre
32 Erin St
Richmond
Vic 3121
Country
Australia
Secondary sponsor category [1] 290835 0
None
Name [1] 290835 0
None
Address [1] 290835 0
None
Country [1] 290835 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293635 0
Epworth HealthCare
Ethics committee address [1] 293635 0
Ground Floor, Pelaco Building Two
21-31 Goodwood Street
Richmond Vic 3121
Ethics committee country [1] 293635 0
Australia
Date submitted for ethics approval [1] 293635 0
10/11/2014
Approval date [1] 293635 0
20/11/2014
Ethics approval number [1] 293635 0
LR146-14

Summary
Brief summary
Patients who undergo total hip replacement surgery traditionally have long surgical incisions, routine urinary catheters and wound drain tubes. Anesthesia involves 12 hours of oral restriction before and after surgery, a combination of local anesthetic blocks, spinal anaesthesia and sedation or general anesthesia. After surgery, patients have varying degrees of immobilization to avoid the risk of early hip dislocation and opioid pain relief which results in slow recovery and hospital discharge at day 4-6.
Enhanced Recovery After Surgery (ERAS) principles for joint replacement surgery involve patient education, less invasive surgery, reduced fasting, regular oral analgesia and early ambulation. These principles are packaged together in a ‘bundle’ individualised for a particular hospital unit to account for local practices and preferences. Most ERAS programs have shown a remarkable improvement in patient recovery after joint replacement as measured by decreased hospital length of stay, improved mobilisation and patient satisfaction, with no increase in complications.
This study aims to implement and evaluate a tailored ERAS program at Epworth HealthCare, a large private hospital with patients undergoing one-sided THR surgery by a single surgeon. Patients enrolled in the study will be evaluated from the time they are seen in the hospital preoperatively to discharge and followed up by a telephone call at 6 weeks. WHODAS 2.0 and QoR-15 questionnaires will assess patients’ return to health. The recovery of this group of patients will be compared to the recovery of a group of patients who underwent THR before the ERAS program was implemented.

Trial website
None
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60790 0
Dr Nicole Tan
Address 60790 0
Anaesthetic Services
Suite 3.4, The Epworth Centre
32 Erin St
Richmond
Vic 3121
Country 60790 0
Australia
Phone 60790 0
+61394277899
Fax 60790 0
Email 60790 0
niki.tan@anaestheticservices.com.au
Contact person for public queries
Name 60791 0
Ms Donna McCallum
Address 60791 0
Ground Floor
Smorgon Institute for Education and Research at Epworth
185-187 Hoddle Street
Richmond VIC 3121
Country 60791 0
Australia
Phone 60791 0
+61399368067
Fax 60791 0
Email 60791 0
donna.mccallum@epworth.org.au
Contact person for scientific queries
Name 60792 0
Dr Nicole Tan
Address 60792 0
Anaesthetic Services
Suite 3.4, The Epworth Centre
32 Erin St
Richmond
Vic 3121
Country 60792 0
Australia
Phone 60792 0
+61394277899
Fax 60792 0
Email 60792 0
niki.tan@anaestheticservices.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary