Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02897934 |
| Other study ID # |
ECM4(h)031115 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 2016 |
| Est. completion date |
July 31, 2018 |
Study information
| Verified date |
January 2021 |
| Source |
University College Cork |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The objectives of this work are threefold:
1. To evaluate the analgesic efficacy of CWI in women discharged within 23 hours of major
breast cancer surgery
2. To evaluate objective indices of patient recovery following anaesthesia and surgery in a
23 hour model of care
3. To evaluate patient satisfaction with their care pathway
Description:
Cork University Hospital is a designated cancer centre, under the national Cancer Control
Programme treating in excess of 560 new cases of breast cancer each year. Breast surgery is
performed by five specialist breast surgeons, with patients accessing services from either
the National Cancer Screening Programme (BreastCheck) or via referral from family physicians
to the rapid access symptomatic breast assessment unit. Both acute and persistent pain
following incisional breast surgery is a significant problem. In the past, it has been
reported that up to 50% of women undergoing incisional breast surgery experience significant
pain immediately following surgery. One in three women may develop persistent post surgical
pain lasting greater than 3 months. The use of multimodal analgesic regimen to include
non-steroidal anti-inflammatories, paracetamol, low dose opiates and importantly local
anaesthetic techniques have seen a significant improvement in post-operative pain management
following incisional breast surgery. Local anaesthetic techniques such as paravertebral
blockade have become commonplace in the management of pain following major incisional breast
surgery.
Current budgetary difficulties have brought increased pressures to bear upon the use and
availability of hospital beds. This has resulted in a shift from an inpatient model of care
to a day case model. More than 85% of all breast cancer surgery is performed as day cases
(same day admission/discharge). The remainder of breast cancer surgeries require a same day
admission with variable length of stay post-operatively. Pain is a significant determinant of
length of post operative stay. Patients with moderate to severe pain are less independent,
require assistance with basic care, consume opiate analgesics, suffer opiate-related side
effects, are less compliant with post-operative physiotherapy and consume more healthcare
resources than patients with mild or no pain. Therefore the design and implementation of an
effective pain management strategy for women undergoing major incisional breast surgery is an
essential component to the overall perioperative patient care pathway.
Since 2010, patients undergoing major incisional breast surgery through BreastCheck at Cork
University Hospital have received a multimodal analgesic regimen during and following surgery
which is based upon the use of local anaesthetic continuous wound infiltration (CWI). The
efficacy of CWI following mastectomy has been found to be equivalent to the gold standard
paravertebral block. Similarly, the efficacy of CWI in women undergoing axillary lymph node
dissection has previously been demonstrated. The clinical experience of women undergoing
mastectomy with axillary clearance or sentinel node surgery suggest equivalence between
paravertebral analgesia and CWI.
Since January 2013, women undergoing major breast cancer surgery at Cork University Hospital
have been enrolled in a prospective cohort study to evaluate the efficacy of an enhanced
perioperative pathway. Elements of this pathway include improved process flow with the
establishment of dedicated preoperative assessment and preadmission clinics, day of surgery
hospital admission and an admission lounge adjacent to the operating theatres, standardised
anaesthesia, analgesia and surgical protocols, goal based immediate post-operative recovery,
early independent ambulation and enteral nutrition, active discharge planning and early
assessment of hospital discharge readiness. Although women following major breast cancer
surgery achieve hospital discharge readiness scores early, the length of hospital stay is
determined by institutional and individual clinician convention, rather than objective
assessment of home readiness.
Parallel to work on the enhanced perioperative pathway, clinicians at Cork University
Hospital have devised APP based technology which will be integrated into the perioperative
pathway. Prior to surgery, the APPs will provide both clinician and user generated
educational material relating to first person perspective on perioperative experiences. In
the post-operative phase, the technology will enable clinicians to monitor and interact with
patients remotely, thereby facilitating early hospital discharge. The technology will also
enable patients to communicate anonymously with each other, generating contemporaneous
communities of recovery.
The objectives of this work are threefold:
to identify, characterise and manage barriers to safe discharge within 23 hours of major
breast cancer surgery; to evaluate the feasibility of discharging a select cohort of patients
at 23 hours following major breast cancer surgery with indwelling CWI as the mainstay of post
operative analgesia to evaluate the analgesic efficacy of CWI in women discharged within 23
hours of major breast cancer surgery
Primary Endpoint:
The analgesic efficacy and safety of CWI in women discharged home within 23 hours of major
breast cancer surgery as assessed by patient reported pain scores 24 and 48 hours discharge,
and surveillance to detect adverse events associated with CWI use.
Secondary Endpoints:
Quality of recovery at 24 & 48 hours (QoR 40) Analgesic Consumption at 24 & 48 hours Wound
drain output at 24 & 48 hours Patient Satisfaction Score
Preoperatively, patients will be screened at the preassessment clinic and their suitability
for 23 hour discharge will be assessed according to institutional norms. The patients will
receive preoperative, nurse delivered education regarding wound care and wound drain
management. A mutually agreed discharge plan will be designed between the patient and the
multidisciplinary team. The patient will receive their perioperative technology device and
become familiar with the educational and communications functionality contained within.
On the day of surgery patients will be admitted to the operating theatre day of surgery area
(DOSA). In DOSA they will have the opportunity to meet the perioperative team again and ask
any outstanding questions. They will then change into a theatre gown and enter the operating
theatre.
This patient cohort will receive standard propofol TIVA (T4 TIVA protocol attached). With
standard monitoring in place (pulse oximetry, electrocardiography, non-invasive arterial
blood pressure and inspired and end- tidal partial pressures of O2 and CO2), patients will
receive preinduction Fentanyl 100mcg and Midazolam 2mg. Entropy processed frontal lobe EEG
monitoring will be attached. Anaesthesia will be induced with propofol target controlled
infusion (Marsh Algorithm; 4-6mcg/ml dose range using 2% Propofol) and the lungs will be
assist ventilated in 65% oxygen/air mixture. Airway and intraoperative fluid management is
entirely at the discretion of the responsible consultant anaesthetist.
Intraoperative analgesia:
Patients will receive Diclofenac 75mg and Paracetamol 1g during surgery. Administration of
intraoperative morphine up to 0.1mg/kg will be at the discretion of the consultant
anaesthetist. All patients will be given PONV prophylaxis with ondansetron 4mg and
dexamethasone 8mg intraoperatively.
Wound soakage with 40ml of 0.25% bupivacaine with 1:200,000 adrenaline will be performed by
the surgeon, allowing a minimum of 3 minute soakage time prior to wound closure. Two multiple
port catheters will be placed by the surgeon, one directed towards the chest wound and the
other towards the axillary wound. These catheters will then be connected up to the prefilled
INFUSOR single use pump delivering 5 ml/hr of 0.25% bupivacaine.
Postoperatively, all patients will be transferred from theatre to the post anaesthesia care
unit (PACU) where they will remain until PACU discharge criteria are met. In the PACU, if
patients experience pain, 10 ml of 2% Lidocaine will be administered through the catheters in
CWI in the first instance. Morphine 2mg IV PRN may be administered as rescue analgesia if
required thereafter. Patients may be administered additional antiemetics (Ondansetron) in the
PACU.
Following transfer to the ward, all patients will receive a standard analgesic regimen of
Diclofenac sodium, 75 mg PO 12 hourly/ PRN and Paracetamol, 1 g PO/PR, 6 hourly /PRN, and
Oxycodone (Oxynorm) 10mg 4 hourly /PRN.
While in hospital, data in relation to patient recovery, pain and complications will be
recorded using Cork University Hospital's perioperative pathway clinical data sheet.
Following discharge, postoperative data will be collected using a bespoke android app
specifically designed to capture outcome measures on the first and second post operative
days. The app gathers anonymised data in relation to pain (slide-rule page analogous to the
visual analogue score), quality of recovery (QoR40 Score), wound drain output in millilitres
and patient satisfaction on a likert-type scale. Data will be collected following discharge
on the first and second postoperative days. Participants will be encouraged to provide
free-text feedback in relation to their healthcare experience. Any adverse events will be
monitored, recorded and treated appropriately.
Summary data with respect to the primary and secondary endpoints will be presented. Where
appropriate, 95% confidence intervals will be calculated.
