Title: Is intra- operative passive movement therapy (IPM) effective in reducing post- operative morphine consumption, and improving the quality of recovery and functional ability of patients following breast reconstruction surgery? A randomised controlled trial.
Funder: Department of Health (England)

Abstract: Background- Immobility and positioning during breast reconstruction may lead to NSSP and stiffness in the post-operative period. Despite implementation of positioning recommendations3, local audit revealed 62% of women undergoing breast reconstruction suffered NSSP post-operatively4, in some cases worse than the surgical site. This surgery requires patients to lie immobilised for 7-12 hours with arms outstretched, and is carried out on about 1,500 women across the UK each year. In the absence of any existing intervention, IPM therapy was developed to counter immobility and positioning effects. A preliminary study suggested that the proposed design is feasible6 and IPM is likely to have patient benefit. Aim- To evaluate the effectiveness of IPM therapy in reducing morphine consumption, and improving quality of recovery and function in the post-operative period for breast reconstruction patients- using a parallel-arm RCT design. Outcomes and sample size- The primary outcome (upon which the study is powered) is '3 day post-operative morphine consumption'- 142 women will be recruited to evaluate a 30% difference in morphine consumption between study arms based on 15% attrition rate (a difference of 30% is considered clinically significant7) . This was chosen as the primary outcome with a patient focus group who disliked the side-effects of morphine. Secondary outcomes are:- Quality of recovery using the QoR- 40 8,9,10, holding a cup to drink and hair brushing, chosen with the focus group. Intervention- IPM therapy6, has been developed by the study team and trialled successfully in a feasibility study. It is tailored specifically to counteract the specific NSSP and stiffness suffered by this patient group. Methods- Patients scheduled to undergo a free-flap breast reconstruction will be given a participant information sheet at their outpatient appointment 3 weeks before surgery. They will have the opportunity to ask questions then, by telephone and upon admission the day before surgery. The research nurse will then gain written consent if they wish to participate and will also collect pre-operative data on baseline function of the upper limb. Participants will be allocated to the 'IPM' group using a computer generated randomisation list. The anaesthetist will be blinded to the allocation of the treatment and will follow a standardised anaesthetic and analgesic regime for this study. During surgery, when the free-flap is raised, the ODP will open a randomisation envelope and if allocated conduct IPM then and at the end of surgery. At both these time points, the anaesthetist will leave theatre, but remain in the adjoining room for 5 minutes to maintain blinding. The research nurse collecting data will be blinded to the study groups. Data will be entered into a dedicated secure database by the research nurse and analysed by the statistician using Student's Independent T-test or Mann-Whitney U depending on data normality. Confounding variables will be analysed (age, weight, duration of surgery, systemic illness, intra-operative morphine) and adjustments made as necessary. This intervention is designed to be administered by ODPs already present in theatre and a stand-alone training DVD is already produced- implementation costs are negligible. Feasibility study data indicates a clinically significant reduction in post-operative morphine consumption is likely- benefitting patients by reducing side-effects (drowsiness, nausea, itching and constipation) and potentially improving their recovery experience. Furthermore the study has the potential to benefit the NHS by improving the patient experience and reducing the burden of morphine and its side-effect in this patient group. In future IPM may be adapted for other lengthy operations such as neurosurgery or maxillofacial cancer surgery.


Research activity codes: 6.7 PHYSICAL
Health categories: CANCER AND NEOPLASMS