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临床试验/NCT02897934
NCT02897934已完成不适用

Continuous Wound Infiltration and 23 Hour Discharge Following Major Breast Cancer Surgery

University College Cork1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2016年8月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Pain

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Women undergoing any one of:
  • mastectomy mastectomy with axillary lymph node clearance mastectomy with axillary lymph node sampling

排除标准

  • Refusal to participate; Allergy to Bupivacaine; Pre-existing pain conditions; Regular use of opioid analgesia; Pregnancy; Uncontrolled Diabetes; Uncontrolled Thyroid disorder; Severe cardiac, renal or hepatic disease ; Bilateral surgery; Planned discharge >23 hours; Travel time from the admitting hospital >45 minutes; Absence of intellectual capacity to consent

结局指标

主要结局

Pain

时间窗: 24 hours, 48 hours

Pain will be recorded at at 24 and 48 hours using a slide-rule page on bespoke Android App. Pain will be recorded in a manner analogous to a visual analog scale 0 = No pain, 100 = Worst imaginable pain. Participants will be prompted on the first and second postoperative days to score their worst level of pain.

次要结局

  • Quality of recovery at 24 & 48 hours (QoR 40)(24 hours, 48 hours)
  • Analgesic Consumption at 24 & 48 hours(24 hours, 48 hours)
  • Wound drain output at 24 & 48 hours(24 hours, 48 hours)
  • patient satisfaction(48 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brian Declan O'Donnell

Consultant Anaesthetist and Clinical Senior Lecturer

University College Cork

研究点 (1)

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