- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02170415
Development of a Personalised Care Plan Designed to Reduce Chronic Post-Operative Pain Following Breast Surgery
Numerous surveys have shown that following breast surgery, longterm pain affects around half of patients. Given that 1 in 9 women will get breast cancer and that surgery is the cornerstone of treatment, persistent pain represents a major challenge. In addition to the suffering chronic pain causes to individual patients, the investigators know that it places a substantial burden on families and carers, and that patients with pain represent an excessive demand on healthcare resources.
This research will evaluate the impact of introducing a proactive, integrated care plan for patients having breast surgery. It will assess the effect of the care plan on reducing the number of patients with pain at 3 and 12 months after their procedure.
The personalised plan involves numerous evidence based steps linked by a single unifying description aimed at controlling pain, before, during and after the procedure, in hospital and at home.
Patients at risk of developing pain will be identified prior to the procedure and randomly allocated to follow either the personalised care plan or to receive 'usual' care. In the personalised care plan group, participants will get information about chronic pain, be screened for pain and offered immediate treatment. During their procedure both the surgeon and the anaesthetist will offer treatments such as nerve numbing procedures that reduce the likelihood of experiencing pain.
After their procedure, patients will be again screened for pain and further treatment instigated. Physiotherapists and other allied health professionals such as psychologists will also be involved as appropriate. A package of care for pain will then be passed on to the patients' GP, in the form of a written pain management plan, for ongoing care which will be linked to the hospital. Patients from both groups will be followed up for a year at regular intervals.
연구 개요
상태
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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London, 영국, SW3 6JJ
- The Royal Marsden Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Women aged 18 and over with breast cancer undergoing breast surgery at the Royal Marsden Hospital. This includes mastectomy, wide local excision with axillary clearance, breast reconstruction surgery i.e Diep flap, LD flap
Exclusion Criteria:
- Previous thoracic surgery.
- Symptomatic angina pectoris.
- Renal impairment.
- Inability to read or to understand consent documentation.
- Patients undergoing the following surgery; lumpectomy, wide local excision, cosmetic procedures, any day-case breast surgery.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Intervention limb
Medical review and analgesic optimisation. Pain education (in the form of leaflet and website recommendations) Psychological input for patients with evidence of psychological morbidity. Protective analgesia - one pre-procedure dose of 150mg oral pregabalin. Five days post-procedure oral pregablin twice daily at a dose of 75mg twice a day. Patients offered a paravertebral block, local anaesthetic infiltrated around the wound by the surgeon. Daily, focused visits from the hospital pain team. Any patient displaying concerning pain symptoms, behaviour or who underwent prolonged (>3 hours surgery) may be booked for early 'preemptive' review in pain clinic. |
Participants in the intervention arm of the study (if no contraindications exist) will be administered one pre-procedure dose of 150mg of oral pregabalin. For a total of five days post-procedure the participants in the intervention limb of the study will take oral pregablin twice daily at a dose of 75mg twice a day.
다른 이름들:
Participant will receive a pain education leaflet
Participants demonstrating psychological morbidity will be offered psychological support prior to surgery
Patients on the intervention limb will be encouraged to have a paravertebral block if not contraindicated
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간섭 없음: Usual care
These partcipants will receive usual care before, during and after their breast surgery
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Difference in pain scores (as indicated by a pain severity index score) in the intervention group compared to the 'usual care' group.
기간: 3 months
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3 months
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2차 결과 측정
결과 측정 |
기간 |
---|---|
The difference in levels of anxiety and depression (versus 'usual care') measured by the hospital anxiety and depression scale (HADS)
기간: 3 and 12 months
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3 and 12 months
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The difference in general health outcomes (versus 'usual care') determined by the EQ5D questionnaire
기간: 3 and 12 months
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3 and 12 months
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The difference in participant satisfaction (versus 'usual care') determined by the Global Surgical Recovery (GSR) Scale.
기간: 3 and 12 months
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3 and 12 months
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: JOHN E WILLIAMS, MB BS FRCA, The Royal Marsden Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- CCR 4116
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