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A pilot study evaluating the effectiveness of a Combined Analgaesic/ Anaesthetic Intervention for the reduction of post-operative pain after breast cancer surgery Justin Wormald MRes Final Year Medical Student Norwich Medical School
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Contents Introduction Objectives Methodology Results Discussion
Conclusions Questions
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30% of cancers in women worldwide 40,500 incident cases 10,900 deaths
Introduction Breast cancer is common 30% of cancers in women worldwide 40,500 incident cases 10,900 deaths WHO. The global burden of disease: 2004 update Office for National Statistics, London. Cancer statistics registrations: registrations of cancer diagnosed in 2005, England Welsh Cancer Intelligence and Surveillance Unit. Cancer incidence in Wales 1992−
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Introduction Breast conserving surgery, wide local excision Mastectomy
Primary treatment is surgery Breast conserving surgery, wide local excision Mastectomy Axillary surgery Breast reconstruction: implant, autologous, immediate, delayed
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Rationale – the NMBRA Severe post-operative pain
Delayed breast reconstruction – 20.1% Immediate breast reconstruction – 16.5% Mastectomy – 6.2% Other major surgery – 11% Pain management for these patients is under investigated and un-standardised Enhanced recovery programmes promoted in literature, including CA/AIs Further investigations of standardised packages of care Jeevan R BJ, Meulen J, Pereira J, Caddy C, Sheppard C, McGregor-Johnson C, Kramer Z, Dean S. The National Mastectomy and Breast Reconstruction Audit – third annual report ;3.
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Objectives Primary Objective Secondary Objective
To investigate the difference in effectiveness between a CA/AI vs routine care on the treatment of acute and chronic post-operative pain after mastectomy and breast reconstruction Secondary Objective To assess the feasibility of a definitive RCT
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Methodology Prospective evaluation of two groups of women undergoing mastectomy with or without reconstruction: CAAI versus routine care Different care at two hospitals JPUH CA/AI NNUH control Questionnaire based: 1 week and 3 months Validated subjective questions that were used in the NMBRA Numerical rating scales We approached women at these two hospitals
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Inclusion criteria Women 18 years or above
Diagnosed with breast cancer or ductal carcinoma in situ (DCIS) Underwent mastectomy or primary breast reconstruction, immediate or delayed
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Intervention Routine Care Standardised
Pre-operative: Paracetamol, ibuprofen, gabapentin Intra-operative: Mastectomy paravertebral block Breast reconstruction thoracic epidural Post-operative: Avoid PCA morphine Paracetamol, ibuprofen, tramadol, oramorph Breast reconstruction epidural run PRN Routine Care Unstandardised, anaesthetist discretion Pre-operative midazolam Intra-operative general anaesthetic Post-operative PCA morphine and paracetamol
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Response rate 67 patients were identified as eligible
41 questionnaires received (58% response rate) 17 from patients at the JPUH, intervention group 24 from patients at the NNUH, control group Response rate: breast reconstruction > mastectomy (47.4% vs. 69.7%)
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Patient Characteristics
CA/AI (n=17) Control arm (n=24) Mean age (years) Mastectomy ± axillary surgery Reconstruction Implant/expander Latissimus dorsi TRAM DIEP Mean pre-operative anxiety
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VRS: Mastectomy ± Axillary Surgery
% 24 hours 1 week
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VRS: Breast Reconstruction
% 24 hours 1 week
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Numerical Rating Scale (NRS)
Score Mastectomy ± Axillary Surgery Breast Reconstruction
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Analysis – Mastectomy ± Axillary Surgery
24 hours Likely to report no/mild pain in intervention group RR 1.6, 95% CI , p=0.03 1 week Lower risk of moderate/severe pain in intervention group RR 0.2, 95% CI , p= 0.06 NRS Consistently lower scores in intervention group Mean differences not significant (p=>0.05)
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Analysis – Breast Reconstruction
24 Hours and 1 week Small, variable differences in RR, not significant (p=>0.05) NRS Consistently lower scores in intervention group Mean differences not significant (p=>0.05)
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Discussion Good opportunity to evaluate different methods of pain management Appears to be beneficial effect of the CA/AI on the reduction of post-operative pain Particularly for mastectomy ± axillary surgery Less effective for breast reconstruction Interpretation limited by: Sample size No randomisation Heterogeneity of breast reconstruction Recall and response bias
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Conclusions Have we achieved our objectives yet?
To investigate the difference in effectiveness between a CA/AI vs. routine care on the reduction of post-operative pain after mastectomy with and without reconstruction To assess the feasibility of a definitive RCT
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Thank you
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