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

Contents Introduction Objectives Methodology Results Discussion Conclusions Questions

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. 2008. Office for National Statistics, London. Cancer statistics registrations: registrations of cancer diagnosed in 2005, England. 2008. Welsh Cancer Intelligence and Surveillance Unit. Cancer incidence in Wales 1992−2002. 2008.

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

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 2010. 2010;3.

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

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

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

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

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%)

Patient Characteristics CA/AI (n=17) Control arm (n=24) Mean age (years) 58 57 Mastectomy ± axillary surgery 10 8 Reconstruction 7 16 Implant/expander 2 3 Latissimus dorsi 4 1 TRAM 1 0 DIEP 0 12 Mean pre-operative anxiety 5.19 4.29

VRS: Mastectomy ± Axillary Surgery % 24 hours 1 week

VRS: Breast Reconstruction % 24 hours 1 week

Numerical Rating Scale (NRS) Score Mastectomy ± Axillary Surgery Breast Reconstruction

Analysis – Mastectomy ± Axillary Surgery 24 hours Likely to report no/mild pain in intervention group RR 1.6, 95% CI 0.94-2.73, p=0.03 1 week Lower risk of moderate/severe pain in intervention group RR 0.2, 95% CI 0.03-1.46, p= 0.06 NRS Consistently lower scores in intervention group Mean differences not significant (p=>0.05)

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)

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

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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