1. 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

2. Contents Introduction Objectives Methodology Results Discussion
Conclusions
Questions

3. 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−

4. 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

5. 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.

6. 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

7. 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

8. 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

9. 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

10. 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%)

11. 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

12. VRS: Mastectomy ± Axillary Surgery%
24 hours
1 week

13. VRS: Breast Reconstruction%
24 hours
1 week

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

15. 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)

16. 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)

17. 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

18. 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

19. Thank you