Breast Cancer Clinical Trial
Official title:
Does Continuous Wound Infusion of 0.2% Bupivacaine Provide Superior Analgesia Compared to Standard Opioid-based Therapy in Patients Following Axillary Clearance Surgery?
Axillary clearance forms part of the surgical armamentarium for the treatment of breast
cancer. Although the introduction of sentinel lymph node mapping and dissection has allowed
for the decreased use of axillary clearance, it remains a frequently performed operation.
Axillary clearance is associated with moderate postoperative pain.
We hypothesize that a continuous wound infusion of 0.2% Bupivacaine at 4ml/hr would provide
superior analgesia, when compared to standard opioid-based analgesia, in patients undergoing
axillary lymph node clearance surgery.
The study will take the form of a prospective randomised clinical trial. The following
assessment tools will be used
- The visual analogue scale (VAS) consists of a 100 mm horizontal line with the two end
points labelled "no pain" and "worst pain ever". Patients are asked to mark on the line
a point that corresponds to the level of pain intensity they feel. The score is
obtained by measuring the distance (mm) from the left end of the line.
- The short-form McGill Pain Questionnaire (SF-MPQ) consists of 15 representative words
from the sensory and affective categories of the standard McGill Pain Questionnaire. It
also includes the present pain intensity and a VAS to provide overall indices of pain
intensity. It has been shown to be sensitive to clinical changes brought about by
various interventions, postoperative analgesic drugs (6).
- The Pain Catastrophising Score (PCS) is a 13 item instrument which asks patient to
reflect on past painful experiences, and to indicate the degree to which they
experienced each of these 13 thoughts or feelings, on 5-point scales with the end
points; 0 = not at all, 4 = all the time. The PCS yields a total score and three
subscale scores assessing rumination, magnification and helplessness (7).
- The Hospital Anxiety and Depression Score (HADS) is a 14-item scale, which screens for
these, the two most common disturbances encountered in a medical setting (8).
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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