Does Continuous Wound Infusion of 0.2% Bupivacaine Provide Superior Analgesia Compared to Standard Opioid-based Therapy in Patients Following Axillary 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).
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Pain on abducting the arm on the operative side to 90 degrees as measured using a 100mm visual analogue scale at 6 hours following surgery.
6 hours postoperatively
Denise M McCarthy, MB FCARCSI
Cork Universtiy Hospital
Ireland: Research Ethics Committee