Inclusion criteria were all patients who were undergoing significant hind foot or ankle procedures. Exclusion criteria included coexisting peripheral neuropathy and any inability to fill in the questionnaire. The pilot study provided a standard deviation of pain scores which allowed us to calculate the sample size required; 25 patients in each group would have 90% power to detect a difference in means VAS scores of 3 which we considered to be clinically significant. A total number of 56 (to allow for 10% loss to follow-up) were recruited. The patients and the assessors were blinded to the treatment allocated. Sealed envelopes contained random allocations and were opened by the anaesthetist. A bolus of 20ml 0.25% bupivacaine was injected and then the catheter was inserted and connected to a pump. Patients were randomly assigned to receive either an infusion of normal saline or bupivacaine over the next 72 hours. The patients were asked to complete a visual analogue pain chart, three times daily, for 72 hours postoperatively. Data was also recorded regarding supplementary opiate analgesic requirements and any problems or complications. Statistical analysis was performed using MedCalc for Windows, version 9.6.4 (MedCalc software, Mariakerke, Belgium). A Mann-Whitney U test was used for the non-parametric data sets.
There was no difference in median milligrams of morphine usage on the day of operation; study = 10, placebo = 10 (p = 0.942). The morphine usage was lower in the study group on all post operative days and this was significant on days 2&
3; day 1: 10 v’s 15 (p=0.054), day 2: 10 v’s 20 (p=<
0.001), day 3: 7.5 v’s 10 (p=0.02). Median total morphine requirements over the 3 post operative days were 30mg for the study group compared to 52.5mg for the control group and this was significant (p=0.012). The study group on average spent less nights as an inpatient with a median value of 1 compared to 2 for the control but this was not significant (p=0.430). There were no major complications with the administration of the blocks or with the catheters.