Caesarean -Section Study Summary
A total of 94 subjects were equally randomized into the active and placebo treatment groups in this double blind study. The primary measures were daily pain levels and medication use. In hospital pain scores were found to be equivalent across the two groups and averaged about 3.5 VAS points due to the hospital’s medication protocol of keeping pain levels low. However, upon arriving home, pain levels in the placebo group increased significantly, with the average pain score about 2 VAS points higher than when they were in the hospital. While pain levels in the treatment group also increased upon arriving home, the average increase was significantly lower when compared to the placebo group.
These results are shown graphically in Figure 1.
Figure 1: While the PM VAS scores for both groups increased when compared to the last hospital score, the increase was lower in the active treatment group by 0.74 points.
A second analysis looked at the proportion of subjects who reported only mild pain (VAS<=3) during their total stay in the hospital and the proportion who reported mild pain for any given day (i.e., both AM and PM) during home recovery. During hospital stay, 27% in the active group and 10.8% in the placebo group reported a mild pain score for each of the pain scores recorded. This difference was significant at the p<0.05 level. The same analysis was conducted on data for subjects reporting mild VAS pain in the 5 days and is shown in Figure 2.
Figure 2: Percent reporting mild pain (VAS <=3) on both AM and PM VAS scores, during at-home period of postoperative recovery. A test for differences between two independent sample proportions indicates that the proportion of patients reporting “mild pain” differ significantly between active and placebo groups and days 1, 2 and 3, but not 4 and 5.
Medication use during hospital stay and home recovery periods was lower in the active treatment group when compared to the placebo group, but these differences were not statistically significant.