Results
During the study period, 129 patients met the inclusion criteria. Of
these, five patients declined to participate, and additional four
patients were excluded due to technical reasons (none of the
investigating surgeons was available). After enrollment, one patient was
found to have malignancy during the operation. Ultimately, 119 patients
(group 1- 30, group 2- 30, group 3- 29, group 4- 30) completed full pain
assessment (Figure 1). All patients returned for a follow up visit. No
early / late complications or adverse effects were registered for the
study population. No malignancy was detected on final pathological
examination (for the patient who
completed enrollment and were included in the final analysis).
We did not detect any differences
between the study groups and the patient and surgery characteristics
(Table 1). Also, there was no difference in the frequency of major vs.
minor surgeries between the study groups (P-value=0.34, Tables S1 A and
B).
No
significant associations were found between the study groups and the
discrete and total VAS scores in
3, 8 and 24 hours after surgery, in either univariate and multivariate
analyses (Table 2, Figure 2, and
Table S2).
No significant association was found between the study groups and the
MME given during recovery, and the Analgesic index (Table S2). Only 6
patients were treated with opioids 3 hours post-surgery (there was no
difference between the groups). None needed such treatment at and 8 and
24 hours post-surgery. Furthermore,
we did not detect differences in
the risk for pain that required analgesic treatment in both univariate
and multivariate analyses.
When comparing patients who were treated with and without subcutaneous
anesthesia and patients with and without intra-peritoneal anesthesia, we
did not detect differences in both pain assessment and analgesic
prescription outcomes (Table S3).