BACKGROUND: Postmastectomy pain syndrome is a common and disabling side effect of breast cancer treatment. Medical treatment seems to be insufficient for a considerable proportion of patients. Fat grafting has shown promise in relieving pain from postmastectomy pain syndrome, but no randomized clinical trial comparing fat grafting to a sham operation has been performed to date. The authors' objective was to compare the effect of fat grafting compared to a sham operation for treating postmastectomy pain syndrome. METHODS: The authors conducted a single-center, double-blind, randomized clinical trial with two arms between October of 2017 and September of 2020. The authors assessed four patients suffering from postmastectomy pain syndrome for inclusion. The intervention group received scar-releasing rigottomy and fat grafting to the area of pain. The control group received scar-releasing rigottomy and a placebo of saline solution. The primary outcome was the degree of pain measured using the Numerical Rating Scale. The secondary outcomes were the degree and quality of neuropathic pain (Neuropathic Pain Symptom Inventory) and quality of life (36-Item Short-Form Health Survey). Follow-up was 6 months. RESULTS: Thirty-five participants completed follow-up: 18 participants in the intervention group and 17 in the control group. The authors detected no statistically significant changes in average and maximum pain or neuropathic pain. Regarding quality of life, the control group reported a statistically significant improvement in emotional problem parameters, whereas the intervention group reported a deterioration. The authors observed no serious adverse effects. CONCLUSION: The authors did not find evidence to support that fat grafting is superior to a placebo when treating postmastectomy pain syndrome. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.
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