Preoperative single-dose systemic steroid in major head and neck surgery (J-SUPPORT 2002, PreSte-HN Study): a phase III, placebo-controlled, randomized, double-blind study.

BACKGROUND

Enhanced Recovery After Surgery programs have been adopted for head and neck cancer surgery with free tissue transfer reconstruction, but postoperative recovery remains difficult because of the high invasiveness of this procedure. Corticosteroids administered before surgery reduce pain, nausea, and systemic inflammation in other surgical settings, but their benefit in this context is uncertain.

METHODS

This phase III, multicenter, randomized, double-blind, placebo-controlled trial was conducted at three tertiary cancer centers in Japan. A total of 180 adults undergoing head and neck cancer surgery with free tissue transfer reconstruction were randomly assigned to receive a single intravenous dose of 8 mg dexamethasone phosphate or placebo before surgery. The primary outcome was postoperative quality of recovery, assessed by total scores on the Japanese version of the Quality of Recovery questionnaire on postoperative days 2 and 4. Secondary outcomes included postoperative pain, nausea, systemic inflammatory markers, postoperative complications, and length of hospital stay.

RESULTS

Among 178 evaluable patients, postoperative quality of recovery did not differ significantly between the dexamethasone and placebo groups. No significant differences were observed in postoperative pain or nausea. Dexamethasone significantly reduced postoperative serum interleukin-6 and C-reactive protein levels but did not improve patient-reported recovery or shorten hospitalization. Overall postoperative complication rates were similar between the groups.

CONCLUSIONS

Preoperative dexamethasone reduced systemic inflammation but did not improve postoperative recovery, pain, or nausea after head and neck cancer surgery with free tissue transfer reconstruction. Inflammation control alone may be insufficient to enhance recovery after highly invasive surgery.