Eliminating opioid prescriptions from outpatient minimally invasive gynecologic surgery: a randomized trial.

In a single-blind randomized trial conducted at a tertiary-care academic center, we assessed whether a multimodal opioid-free exit prescription (OFP) for analgesia would result in noninferior postoperative pain control compared to an opioid-containing prescription in patients undergoing MIGS.

在一家三级学术医疗中心进行的单盲随机试验中，我们评估了多模式无阿片类药物出院处方（OFP）用于镇痛是否能在与含阿片类药物处方的患者相比，达到非劣效的术后疼痛控制效果。

Female patients without prior pain conditions undergoing outpatient laparoscopic MIGS were randomized to receive either an OFP or a restrictive opioid prescription (ROP; five tablets hydromorphone 1 mg) alongside multimodal analgesia.

没有先前疼痛病史的女性患者在门诊接受腹腔镜微创妇科手术（MIGS）时，被随机分配接受开放性疼痛管理（OFP）或限制性阿片类药物处方（ROP；五片氢吗啡酮1毫克），同时接受多模式镇痛治疗。

The primary outcome was patient-reported pain on postoperative day (POD) 1.

主要结果是术后第1天（POD 1）患者自报的疼痛情况。

Secondary outcomes included patient-reported pain and measures of recovery such as total opioid consumption, participant mobility, opioid-related side effects, return to emergency room or clinic, need for rescue analgesia prescription, overall satisfaction with pain control and overall satisfaction with postoperative care, which were assessed on POD1 and POD7 by a blinded outcome assessor.

次要结果包括患者报告的疼痛和恢复措施，如总阿片类药物消耗量、参与者活动能力、阿片类药物相关副作用、返回急诊室或诊所、需要急救镇痛处方、对疼痛控制的整体满意度以及对手术后护理的整体满意度，这些在术后第1天（POD1）和术后第7天（POD7）由一名盲法结果评估者进行评估。

Of n = 110 patients randomized, n = 103 completed the study (OFP = 49, ROP = 54).

在随机分配的 n = 110 名患者中，n = 103 完成了研究（OFP = 49，ROP = 54）。

No significant difference in mean pain scores on POD1 (3.1 versus 3.5, P = 0.31) or POD7 (1.0 versus 1.5, P = 0.14) were found.

在术后第1天（POD1）平均疼痛评分（3.1对比3.5，P=0.31）或术后第7天（POD7）（1.0对比1.5，P=0.14）未发现显著差异。

Mobility and satisfaction were comparable.

移动能力和满意度相当。

ROP patients experienced more nausea and vomiting (14.3% versus 35.2%, P = 0.01).

ROP患者经历了更多的恶心和呕吐（14.3%对比35.2%，P = 0.01）。

No OFP patients required rescue opioids.

没有OFP患者需要急救性阿片类药物。

Only 27.8% and 11.1% of ROP patients consumed opioids by POD1 and POD7 respectively.

只有27.8%和11.1%的ROP患者在术后第1天和第7天分别使用了阿片类药物。

Thus, in patients undergoing outpatient MIGS, an OFP resulted in noninferior postoperative pain compared to an ROP, suggesting that opioids may be safely omitted in this clinical context.

因此，在接受门诊MIGS手术的患者中，OFP在术后疼痛控制方面与ROP相当，这表明在这种临床情况下可以安全地省略阿片类药物。

ClinicalTrials.gov identifier: NCT04837014 .

ClinicalTrials.gov注册号：NCT04837014。