OrthoCarolina Spine Center.
Atrium Health Musculoskeletal Institute.
Clin Spine Surg. 2024 May 1;37(4):138-148. doi: 10.1097/BSD.0000000000001608. Epub 2024 Mar 28.
Randomized controlled trial (RCT).
Compare the efficacy of a multimodal, opioid-free (OF) pain management pathway with a traditional opioid-containing (OC) pathway in patients undergoing anterior cervical procedures.
Previous studies have compared opioid-based pain regimens to opioid-sparing regimens following cervical spine surgery, but have been limited by high rates of crossover, retrospective designs, reliance on indwelling pain catheters, opioid utilization for early postoperative analgesia, and/or a lack of patient-reported outcome measures.
This is a RCT in which patients were allocated to either an OF or OC perioperative pain management protocol. Eligible study participants included adult (age up to 18 y) patients who underwent primary, 1-level or 2-level anterior cervical surgery [anterior cervical discectomy and fusion (ACDF), anterior cervical disc arthroplasty (ACDA), or hybrid (ACDF and ACDA at different levels)] for degenerative pathology. The primary outcome variable was subjective pain level at 24 hours postoperative. The final study cohort consisted of 50 patients (22 OF, 28 OC).
Patients in the OF group reported lower median postoperative pain levels at 6 hours (4 for OF vs. 7 for OC; P =0.041) and 24 hours (3 for OF vs. 5 for OC; P =0.032). At 2-week and 6-week follow-up, pain levels were similar between groups. Patients in the OF group reported greater comfort at 12 hours (9 for OF vs. 5 for OC; P =0.003) and 24 hours (9 for OF vs. 5 for OC; P =0.011) postoperatively. Notably, there were no significant differences in patients' reported pain satisfaction, overall surgical satisfaction, or overall sense of physical and mental well-being. In addition, there were no significant differences in falls, delirium, or constipation postoperatively.
A multimodal OF pain management pathway following anterior cervical surgery for degenerative disease results in statistically noninferior pain control and equivalent patient-reported outcome measures compared with a traditional OC pathway.
随机对照试验（RCT）。
比较多模式、无阿片（OF）疼痛管理路径与传统含阿片（OC）路径在接受前路颈椎手术患者中的疗效。
先前的研究比较了颈椎手术后基于阿片类药物的疼痛方案与阿片类药物节约方案，但受到高交叉率、回顾性设计、对留置疼痛导管的依赖、术后早期使用阿片类药物进行镇痛、以及/或缺乏患者报告的结果测量等因素的限制。
这是一项 RCT，患者被分配到 OF 或 OC 围手术期疼痛管理方案中。符合条件的研究参与者包括接受原发性、1 级或 2 级前路颈椎手术（前路颈椎间盘切除术和融合术 [ACDF]、前路颈椎间盘置换术 [ACDA] 或前路颈椎融合术和前路颈椎间盘置换术 [在不同水平]）的成年（年龄不超过 18 岁）患者，用于退行性病变。主要结局变量是术后 24 小时的主观疼痛水平。最终研究队列包括 50 名患者（22 名 OF，28 名 OC）。
OF 组患者在术后 6 小时（4 分 OF 比 7 分 OC；P =0.041）和 24 小时（3 分 OF 比 5 分 OC；P =0.032）时报告的中位数术后疼痛水平较低。在 2 周和 6 周随访时，两组的疼痛水平相似。OF 组患者在 12 小时（9 分 OF 比 5 分 OC；P =0.003）和 24 小时（9 分 OF 比 5 分 OC；P =0.011）时报告的舒适度更高。值得注意的是，患者报告的疼痛满意度、整体手术满意度或整体身体和精神健康状况无显著差异。此外，术后无明显差异在跌倒、谵妄或便秘方面。
对于退行性疾病行前路颈椎手术后，多模式 OF 疼痛管理路径可实现统计学上非劣效的疼痛控制，并与传统 OC 路径获得等效的患者报告结局。
