PDF(Pubmed)
Abstract：
UNASSIGNED: Cannabidiol (CBD) has been shown recently to positively affect patient pain and satisfaction immediately after arthroscopic rotator cuff repair (ARCR). However, it is unclear whether the addition of CBD to a perioperative regimen could affect postoperative outcomes.
UNASSIGNED: To evaluate patient-reported outcomes among patients who underwent ARCR and received buccally absorbed CBD or an identical placebo for early postoperative pain management at 1-year follow-up.
UNASSIGNED: Randomized controlled trial; Level of evidence, 2.
UNASSIGNED: Eligible patients had previously participated in a multicenter, placebo-controlled, randomized, double-blinded trial that evaluated the analgesic effects of CBD in the immediate postoperative period after ARCR. The experimental group received 25 mg of CBD 3 times/day if <80 kg and 50 mg of CBD 3 times/day if >80 kg for 14 days, with the control group receiving an identical placebo. The following outcomes were assessed at minimum 1-year follow-up: visual analog scale (VAS) for pain, American Shoulder and Elbow Surgeons (ASES) score, Single Assessment Numeric Evaluation (SANE), and patient satisfaction. The rates of achievement of the Patient Acceptable Symptom State (PASS) were compared based on ASES at latest follow-up. Continuous and categorical variables were compared with the Mann-Whitney U test and Fisher exact test, respectively.
UNASSIGNED: Follow-up was obtained from 83 of 99 patients (83.8%) who completed the original trial. There were no significant differences between the CBD and control groups with respect to age, sex, body mass index, rate of concomitant procedures, or number of anchors used intraoperatively. At 1-year follow-up, there were no significant differences between the CBD and control groups in VAS pain (0.8 vs 1.2, P = .38), ASES (93.0 vs 91.1, P = .71), SANE (87.6 vs 90.1, P = .24), or satisfaction (97.4 vs 95.4, P = .41). A majority of patients achieved the PASS (81.0% [CBD] vs 77.5% [control]; P = .79).
UNASSIGNED: Perioperative use of CBD for pain control among patients undergoing ARCR did not result in any significant deficits in pain, satisfaction, or patient-reported outcomes at 1-year postoperatively compared with a placebo control group. These findings suggest that CBD can be considered in a postoperative multimodal pain management regimen without detrimental effects on outcome.
UNASSIGNED: NCT04672252 (ClinicalTrials.gov identifier).
UNASSIGNED: To evaluate patient-reported outcomes among patients who underwent ARCR and received buccally absorbed CBD or an identical placebo for early postoperative pain management at 1-year follow-up.
UNASSIGNED: Randomized controlled trial; Level of evidence, 2.
UNASSIGNED: Eligible patients had previously participated in a multicenter, placebo-controlled, randomized, double-blinded trial that evaluated the analgesic effects of CBD in the immediate postoperative period after ARCR. The experimental group received 25 mg of CBD 3 times/day if <80 kg and 50 mg of CBD 3 times/day if >80 kg for 14 days, with the control group receiving an identical placebo. The following outcomes were assessed at minimum 1-year follow-up: visual analog scale (VAS) for pain, American Shoulder and Elbow Surgeons (ASES) score, Single Assessment Numeric Evaluation (SANE), and patient satisfaction. The rates of achievement of the Patient Acceptable Symptom State (PASS) were compared based on ASES at latest follow-up. Continuous and categorical variables were compared with the Mann-Whitney U test and Fisher exact test, respectively.
UNASSIGNED: Follow-up was obtained from 83 of 99 patients (83.8%) who completed the original trial. There were no significant differences between the CBD and control groups with respect to age, sex, body mass index, rate of concomitant procedures, or number of anchors used intraoperatively. At 1-year follow-up, there were no significant differences between the CBD and control groups in VAS pain (0.8 vs 1.2, P = .38), ASES (93.0 vs 91.1, P = .71), SANE (87.6 vs 90.1, P = .24), or satisfaction (97.4 vs 95.4, P = .41). A majority of patients achieved the PASS (81.0% [CBD] vs 77.5% [control]; P = .79).
UNASSIGNED: Perioperative use of CBD for pain control among patients undergoing ARCR did not result in any significant deficits in pain, satisfaction, or patient-reported outcomes at 1-year postoperatively compared with a placebo control group. These findings suggest that CBD can be considered in a postoperative multimodal pain management regimen without detrimental effects on outcome.
UNASSIGNED: NCT04672252 (ClinicalTrials.gov identifier).
摘要：
■最近已显示大麻二酚（CBD）在关节镜肩袖修复（ARCR）后立即对患者疼痛和满意度产生积极影响。然而,目前尚不清楚围手术期方案中加入CBD是否会影响术后结局.
■评估接受ARCR并接受口腔吸收CBD或相同安慰剂治疗的患者在1年随访后早期疼痛管理的患者报告结果。
■随机对照试验；证据水平，2.
■符合条件的患者以前参加过多中心，安慰剂对照,随机化，评估CBD在ARCR术后即刻镇痛效果的双盲试验。如果<80kg，则实验组接受25mgCBD3次/天，如果>80kg，则接受50mgCBD3次/天，持续14天，对照组接受相同的安慰剂。在至少1年的随访中评估以下结果：疼痛的视觉模拟量表（VAS），美国肩肘外科医师（ASES）评分，单一评估数字评估(SANE)，患者满意度。在最近的随访中，根据ASES比较了患者可接受症状状态（PASS）的实现率。连续变量和分类变量进行了比较，采用Mann-WhitneyU检验和Fisher精确检验，分别。
■从完成原始试验的99名患者中的83名（83.8％）获得了随访。CBD和对照组在年龄方面没有显着差异，性别,身体质量指数,伴随程序的比率，或术中使用的锚钉数量。在1年的随访中，CBD和对照组在VAS疼痛方面没有显着差异（0.8vs1.2，P=.38），ASES（93.0vs91.1，P=.71），SANE（87.6vs90.1，P=.24），或满意度（97.4vs95.4，P=.41）。大多数患者达到了PASS（81.0%[CBD]vs77.5%[对照]；P=0.79）。
■在接受ARCR的患者中，围手术期使用CBD进行疼痛控制并未导致任何明显的疼痛缺陷，满意,或术后1年患者报告的结局与安慰剂对照组比较.这些发现表明，可以在术后多模式疼痛管理方案中考虑CBD，而不会对结果产生不利影响。
■NCT04672252（ClinicalTrials.gov标识符）。
■评估接受ARCR并接受口腔吸收CBD或相同安慰剂治疗的患者在1年随访后早期疼痛管理的患者报告结果。
■随机对照试验；证据水平，2.
■符合条件的患者以前参加过多中心，安慰剂对照,随机化，评估CBD在ARCR术后即刻镇痛效果的双盲试验。如果<80kg，则实验组接受25mgCBD3次/天，如果>80kg，则接受50mgCBD3次/天，持续14天，对照组接受相同的安慰剂。在至少1年的随访中评估以下结果：疼痛的视觉模拟量表（VAS），美国肩肘外科医师（ASES）评分，单一评估数字评估(SANE)，患者满意度。在最近的随访中，根据ASES比较了患者可接受症状状态（PASS）的实现率。连续变量和分类变量进行了比较，采用Mann-WhitneyU检验和Fisher精确检验，分别。
■从完成原始试验的99名患者中的83名（83.8％）获得了随访。CBD和对照组在年龄方面没有显着差异，性别,身体质量指数,伴随程序的比率，或术中使用的锚钉数量。在1年的随访中，CBD和对照组在VAS疼痛方面没有显着差异（0.8vs1.2，P=.38），ASES（93.0vs91.1，P=.71），SANE（87.6vs90.1，P=.24），或满意度（97.4vs95.4，P=.41）。大多数患者达到了PASS（81.0%[CBD]vs77.5%[对照]；P=0.79）。
■在接受ARCR的患者中，围手术期使用CBD进行疼痛控制并未导致任何明显的疼痛缺陷，满意,或术后1年患者报告的结局与安慰剂对照组比较.这些发现表明，可以在术后多模式疼痛管理方案中考虑CBD，而不会对结果产生不利影响。
■NCT04672252（ClinicalTrials.gov标识符）。
