Abstract：
Patients undergoing vaginal hysterectomy with native tissue pelvic reconstruction typically have low pain levels overall in the postoperative period. Notwithstanding, pain control immediately after surgery may be more challenging and a barrier to same-day discharge. Intrarectal diazepam has been used for acute and chronic pelvic pain and has a pharmacokinetic profile ideal for intermittent use. However, its use has not been investigated after the surgical intervention.
This study aimed to evaluate the effect of diazepam rectal suppositories on early postoperative pain after hysterectomy and vaginal reconstruction for pelvic organ prolapse.
This was a double-blind, randomized, placebo-controlled trial comparing postoperative pain scores after vaginal hysterectomy with native tissue prolapse repairs. Patients were randomized to receive either an intrarectal 10-mg diazepam suppository or an identical placebo. Moreover, the participants completed the questionnaires at baseline, the morning of postoperative day 1, and 2 weeks after the operation. Surveys included visual analog scales for pain, a validated Surgical Satisfaction Questionnaire, and queries regarding medication side effects and postoperative recovery. The primary outcome was pain scores based on a visual analog scale approximately 3 hours after surgery. The secondary outcomes included total morphine equivalents after surgery, patient satisfaction with pain control, same-day discharge outcome, and overall satisfaction. The chi-square, Fisher exact, and Mann-Whitney tests were used. Based on a 10-mm difference in postoperative vaginal pain using the visual analog scale, sample size was calculated to be 55 patients in each arm to achieve 80% power with an alpha of.05.
From February 2020 to August 2021, 130 participants were randomized. Of those participants, 7 withdrew, and 123 were analyzed: 60 in the diazepam group and 63 in the placebo group. The median age was 65 years (interquartile range, 27-80), the median body mass index was 27.9 kg/m2 (interquartile range, 18.70-45.90), and 119 of 123 participants (96.7%) were White. There was no difference in the baseline characteristics, prolapse stage, or types of procedures performed between groups. Most participants had concurrent uterosacral ligament suspension with anterior and posterior repairs. Of note, 50 of 123 participants (41%) had midurethral slings. Moreover, 61 of 123 participants (50%) were discharged on the day of surgery. There was no difference in the primary outcome of vaginal pain 3.5 to 6.0 hours postoperatively (25 vs 21 mm; P=.285). In addition, the amount of rescue narcotics used in the immediate postoperative period (19.0 vs 17.0 MME; P=.202) did not differ between groups. At 2-weeks postoperatively, patients in the placebo group reported higher satisfaction with pain control in the hospital (31 vs 43 mm; P=.006) and pain control at home (31 vs 42 mm; P=.022). No difference was noted between same-day discharges and those who were admitted overnight.
The placement of a 10-mg diazepam rectal suppository immediately after pelvic reconstructive surgery did not improve pain or narcotic usage in the early postoperative period. Although the placebo group reported slightly higher satisfaction with pain control 2 weeks after surgery, overall pain levels were low. Therefore, we do not believe that the addition of diazepam to the postoperative regimen is warranted.
This study aimed to evaluate the effect of diazepam rectal suppositories on early postoperative pain after hysterectomy and vaginal reconstruction for pelvic organ prolapse.
This was a double-blind, randomized, placebo-controlled trial comparing postoperative pain scores after vaginal hysterectomy with native tissue prolapse repairs. Patients were randomized to receive either an intrarectal 10-mg diazepam suppository or an identical placebo. Moreover, the participants completed the questionnaires at baseline, the morning of postoperative day 1, and 2 weeks after the operation. Surveys included visual analog scales for pain, a validated Surgical Satisfaction Questionnaire, and queries regarding medication side effects and postoperative recovery. The primary outcome was pain scores based on a visual analog scale approximately 3 hours after surgery. The secondary outcomes included total morphine equivalents after surgery, patient satisfaction with pain control, same-day discharge outcome, and overall satisfaction. The chi-square, Fisher exact, and Mann-Whitney tests were used. Based on a 10-mm difference in postoperative vaginal pain using the visual analog scale, sample size was calculated to be 55 patients in each arm to achieve 80% power with an alpha of.05.
From February 2020 to August 2021, 130 participants were randomized. Of those participants, 7 withdrew, and 123 were analyzed: 60 in the diazepam group and 63 in the placebo group. The median age was 65 years (interquartile range, 27-80), the median body mass index was 27.9 kg/m2 (interquartile range, 18.70-45.90), and 119 of 123 participants (96.7%) were White. There was no difference in the baseline characteristics, prolapse stage, or types of procedures performed between groups. Most participants had concurrent uterosacral ligament suspension with anterior and posterior repairs. Of note, 50 of 123 participants (41%) had midurethral slings. Moreover, 61 of 123 participants (50%) were discharged on the day of surgery. There was no difference in the primary outcome of vaginal pain 3.5 to 6.0 hours postoperatively (25 vs 21 mm; P=.285). In addition, the amount of rescue narcotics used in the immediate postoperative period (19.0 vs 17.0 MME; P=.202) did not differ between groups. At 2-weeks postoperatively, patients in the placebo group reported higher satisfaction with pain control in the hospital (31 vs 43 mm; P=.006) and pain control at home (31 vs 42 mm; P=.022). No difference was noted between same-day discharges and those who were admitted overnight.
The placement of a 10-mg diazepam rectal suppository immediately after pelvic reconstructive surgery did not improve pain or narcotic usage in the early postoperative period. Although the placebo group reported slightly higher satisfaction with pain control 2 weeks after surgery, overall pain levels were low. Therefore, we do not believe that the addition of diazepam to the postoperative regimen is warranted.
摘要：
接受阴式子宫切除术和天然组织骨盆重建的患者通常在术后期间总体疼痛水平较低。尽管如此,手术后立即控制疼痛可能更具挑战性,也是当天出院的障碍.直肠内地西泮已用于急性和慢性盆腔疼痛，并具有理想的间歇性使用的药代动力学特征。然而,手术干预后尚未对其使用进行调查。
本研究旨在评估地西泮直肠栓剂对盆腔器官脱垂子宫切除术和阴道重建术后早期疼痛的影响。
这是双盲,随机化，安慰剂对照试验比较阴式子宫切除术与天然组织脱垂修复术后疼痛评分.患者被随机分配接受直肠内10mg地西泮栓剂或相同的安慰剂。此外，参与者在基线时完成了问卷，术后第1天上午和术后2周。调查包括疼痛的视觉模拟量表，经过验证的手术满意度问卷，以及有关药物副作用和术后恢复的询问。主要结果是手术后约3小时基于视觉模拟量表的疼痛评分。次要结果包括手术后的总吗啡当量，患者对疼痛控制的满意度，当天出院结果，和总体满意度。卡方，费希尔确切,并且使用了Mann-Whitney测试。基于使用视觉模拟量表在术后阴道疼痛中10毫米的差异，样本量计算为每只手臂55名患者，以达到80%的功率，α为0.05。
从2020年2月到2021年8月，130名参与者被随机分配。在这些参与者中，7退出，分析了123例：地西泮组60例，安慰剂组63例。中位年龄为65岁(四分位距，27-80),中位体重指数为27.9kg/m2(四分位距，18.70-45.90),123名参与者中的119名(96.7%)为白人。基线特征没有差异，脱垂阶段，或组间执行的程序类型。大多数参与者同时进行子宫骶韧带悬吊术和前后修复。值得注意的是，123名参与者中有50名（41％）患有尿道中段吊索。此外，123名参与者中有61名（50％）在手术当天出院。术后3.5至6.0小时阴道疼痛的主要结局没有差异（25vs21mm；P=.285）。此外,术后即刻使用的急救麻醉药量(19.0vs17.0MME;P=.202)在组间没有差异.术后2周，安慰剂组患者对医院疼痛控制(31vs43mm;P=.006)和家庭疼痛控制(31vs42mm;P=.022)的满意度较高.当天出院和过夜入院的人之间没有差异。
骨盆重建手术后立即放置10mg地西泮直肠栓剂并不能改善术后早期的疼痛或麻醉剂使用。尽管安慰剂组报告在手术后2周对疼痛控制的满意度略高，总体疼痛水平较低.因此,我们认为没有必要在术后方案中加用地西泮.
本研究旨在评估地西泮直肠栓剂对盆腔器官脱垂子宫切除术和阴道重建术后早期疼痛的影响。
这是双盲,随机化，安慰剂对照试验比较阴式子宫切除术与天然组织脱垂修复术后疼痛评分.患者被随机分配接受直肠内10mg地西泮栓剂或相同的安慰剂。此外，参与者在基线时完成了问卷，术后第1天上午和术后2周。调查包括疼痛的视觉模拟量表，经过验证的手术满意度问卷，以及有关药物副作用和术后恢复的询问。主要结果是手术后约3小时基于视觉模拟量表的疼痛评分。次要结果包括手术后的总吗啡当量，患者对疼痛控制的满意度，当天出院结果，和总体满意度。卡方，费希尔确切,并且使用了Mann-Whitney测试。基于使用视觉模拟量表在术后阴道疼痛中10毫米的差异，样本量计算为每只手臂55名患者，以达到80%的功率，α为0.05。
从2020年2月到2021年8月，130名参与者被随机分配。在这些参与者中，7退出，分析了123例：地西泮组60例，安慰剂组63例。中位年龄为65岁(四分位距，27-80),中位体重指数为27.9kg/m2(四分位距，18.70-45.90),123名参与者中的119名(96.7%)为白人。基线特征没有差异，脱垂阶段，或组间执行的程序类型。大多数参与者同时进行子宫骶韧带悬吊术和前后修复。值得注意的是，123名参与者中有50名（41％）患有尿道中段吊索。此外，123名参与者中有61名（50％）在手术当天出院。术后3.5至6.0小时阴道疼痛的主要结局没有差异（25vs21mm；P=.285）。此外,术后即刻使用的急救麻醉药量(19.0vs17.0MME;P=.202)在组间没有差异.术后2周，安慰剂组患者对医院疼痛控制(31vs43mm;P=.006)和家庭疼痛控制(31vs42mm;P=.022)的满意度较高.当天出院和过夜入院的人之间没有差异。
骨盆重建手术后立即放置10mg地西泮直肠栓剂并不能改善术后早期的疼痛或麻醉剂使用。尽管安慰剂组报告在手术后2周对疼痛控制的满意度略高，总体疼痛水平较低.因此,我们认为没有必要在术后方案中加用地西泮.
