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前瞻性随机双盲安慰剂对照试验研究腹腔镜腹疝修补术后使用弹性体疼痛泵装置。

Prospective randomized double-blind placebo-controlled trial of postoperative elastomeric pain pump devices used after laparoscopic ventral hernia repair.

机构信息

Department of General Surgery, Case Medical Center, University Hospitals of Cleveland, 11100 Euclid Avenue, Cleveland, OH 44106, USA.

出版信息

Surg Endosc. 2009 Dec;23(12):2637-43. doi: 10.1007/s00464-009-0470-y. Epub 2009 Apr 9.

DOI:10.1007/s00464-009-0470-y
PMID:19357918
Abstract

BACKGROUND

The laparoscopic repair of ventral hernias can result in significant postoperative pain necessitating a prolonged hospital stay, increased narcotic use, and patient dissatisfaction. Elastomeric pain pump devices with local analgesics may significantly reduce postoperative discomfort after laparoscopic ventral hernia repair. This prospective randomized, double-blind, placebo-controlled study evaluated the effect of local anesthetic continuously infused with an elastomeric pain pump device to reduce postoperative pain.

METHODS

After institutional review board approval of the study, all patients undergoing laparoscopic ventral hernia repair consented to participate. Standardized technique included routine transfascial fixation sutures and titanium spiral tacks. Elastomeric pain pumps were placed percutaneously just above the mesh in the hernia sac. For 48 h postoperatively, 100 ml of continuous 0.5% Marcaine or normal saline was used at 2 ml/h. Postoperatively, the patients were evaluated every 8 h for the first 72 h, then after 2 weeks, 6 weeks, and 3 months for pain scores, narcotic usage (both oral and intravenous), return of flatus, length of hospital stay, and postoperative complications.

RESULTS

Of the 73 patients enrolled in the study, 37 received 0.5% Marcaine, and 36 received placebo. Despite randomization, the control group had significantly more obese patients (mean body mass index [BMI], 39 vs. 33 kg/m(2); p = 0.005), and more recurrent hernias (40% vs. 19%; p = 0.05), and also tended to have more prior hernia repairs (0.8 vs. 0.3; p = 0.06). There were no significant differences between the two groups in terms of operative times (p = 0.7), hernia size (p = 0.9), mesh size (p = 0.6), number of transfascial fixation sutures (p = 0.4), or number of spiral tacks (p = 0.13). Postoperative visual analog pain scores, usage of oral or intravenous narcotics, and morphine equivalents were similar between the two groups at all study points (p > 0.05). There were no significant differences between the two groups based on return of bowel function, toleration of a regular diet, or length of hospital stay. No postoperative complications directly related to the catheter were observed.

CONCLUSIONS

This prospective randomized double-blind, placebo-controlled trial showed no advantage of an elastomeric pain pump device in terms of providing a measurable reduction in postoperative pain scores, narcotic use, time to return of bowel function, or length of hospital stay after laparoscopic ventral hernia repair. Further studies are warranted to determine other alternatives for reducing postoperative pain after laparoscopic ventral hernia repair.

摘要

背景

腹腔镜修复腹疝会导致明显的术后疼痛,需要延长住院时间、增加麻醉药物的使用,并导致患者不满意。带有局部麻醉剂的弹性止痛泵装置可能会显著减轻腹腔镜腹疝修复后的术后不适。这项前瞻性随机、双盲、安慰剂对照研究评估了持续输注局部麻醉剂的弹性止痛泵装置对减轻术后疼痛的效果。

方法

在机构审查委员会批准该研究后,所有接受腹腔镜腹疝修复的患者均同意参与。标准化技术包括常规筋膜内固定缝线和钛螺旋钉。弹性止痛泵通过皮穿刺放置在疝囊内的网片上方。术后 48 小时内,以 2ml/h 的速度连续使用 100ml 的 0.5%布比卡因或生理盐水。术后前 72 小时,每 8 小时评估一次患者,然后在术后 2 周、6 周和 3 个月时评估疼痛评分、麻醉药物使用(口服和静脉)、排气恢复、住院时间和术后并发症。

结果

在纳入研究的 73 名患者中,37 名患者接受了 0.5%布比卡因,36 名患者接受了安慰剂。尽管进行了随机分组,但对照组肥胖患者明显较多(平均体重指数[BMI],39 与 33kg/m²;p=0.005),且复发疝更多(40%与 19%;p=0.05),且既往疝修补术也更多(0.8 与 0.3;p=0.06)。两组在手术时间(p=0.7)、疝大小(p=0.9)、网片大小(p=0.6)、筋膜内固定缝线数量(p=0.4)或螺旋钉数量(p=0.13)方面均无显著差异。两组在所有研究时间点的术后视觉模拟疼痛评分、口服或静脉麻醉药物使用以及吗啡当量均相似(p>0.05)。两组在肠功能恢复、接受常规饮食和住院时间方面也无显著差异。未观察到与导管直接相关的术后并发症。

结论

这项前瞻性随机、双盲、安慰剂对照试验表明,弹性止痛泵装置在提供可衡量的术后疼痛评分、麻醉药物使用、肠功能恢复时间或腹腔镜腹疝修复后住院时间方面没有优势。需要进一步的研究来确定其他减少腹腔镜腹疝修复后术后疼痛的替代方法。

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