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机器人辅助内镜甲状腺手术后疼痛的围手术期应用普瑞巴林:一项随机临床试验。

Perioperative administration of pregabalin for pain after robot-assisted endoscopic thyroidectomy: a randomized clinical trial.

机构信息

Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine, 250 Seongsan-no, Seodaemun-gu, Seoul, 120-752, Republic of Korea.

出版信息

Surg Endosc. 2010 Nov;24(11):2776-81. doi: 10.1007/s00464-010-1045-7. Epub 2010 Apr 8.

Abstract

BACKGROUND

Perioperative administration of pregabalin, which is effective for neuropathic pain, might reduce early postoperative and chronic pain. This randomized, double-blinded, placebo-controlled trial (Clinical Trials.gov ID NCT00905580) was designed to investigate the efficacy and safety of pregabalin for reducing both acute postoperative pain and the development of chronic pain in patients after robot-assisted endoscopic thyroidectomy.

METHODS

Ninety-nine patients were randomly assigned to groups that received pregabalin 150 mg or placebo 1 h before surgery, with the dose repeated after 12 h. Assessments of pain and side effects were performed 48 h postoperatively. The incidences of chronic pain and hypoesthesia in the anterior chest were recorded 3 months after surgery.

RESULTS

Ninety-four patients completed the study. Verbal numerical rating scale scores for pain and the need for additional analgesics were lower in the pregabalin group (n = 47) than the placebo group (n = 47) during 48 h postoperatively (P < 0.05). However, incidences of sedation and dizziness were higher in the pregabalin group (P < 0.05). There were no differences between the groups in the incidences of chronic pain and chest hypoesthesia at 3 months after surgery.

CONCLUSIONS

Perioperative administration of pregabalin (150 mg twice per day) was effective in reducing early postoperative pain but not chronic pain in patients undergoing robot-assisted endoscopic thyroidectomy. Caution should be taken regarding dizziness and sedation.

摘要

背景

普瑞巴林可有效治疗神经性疼痛,围手术期使用可能会减轻术后早期疼痛和慢性疼痛。本随机、双盲、安慰剂对照试验(ClinicalTrials.gov 注册号:NCT00905580)旨在研究普瑞巴林对减轻机器人辅助内镜甲状腺切除术后患者急性术后疼痛和慢性疼痛发展的疗效和安全性。

方法

99 例患者随机分为术前 1 小时服用普瑞巴林 150mg 或安慰剂组,12 小时后重复给药。术后 48 小时评估疼痛和不良反应。术后 3 个月记录慢性疼痛和前胸感觉迟钝的发生率。

结果

94 例患者完成了研究。术后 48 小时内,普瑞巴林组(n=47)的疼痛视觉模拟评分和需要额外镇痛药物的患者比例均低于安慰剂组(n=47)(P<0.05)。然而,普瑞巴林组的镇静和头晕发生率更高(P<0.05)。两组患者术后 3 个月慢性疼痛和前胸感觉迟钝的发生率无差异。

结论

机器人辅助内镜甲状腺切除术中,围手术期给予普瑞巴林(每天两次,每次 150mg)可有效减轻术后早期疼痛,但不能减轻慢性疼痛。应注意头晕和镇静的发生。

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