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Tapentadol vs Pregabalin for Postoperative Pain in Lower Limb Surgery

2026年5月13日 更新者：Mirna Magali Delgado Carlo、ISSSTE Hospital Regional "Gral. Ignacio Zaragoza"

Oral Premedication With Tapentadol Versus Pregabalin for Acute Postoperative Pain in Lower Limb Surgery Under Neuraxial Anesthesia: A Pilot Randomized Controlled Trial

This pilot randomised controlled trial compared 72-hour oral premedication with tapentadol (50 mg every 12 hours) versus pregabalin (75 mg every 24 hours) for preventing acute postoperative pain in 46 patients undergoing elective lower limb surgery under neuraxial anaesthesia. The primary outcome was pain intensity measured by the Numeric Rating Scale (NRS 0-10) at PACU arrival and at 30, 60, 90, and 120 minutes thereafter. Secondary outcomes included Verbal Rating Scale scores, rescue morphine consumption, and safety (nausea/vomiting, hypersensitivity).

研究概览

地位

完全的

条件

干预/治疗

详细说明

Acute postoperative pain affects over 80% of surgical patients, with orthopaedic lower limb procedures causing particularly severe pain. Preemptive analgesia may attenuate central sensitisation before surgical incision. Tapentadol (μ-opioid agonist + norepinephrine reuptake inhibitor) and pregabalin (voltage-gated calcium channel modulator) are pharmacologically distinct options, but direct comparative data are lacking.

This single-centre, double-blind, parallel-group pilot randomised controlled trial was conducted at Hospital Regional "General Ignacio Zaragoza," ISSSTE, Mexico City. Forty-six patients (ASA I-II, age 18-50 years, BMI 18-35 kg/m²) scheduled for elective lower limb surgery under neuraxial anaesthesia were randomised 1:1 to receive either tapentadol 50 mg orally every 12 hours (n=23) or pregabalin 75 mg orally every 24 hours (n=23), both initiated 72 hours before surgical incision.

The primary outcome was postoperative pain intensity assessed using the Numeric Rating Scale (NRS 0-10) at PACU arrival (T0) and at 30 (T1), 60 (T2), 90 (T3), and 120 (T4) minutes thereafter. Secondary outcomes included Verbal Rating Scale (VRS) scores, rescue morphine consumption (4 mg IV on request), and incidence of nausea/vomiting and hypersensitivity reactions. The primary longitudinal analysis used a linear mixed model with Group, Time, and Group×Time interaction as fixed effects and a random intercept per patient. Between-group contrasts at each timepoint were derived from estimated marginal means with Holm correction. Effect sizes are reported as Cohen's d.

The trial was approved by the institutional ethics and research committee (RPI #386-2024) and registered with the ISSSTE institutional research registry prior to enrolment. Due to institutional policy restrictions at the time of study initiation, registration on ClinicalTrials.gov was completed after data collection; this is disclosed transparently in accordance with CONSORT 2025 guidance on retrospective registration disclosure.

研究类型

介入性

注册 (实际的)

46

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 墨西哥
    • Mexico City
      • Mexico City、Mexico City、墨西哥、09360
        • Hospital Regional "General Ignacio Zaragoza," ISSSTE

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age 18-50 years
  • ASA physical status I or II
  • Body mass index between 18 and 35 kg/m²
  • Scheduled for elective lower limb surgery under neuraxial anaesthesia
  • Willing to provide written informed consent

Exclusion Criteria:

  • Chronic use of analgesics or gabapentinoids
  • Known hypersensitivity to tapentadol or pregabalin
  • Pre-existing chronic pain

Elimination Criteria:

  • Hypersensitivity reaction to any study drug during administration
  • Hemodynamic shock of any etiology
  • Requirement for advanced airway management or postoperative mechanical ventilation
  • Surgical duration exceeding 120 minutes
  • Requirement of an epidural catheter dose within the first two postoperative hours
  • Voluntary withdrawal of consent at any point

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Tapentadol
Oral tapentadol 50 mg every 12 hours for 72 hours before surgical incision (total daily dose 100 mg).
药品：Tapentadol
Tapentadol 50 mg immediate-release oral tablet administered every 12 hours for 72 hours preoperatively (total of 6 doses).
有源比较器：Pregabalin
Oral pregabalin 75 mg every 24 hours for 72 hours before surgical incision (total daily dose 75 mg).
药品：Pregabalin
Pregabalin 75 mg oral capsule administered every 24 hours for 72 hours preoperatively (total of 3 doses).

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Pain intensity by Numeric Rating Scale (NRS)
大体时间：At PACU arrival (T0), 30 minutes (T1), 60 minutes (T2), 90 minutes (T3), and 120 minutes (T4) post-arrival
Postoperative pain intensity measured using the Numeric Rating Scale (NRS, 0-10; 0 = no pain, 10 = worst imaginable pain). The primary longitudinal analysis used a linear mixed model with Group, Time, and Group×Time interaction as fixed effects and a random intercept per patient. Between-group contrasts at each timepoint were derived from estimated marginal means with Holm correction. Effect sizes reported as Cohen's d.
At PACU arrival (T0), 30 minutes (T1), 60 minutes (T2), 90 minutes (T3), and 120 minutes (T4) post-arrival

次要结果测量

结果测量
措施说明
大体时间
Rescue morphine consumption
大体时间：During the two-hour PACU observation period (T0-T4)
Proportion of patients requiring rescue analgesia (morphine 4 mg IV) and total morphine consumption (mg) in each group.
During the two-hour PACU observation period (T0-T4)
Incidence of nausea and vomiting
大体时间：During the two-hour PACU observation period (T0-T4)
Proportion of patients experiencing nausea and/or vomiting in each group, assessed by clinical observation and patient report.
During the two-hour PACU observation period (T0-T4)
Hypersensitivity reactions
大体时间：From first dose of study medication through 24 hours post-surgery
Incidence of any hypersensitivity or anaphylactic reaction to tapentadol or pregabalin, classified according to Müller criteria.
From first dose of study medication through 24 hours post-surgery
Verbal Rating Scale (VRS) pain category
大体时间：At PACU arrival (T0), 30 minutes (T1), 60 minutes (T2), 90 minutes (T3), and 120 minutes (T4) post-arrival
Pain severity categorised as absence, low, moderate, or severe using the Verbal Rating Scale (VRS). Reported as proportions of patients in each category at each timepoint.
At PACU arrival (T0), 30 minutes (T1), 60 minutes (T2), 90 minutes (T3), and 120 minutes (T4) post-arrival

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

ISSSTE Hospital Regional "Gral. Ignacio Zaragoza"

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年6月19日

初级完成 (实际的)

2024年7月3日

研究完成 (实际的)

2024年7月5日

研究注册日期

首次提交

2026年5月8日

首先提交符合 QC 标准的

2026年5月8日

首次发布 (实际的)

2026年5月14日

研究记录更新

最后更新发布 (实际的)

2026年5月15日

上次提交的符合 QC 标准的更新

2026年5月13日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ISSSTE RPI #386-2024

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual participant data underlying the results reported in this article, along with the full analysis code, will be made available following article publication via the corresponding author's public GitHub repository (https://github.com/phabel-LD).

IPD 共享时间框架

Beginning at the time of article publication, with no end date.

IPD 共享访问标准

Data and code will be publicly available with no access restrictions via GitHub.

IPD 共享支持信息类型

  • 研究方案
  • 分析代码
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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