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临床试验/NCT06659965
NCT06659965已完成不适用

Intravenous Methocarbamol for Acute Pain After Spine Surgery

The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 1,270 人开始时间: 2020年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
1,270
试验地点
1
主要终点
Time-Weighted Average Pain Score

研究概览

简要总结

The goal of this target trial emulation is to evaluate the impact of intravenous (IV) methocarbamol on postoperative pain and opioid use in adults undergoing elective spine surgery. The main questions it aims to answer are:

  • Does IV methocarbamol reduce pain in the 6 hours following surgery?
  • Does IV methocarbamol decrease the need for opioid pain medications in the same period?

Participants who receive IV methocarbamol as part of their routine postoperative care will have their pain scores and opioid consumption tracked for 6 hours after treatment. Pain levels will be measured using standard assessments, and opioid use will be quantified in oral morphine equivalents.

详细描述

The IMAPSS study is a target trial emulation evaluating the effect of intravenous (IV) methocarbamol on postoperative pain management and opioid consumption in adult patients undergoing elective spine surgery. The study employs a target trial emulation design to simulate the conditions of a randomized controlled trial using observational data extracted from electronic medical records. The main focus is to determine if administering IV methocarbamol within two hours after surgery reduces postoperative pain scores and opioid use.

Patients will be tracked from the point of their first recorded pain score in the Post-Anesthesia Care Unit (PACU) after surgery to assess for treatment assignment eligibility. Data will be collected at 15-minute intervals, which corresponds to the standard assessment frequency in Phase I PACU care, for up to 12 hours postoperatively for each patient. The primary analysis will use time-varying propensity score matching (TV-PSM) to control for baseline and time-varying confounders. Pain levels will be measured using a time-weighted average (TWA) of pain scores, and opioid consumption will be quantified in oral morphine equivalents (OME).

The primary analysis will utilize TV-PSM, with propensity scores estimated through a Cox proportional hazards model. Matching will create balanced treatment groups at each 15-minute interval. Generalized estimating equations (GEE) will then estimate the effect of IV methocarbamol on the primary outcome (TWA pain) and secondary outcome (cumulative OME) over a 6-hour postoperative period. As a sensitivity analysis, a marginal structural model (MSM) using inverse probability weighting (IPW) will assess the robustness of the findings to the time-varying confounder adjustment.

This study's findings will aim to inform evidence-based recommendations for postoperative pain management and opioid-sparing strategies, potentially providing safer alternatives to conventional opioid-based regimens.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • Undergoing one of the following three elective spine surgeries: (i) Anterior Cervical Discectomy and Fusion (ACDF), (ii) Posterior Spinal Fusion, or (iii) Laminectomy, Laminotomy, or Discectomy
  • At least 8h of valid pain scores recorded postoperatively

排除标准

  • Emergency Surgery
  • Pregnancy
  • Sensitivity to methocarbamol (allergy)
  • End-stage renal disease (ESRD)
  • Myasthenia gravis
  • Missing a valid electronic anesthesia record

研究组 & 干预措施

IV methocarbamol

Patients who received intravenous methocarbamol

干预措施: Intravenous Methocarbamol (Drug)

结局指标

主要结局

Time-Weighted Average Pain Score

时间窗: 6 hours after treatment assignment

The primary outcome of this study is the Time-Weighted Average (TWA) pain score measured over the 6-hour period following treatment assignment. Pain scores are collected using a standardized numerical pain rating scale, ranging from 0 (no pain) to 10 (worst possible pain). These scores are assessed in 15-minute intervals, the standard frequency for Phase I PACU assessments, throughout the 6-hour follow-up period. The TWA pain score is calculated by averaging these pain ratings, giving greater weight to scores recorded more frequently or for longer periods. This method provides a comprehensive summary of the patient's pain experience over the observed time frame, accounting for fluctuations in pain intensity during recovery. A lower TWA score indicates better pain control and a potentially greater effect of the intervention.

次要结局

  • Cumulative Opioid Use(6 hours after treatment assignment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul Potnuru

Associate Professor

The University of Texas Health Science Center, Houston

研究点 (1)

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