Addition of Methocarbamol to Postoperative Multimodal Analgesic Regimen: A Prospective, Randomized Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Proportion of patients requiring a rescue opioid prescription
研究概览
简要总结
The purpose of this study is to gather information on methocarbamol as a pain management treatment for ventral or inguinal hernia repair.
Methocarbamol has been part of the pain management treatment for both inpatient and outpatient procedures at Prisma Health. This study will compare the outcomes of patients who receive methocarbamol, those who receive the standard opioid pain management treatment, and those who receive methocarbamol plus the standard opioid pain management treatment.
Participants will be randomized into one of the study groups listed below.
Primary ventral hernia repair or inguinal hernia repair:
Group 1: standard opioid after surgery Group 2: methocarbamol after surgery
Open or robotic ventral hernia repair outpatient:
Group 1: standard opioid after surgery Group 2: standard opioid plus methocarbamol after surgery
Open or robotic ventral hernia repair inpatient:
Group 1: standard opioid at discharge Group 2: standard opioid plus methocarbamol at discharge
A total of 200 participants will be included in the study.
Participation will last for about 30 days after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing open primary ventral hernia repair (group 1)
- •Patients undergoing inguinal hernia repair (open, laparoscopic, or robotic; group 2)
- •Patients undergoing open incisional hernia repair (group 3)
- •Robotic repair ventral or incisional hernias (group 4)
- •Given consent for randomization
排除标准
- •Pregnancy
- •Chronic opioid users
研究组 & 干预措施
open or robotic hernia repair inpatient
Open repair of ventral incisional hernias. Robotic repair of ventral primary or incisional hernias.
干预措施: Standard Opioid (Drug)
open or robotic ventral hernia repair outpatient
Open repair of ventral incisional hernias. Robotic repair of ventral primary or incisional hernias.
干预措施: Standard opioid plus methocarbamol (Drug)
primary ventral hernia repair or inguinal hernia repair
Primary ventral hernias, including umbilical, epigastric, and Spigelian hernias.
Primary or recurrent inguinal hernias.
干预措施: Standard Opioid (Drug)
open or robotic ventral hernia repair outpatient
Open repair of ventral incisional hernias. Robotic repair of ventral primary or incisional hernias.
干预措施: Standard Opioid (Drug)
open or robotic hernia repair inpatient
Open repair of ventral incisional hernias. Robotic repair of ventral primary or incisional hernias.
干预措施: Standard opioid plus methocarbamol (Drug)
primary ventral hernia repair or inguinal hernia repair
Primary ventral hernias, including umbilical, epigastric, and Spigelian hernias.
Primary or recurrent inguinal hernias.
干预措施: Methocarbamol (Drug)
结局指标
主要结局
Proportion of patients requiring a rescue opioid prescription
时间窗: 30 days post surgery
The proportion of patients requiring a rescue opioid prescription will be compared between the study and control groups using the Fisher's Exact Test (bivariate analysis). Multiple logistic regression analysis will then be used to test for a difference in this outcome, adjusting for any baseline differences between the 2 study groups.
Average total morphine milligram equivalents (MME) consumption
时间窗: 30 days post surgery
Average total MME consumption will be compared between the study and control groups using either the Student's T-test or the Wilcoxon Rank Sum Test (depends on distribution of the data -- parametric vs. non-parametric).
次要结局
- European Registry of Abdominal Wall Hernias (EuraHS) Quality of Life tool scores(30 days post surgery)
- Visual Analog Scale pain scores(7 days post surgery)