Multimodal Pain Management After Wide Awake Local Anesthesia No Tourniquet Orthopedic Hand Surgery: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- VAS Pain Scores
研究概览
简要总结
The main objective of the study is to measure the efficacy of a multimodal postoperative pain regimen consisting of oral acetaminophen and naproxen compared to a traditional opioid-only pain regimen following elective wide awake local anesthesia no tourniquet (WALANT) hand surgery in a Hispanic population. The study is a randomized control trial comparing the clinical outcomes of patients undergoing elective WALANT hand surgery performed by a board-certified, fellowship-trained orthopedic hand surgeon (Dr. Christian A. Foy).
The study groups are:
- Control group: standard pain control with opioids
- Experimental group: multimodal non-opioid pain control
Study Outcomes are:
- VAS pain scores (7 days),
- Total opioid usage
- Patient satisfaction
- Adverse events
We hypothesize that patients receiving multimodal pain regimens will report lower opioid use, lower pain scores, and greater satisfaction than patients receiving traditional opioid-only pain management.
详细描述
The main objective of the study is to measure the efficacy of a multimodal postoperative pain regimen consisting of oral acetaminophen and naproxen compared to a traditional opioid-only pain regimen following elective wide awake local anesthesia no tourniquet (WALANT) hand surgery in a Hispanic population. The study is a single-blind, single-center randomized control trial comparing the clinical outcomes of patients undergoing elective WALANT hand surgery performed by a board-certified, fellowship-trained orthopedic hand surgeon (Dr. Christian A. Foy). Patients will be consecutively recruited at the center and randomized in a 1:1 ratio into the control and experimental groups. The control group will receive the standard of care for postoperative pain: 10 pills of 5mg oxycodone Q4hrs as needed. The experimental group will receive 30 pills of 500mg acetaminophen Q4hrs and 30 pills of 500mg naproxen Q4hrs until pain resolves or treatment is completed. The experimental group will also receive 5 tablets of 5mg oxycodone to take Q4hrs as needed for breakthrough pain. Postoperatively, daily pain Visual Analog Scale (VAS) scores, total opioid usage, patient satisfaction, and adverse events will be recorded. We hypothesize that patients receiving multimodal pain regimens will report lower opioid use, lower pain scores, and greater satisfaction than patients receiving traditional opioid-only pain management.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 21-70 years of age undergoing outpatient hand surgery
- •Patients undergoing surgery with WALANT technique
- •Patients who provide written informed consent
排除标准
- •Patients aged 20 and younger, or 71 and older
- •Patient with chronic pain requiring opioid use
- •Pregnant patients
- •Patients who do not self-identify as Hispanic
- •Patients with known allergy to the medication
- •Patients with contraindications for the prescribed medications
研究组 & 干预措施
Standard Postoperative opioid analgesia
10 pills of 5mg oxycodone Q4hrs as needed
干预措施: Oxycodone 5mg taken first (Drug)
Postoperative Opioid-sparing Multimodal analgesia
30 pills of 500mg acetaminophen Q4hrs and 30 pills of 500mg naproxen Q4hrs. Will also receive 5 tablets of 5mg oxycodone to take Q4hrs as needed for breakthrough pain
干预措施: Acetaminophen (Drug)
Postoperative Opioid-sparing Multimodal analgesia
30 pills of 500mg acetaminophen Q4hrs and 30 pills of 500mg naproxen Q4hrs. Will also receive 5 tablets of 5mg oxycodone to take Q4hrs as needed for breakthrough pain
干预措施: Naproxen Tablets, 500 mg (Drug)
Postoperative Opioid-sparing Multimodal analgesia
30 pills of 500mg acetaminophen Q4hrs and 30 pills of 500mg naproxen Q4hrs. Will also receive 5 tablets of 5mg oxycodone to take Q4hrs as needed for breakthrough pain
干预措施: OxyCODONE 5 mg Oral Tablet (Drug)
结局指标
主要结局
VAS Pain Scores
时间窗: From enrollment to the end of treatment at 7 days
VAS pain scores will be assessed using a patient- completed VAS pain questionnaire until 7 days post-op. Patients will take the questionnaire home and report pain scores in the morning and in the afternoon every day for a week.
Patient Satisfaction
时间窗: From enrollment to the end of treatment at 7 days
Patient satisfaction will be assessed using the Patient Satisfaction Questionnaire Short Form (PSQ-18)
Total Opioid Usage
时间窗: From enrollment to the end of treatment at 7 days
Will be reported in as morphine milligram equivalents (MMEs)
次要结局
- Breakthrough Pain(From enrollment to the end of treatment at 7 days)
- Length of Treatment(From enrollment to the end of treatment at 7 days)
- Indication for WALANT surgery(From enrollment to the end of treatment at 7 days)
研究者
Daniel Deliz
Dr. Christian A. Foy
University of Puerto Rico
