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临床试验/NCT06917118
NCT06917118尚未招募不适用

Multimodal Pain Management After Wide Awake Local Anesthesia No Tourniquet Orthopedic Hand Surgery: A Randomized Control Trial

University of Puerto Rico1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年5月1日最近更新:
干预措施

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

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

Active Comparator

10 pills of 5mg oxycodone Q4hrs as needed

干预措施: Oxycodone 5mg taken first (Drug)

Postoperative Opioid-sparing Multimodal analgesia

Experimental

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

Experimental

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

Experimental

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

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

Daniel Deliz

Dr. Christian A. Foy

University of Puerto Rico

研究点 (1)

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