Postoperative Pain Management in Rhinoplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Pain Intensity Visual Analog Scale (VAS)- 0-100 (0- no Pain and 100- Most Severe Pain)
研究概览
简要总结
The primary purpose of the study is to determine adequacy of postoperative pain control after nasal surgery in patients prescribed Acetaminophen (325mg) + Hydrocodone (5mg) compared to Acetaminophen(325mg) + Ibuprofen (200mg)for a period of 5 days after nasal surgery. To assess the degree of pain, the participants will score the intensity of their pain on a visual analog scale(VAS)of 0-100points (0- no pain and 100- most severe pain), preoperatively and postoperatively (to be documented before each dose) for the duration of the prescribed medications .
Additionally, the study will also seek to track:
- The total number of pills each patients consume from the prescribed 5 day regimen.
- Any associated side effects.
- Additional pain medications prescribed in case of inadequate pain control, postoperatively.
详细描述
From this study, the investigators hope to learn the following:
- Is adequate postoperative pain management after nasal surgery achieved with opioid or non-opioid drugs?
- If opioid drugs are required for adequate pain control postoperatively, is it possible to reduce the number of days the drugs are prescribed for?
- What are the common side effect profiles of the included drugs?
In light of the current opioid epidemic in the country, it is important the the physicians explore the utility of drugs other than opioids for adequate postoperative pain management. Also, reducing the dosage and/or number of prescribed opioid drugs lessens the propensity for misuse of physician prescribed opioid medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Minimum age of 18 years
- •Able to speak and understand english.
- •Undergoing rhinoplasty for cosmetic purposes
- •Undergoing rhinoplasty for treatment of nasal obstruction
排除标准
- •Less than 18 years of age
- •Cannot speak and understand english
- •Patients who have undergone nasal surgery in the past
- •Patients not undergoing nasal surgery
- •Women will be excluded if they are either pregnant or lactating as this population does not undergo nasal surgery at our center.
- •Patients with any known allergies to the class of pain medications used in the study.
- •Please note: Any person interested in this clinical trial should contact the Facial Plastic and Reconstructive Surgery clinic at (650) 736 - 3223 to schedule a consultation with Dr. Sam P. Most to assess their eligibility for the trial. Please note, enrolling in the clinical trial will not entitle the participant to a waiver of charges associated with undergoing nasal surgery.
研究组 & 干预措施
Drug Arm A
Norco 5mg-325 mg Tablet, administered orally every 4 hours for 5 days total
干预措施: Norco 5Mg-325Mg Tablet (Drug)
Drug Arm B
Tylenol 325 mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total.
干预措施: Tylenol 325Mg Caplet (Drug)
Drug Arm B
Tylenol 325 mg Caplet, administered orally every 4 hours for 5 days total. Ibuprofen 200 mg administered orally every 4 hours for 5 days total.
干预措施: Ibuprofen 200 mg (Drug)
结局指标
主要结局
Pain Intensity Visual Analog Scale (VAS)- 0-100 (0- no Pain and 100- Most Severe Pain)
时间窗: 5 days post-operative [up to approximately 5 weeks post-baseline]
Self reported pain intensity at every prescribed dose averaged over a period of 5 days.
次要结局
- Number of Study Drugs (Doses) Utilized(5 days)
- Number of Tramadol Doses Utilized(5 days)
- Number Patients Who Reported Adequate Pain Control(5 days)
- Side Effects of Pain Medications(5 days)
- Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) Questionnaire(Baseline and post-operative follow-up (up to an average of 12 months following procedure))
- Visual Analog Scale-Functional (VAS-F)(Baseline and post-operative follow-up (up to an average of 12 months following procedure))
- Visual Analog Scale-Aesthetic (VAS-A)(Baseline and post-operative follow-up (up to an average of 12 months following procedure))
- Eyelid Edema Score(Post-operative day 7)
- Ecchymosis Score(Post-operative day 7)
- Subconjunctival Hemorrhage Score(Post-operative day 7)
研究者
Sam P. Most
Chief, Division of Facial Plastic and Reconstructive Surgery
Stanford University