Optimal Multimodal Pain Management Package Versus Regular Bottled Pain Formulation for Outpatient Use Following Microdiscectomies , Foraminotomies, and Spinal Decompressions: A Randomized Control Trial Comparing Two Strategies
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 100
- 主要终点
- Satisfaction measured by Satisfaction Likert Scale
研究概览
简要总结
The purpose of this research is to compare two outpatient pain management strategies in patients undergoing spinal surgeries such as microdiscectomies, foraminotomies, and spinal decompressions.
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
- •Adults: males or non-pregnant females.
- •Patients undergoing ambulatory microdiscectomies, foraminotomies, and spinal cord decompressions requiring pain control analgesics.
排除标准
- •Pregnancy
- •Active severe liver disease
- •Chronic kidney disease 3a-5 (moderate to severe)
- •Chronic obstructive pulmonary disease with impaired pulmonary function
- •Chronic steroid use
- •Chronic opioid use
- •Current use of narcotics
- •Allergy to sulfonamides
- •Allergy to NSAIDs
- •Allergy to Aspirin
- •Allergy to Tylenol
- •Allergy to Gabapentins
- •Allergy to H2 blockers (cimetidine, famotidine)
- •Allergy to steroid
- •Current use of gabapentins for any medical condition
- •Inability to be discharged home on the day of surgery
- •Inability to swallow pills
- •Myasthenia gravis
- •History of gastrointestinal ulcers or stomach bleeding
- •Have any condition that, in the investigator's opinion, will compromise the well-being of the patient or the study, or prevent the patient from meeting or performing study requirements.
研究组 & 干预措施
Bottled pain formulations Group
Participants in this group will use the standard-of-care medication treatment for ambulatory spinal surgery prescribed to them in different bottles for 7 days.
干预措施: Acetaminophen (Drug)
Bottled pain formulations Group
Participants in this group will use the standard-of-care medication treatment for ambulatory spinal surgery prescribed to them in different bottles for 7 days.
干预措施: Celebrex (Drug)
Bottled pain formulations Group
Participants in this group will use the standard-of-care medication treatment for ambulatory spinal surgery prescribed to them in different bottles for 7 days.
干预措施: Gabapentin (Drug)
Bottled pain formulations Group
Participants in this group will use the standard-of-care medication treatment for ambulatory spinal surgery prescribed to them in different bottles for 7 days.
干预措施: Famotidine (Drug)
Bottled pain formulations Group
Participants in this group will use the standard-of-care medication treatment for ambulatory spinal surgery prescribed to them in different bottles for 7 days.
干预措施: Decadron (Drug)
Bottled pain formulations Group
Participants in this group will use the standard-of-care medication treatment for ambulatory spinal surgery prescribed to them in different bottles for 7 days.
干预措施: Oxycodone (Drug)
Multi-Modal regimen Group
Participants in this group will receive the same drugs used during the standard-of-care treatment for ambulatory spinal surgery. However, the drugs will be prescribed using a simple multimodal medication pre-formulated package for 7 days.
干预措施: Acetaminophen (Drug)
Multi-Modal regimen Group
Participants in this group will receive the same drugs used during the standard-of-care treatment for ambulatory spinal surgery. However, the drugs will be prescribed using a simple multimodal medication pre-formulated package for 7 days.
干预措施: Celebrex (Drug)
Multi-Modal regimen Group
Participants in this group will receive the same drugs used during the standard-of-care treatment for ambulatory spinal surgery. However, the drugs will be prescribed using a simple multimodal medication pre-formulated package for 7 days.
干预措施: Gabapentin (Drug)
Multi-Modal regimen Group
Participants in this group will receive the same drugs used during the standard-of-care treatment for ambulatory spinal surgery. However, the drugs will be prescribed using a simple multimodal medication pre-formulated package for 7 days.
干预措施: Famotidine (Drug)
Multi-Modal regimen Group
Participants in this group will receive the same drugs used during the standard-of-care treatment for ambulatory spinal surgery. However, the drugs will be prescribed using a simple multimodal medication pre-formulated package for 7 days.
干预措施: Decadron (Drug)
Multi-Modal regimen Group
Participants in this group will receive the same drugs used during the standard-of-care treatment for ambulatory spinal surgery. However, the drugs will be prescribed using a simple multimodal medication pre-formulated package for 7 days.
干预措施: Oxycodone (Drug)
结局指标
主要结局
Satisfaction measured by Satisfaction Likert Scale
时间窗: up to 7 days
Scores range from "0" not satisfied to "10" very satisfied
Adherence measured by the self-report medication nonadherence scale
时间窗: up to 7 days
Adherence will be measured using a Likert scale ranging from "never" indicating that the participant followed all instructions and adhered to the medication to "all the time. "indicating that the participant never followed instructions and did not take the medication.
Ease of use as measured by Likert Scale
时间窗: up to 7 days
Scores ranges from "strongly disagree to Strongly agree" regarding the ease of use of the medication package.
次要结局
- Number of pain pills(up to 7 days)
研究者
Yiliam Rodriguez
Professor of Clinical
University of Miami