Multimodal Analgesia Effect on Post Surgical Patient
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change In Post Operative Pain Intensity
研究概览
简要总结
Patients undergoing Bariatric Surgery at the University of California Davis Medical Center will be divided into two groups, one receiving Standard of Care pain control medications vs the second group which will receive non-narcotic pain medications with rescue pain medications available if needed
详细描述
Pain control after weight loss surgery is challenging due to the alteration of digestive system anatomy and limitation on using medications which can either be crushed or in liquid form for the first 10 days to 14 days after surgery. Additionally there are multiple programs in place to eliminate the use of narcotic/opioid based pain medications due their potential addictive risks.
This study compares two groups of patients whom will have Roux en Y Gastric Bypass Surgery at UC Davis Medical Center, the control group will receive standard of care pain control medications (including opioid based medications) compared to the research arm, this group will receive Gabapentinin and Tylenol for pain control after surgery with rescue pain medications available if needed.
Post surgery both groups will be managed by the Bariatric Surgery Team and will be contacted periodically as part of the standard of care to monitor pain control and usage of any rescue medications (if needed).
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
盲法说明
Patients agreeing to participate in the study will be assigned one of two treatment arms. Neither the care team nor the patient will be masked.
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who undergo index weight loss procedures at UC Davis Medical Center
- •Women with a BMI =>30
- •Age from 35-65
- •American Society of Anesthesiology (ASA) score of 3 or less
- •No previous history of prior abdominal/foregut surgery
排除标准
- •Not having an index weight los surgery for obesity
- •Do not meet the NIH Standards for weight loss surgery
- •Additional planned or unplanned procedures during the index surgical procedure such as Cholecystectomy or extensive lysis of adhesions (>30 minutes)
- •BMI < 30
- •Women considering or currently planning on gender altering/modification
- •ASA score of 4 or higher
- •Patients less than 35 years of age or older than 65 years of age at the time of surgical consent
- •A history of open abdominal surgery including umbilical, ventral, or splengalic hernia repair with or without mesh implantation, transplant or vascular surgery or any foregut procedures including hiatal hernia repair or anti-reflux surgery
- •Arthritis, Fibromyalgia, chronic pain syndrome
- •Other conditions requiring daily use of oral pain medications
- •Prisoners
- •Allergy to Gabapentin
研究组 & 干预措施
Standard of Care
The group will receive the standard of care pain control protocol after index Bariatric Surgery which includes the use of a PCA (patient controlled analgesia) with Dilaudid or Morphine Sulphate, transitioning to oral narcotic based pain control medications.
干预措施: Oxycodone Hydrochloride (Drug)
Standard of Care
The group will receive the standard of care pain control protocol after index Bariatric Surgery which includes the use of a PCA (patient controlled analgesia) with Dilaudid or Morphine Sulphate, transitioning to oral narcotic based pain control medications.
干预措施: Ativan (Drug)
Multi-Modal
Patients will receive Gabapentin pre-operatively on-call 120 minutes prior to surgery starting. Patients at the conclusion of surgery will have additional doses of Ofirmev (IV Tylenol) and Gabapentin via IV based on patients pre-operative weight. Post surgery the patient will be transitioned to oral pain medications (Tylenol and Gabapentin) with rescue medications available for breakthrough pain control.
干预措施: Neurontin (Drug)
Multi-Modal
Patients will receive Gabapentin pre-operatively on-call 120 minutes prior to surgery starting. Patients at the conclusion of surgery will have additional doses of Ofirmev (IV Tylenol) and Gabapentin via IV based on patients pre-operative weight. Post surgery the patient will be transitioned to oral pain medications (Tylenol and Gabapentin) with rescue medications available for breakthrough pain control.
干预措施: Ativan (Drug)
Multi-Modal
Patients will receive Gabapentin pre-operatively on-call 120 minutes prior to surgery starting. Patients at the conclusion of surgery will have additional doses of Ofirmev (IV Tylenol) and Gabapentin via IV based on patients pre-operative weight. Post surgery the patient will be transitioned to oral pain medications (Tylenol and Gabapentin) with rescue medications available for breakthrough pain control.
干预措施: Zofran Injection (Drug)
Standard of Care
The group will receive the standard of care pain control protocol after index Bariatric Surgery which includes the use of a PCA (patient controlled analgesia) with Dilaudid or Morphine Sulphate, transitioning to oral narcotic based pain control medications.
干预措施: Dilaudid Injectable Product (Drug)
Standard of Care
The group will receive the standard of care pain control protocol after index Bariatric Surgery which includes the use of a PCA (patient controlled analgesia) with Dilaudid or Morphine Sulphate, transitioning to oral narcotic based pain control medications.
干预措施: Marcaine Injectable Product (Drug)
Standard of Care
The group will receive the standard of care pain control protocol after index Bariatric Surgery which includes the use of a PCA (patient controlled analgesia) with Dilaudid or Morphine Sulphate, transitioning to oral narcotic based pain control medications.
干预措施: Zofran Injection (Drug)
Standard of Care
The group will receive the standard of care pain control protocol after index Bariatric Surgery which includes the use of a PCA (patient controlled analgesia) with Dilaudid or Morphine Sulphate, transitioning to oral narcotic based pain control medications.
干预措施: Scopolamine patch (Drug)
Standard of Care
The group will receive the standard of care pain control protocol after index Bariatric Surgery which includes the use of a PCA (patient controlled analgesia) with Dilaudid or Morphine Sulphate, transitioning to oral narcotic based pain control medications.
干预措施: Flexeril Oral Product (Drug)
Multi-Modal
Patients will receive Gabapentin pre-operatively on-call 120 minutes prior to surgery starting. Patients at the conclusion of surgery will have additional doses of Ofirmev (IV Tylenol) and Gabapentin via IV based on patients pre-operative weight. Post surgery the patient will be transitioned to oral pain medications (Tylenol and Gabapentin) with rescue medications available for breakthrough pain control.
干预措施: Dilaudid Injectable Product (Drug)
Multi-Modal
Patients will receive Gabapentin pre-operatively on-call 120 minutes prior to surgery starting. Patients at the conclusion of surgery will have additional doses of Ofirmev (IV Tylenol) and Gabapentin via IV based on patients pre-operative weight. Post surgery the patient will be transitioned to oral pain medications (Tylenol and Gabapentin) with rescue medications available for breakthrough pain control.
干预措施: Marcaine Injectable Product (Drug)
Multi-Modal
Patients will receive Gabapentin pre-operatively on-call 120 minutes prior to surgery starting. Patients at the conclusion of surgery will have additional doses of Ofirmev (IV Tylenol) and Gabapentin via IV based on patients pre-operative weight. Post surgery the patient will be transitioned to oral pain medications (Tylenol and Gabapentin) with rescue medications available for breakthrough pain control.
干预措施: Oxycodone Hydrochloride (Drug)
Multi-Modal
Patients will receive Gabapentin pre-operatively on-call 120 minutes prior to surgery starting. Patients at the conclusion of surgery will have additional doses of Ofirmev (IV Tylenol) and Gabapentin via IV based on patients pre-operative weight. Post surgery the patient will be transitioned to oral pain medications (Tylenol and Gabapentin) with rescue medications available for breakthrough pain control.
干预措施: Hycet 7.5Mg-325Mg/15Ml Solution (Drug)
Multi-Modal
Patients will receive Gabapentin pre-operatively on-call 120 minutes prior to surgery starting. Patients at the conclusion of surgery will have additional doses of Ofirmev (IV Tylenol) and Gabapentin via IV based on patients pre-operative weight. Post surgery the patient will be transitioned to oral pain medications (Tylenol and Gabapentin) with rescue medications available for breakthrough pain control.
干预措施: Scopolamine patch (Drug)
Multi-Modal
Patients will receive Gabapentin pre-operatively on-call 120 minutes prior to surgery starting. Patients at the conclusion of surgery will have additional doses of Ofirmev (IV Tylenol) and Gabapentin via IV based on patients pre-operative weight. Post surgery the patient will be transitioned to oral pain medications (Tylenol and Gabapentin) with rescue medications available for breakthrough pain control.
干预措施: Flexeril Oral Product (Drug)
Standard of Care
The group will receive the standard of care pain control protocol after index Bariatric Surgery which includes the use of a PCA (patient controlled analgesia) with Dilaudid or Morphine Sulphate, transitioning to oral narcotic based pain control medications.
干预措施: Hycet 7.5Mg-325Mg/15Ml Solution (Drug)
Multi-Modal
Patients will receive Gabapentin pre-operatively on-call 120 minutes prior to surgery starting. Patients at the conclusion of surgery will have additional doses of Ofirmev (IV Tylenol) and Gabapentin via IV based on patients pre-operative weight. Post surgery the patient will be transitioned to oral pain medications (Tylenol and Gabapentin) with rescue medications available for breakthrough pain control.
干预措施: Tylenol Suspension (Drug)
结局指标
主要结局
Change In Post Operative Pain Intensity
时间窗: 3 Days and 14 Days Post Surgery
Using the Wong-Baker Pain Rating Scale-0=No Pain, 2-4, Slight Pain, 6-8, Moderate Pain, 9-10, Severe Pain
Change in Oral Morphine Equivalence (OME) from 3 days and 14 days post surgery
时间窗: 3 Days and 14 Days Post Surgery
OME Table is used to measure opioid use post surgery
次要结局
未报告次要终点