Randomized Controlled Study Comparing the Administration of Opioids Epidurally vs IV in Patients Undergoing Laparotomy With an Epidural for Post-Operative Analgesia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- With a local anesthetic epidural, is the epidural administration of opioids similar to opioids administered by intravenous
研究概览
简要总结
The purpose of this research study is to determine if the two common ways of administering additional opioids (morphine like substance, narcotic) with an epidural, either mixed in the epidural solution or given separately through the intravenous, are equally effective in controlling post-operative pain
详细描述
Open label, observer and patient blinded randomized control study of patients age 18 to 85 who are booked to have an open upper abdominal surgical incision where an epidural would normally be offered and expected to be used for an average of 4 to 5 days.
Study will be done at University of Iowa Hospitals and Clinics main operating room and post-operative surgical wards.
Eligible patients who choose to consent to participate in the study will be randomized to either have the opioid administered intravenously using patient controlled administration (PCA) device along with a local anesthetic only continuous epidural infusion ,the control group, or to the treatment group of the opioid combined with the local anesthetic in the epidural with a continuous infusion combined with patient controlled epidural administered (PCEA) bolus. The epidural pump along with the PCA machine will be placed in such away that they can be obscured by a removable cover. The patient will be seen daily to obtain pain and satisfaction scores using the Quality of Recovery (QoR) 15. Secondary data will also be collected including presence of side effects, ability to mobilize, signs of return of bowel function, need for supplemental oxygen and total amount of opioid required. Patients will be assigned a study number, which all data will be kept under.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Patient and bedside observer will be blinded to which group the patient is in
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age including and between 18 to 85 years old
- •Planned open abdominal procedure with an incision that is or includes above the umbilicus, where epidural would normally be offered and epidural would be maintained for an average of 4 to 5 days
- •Patient has consented for an epidural
- •Patient is able to converse in English
- •Patient is able to use a patient controlled pump
排除标准
- •Has a known contraindication for an epidural
- •Known mental or cognitive disability
- •History of chronic opioid use or substance abuse disorder
- •Pre-operative use of opioids
- •History of chronic pain
- •Routine use of marijuana
- •Incarcerated
- •Unable to converse in English
- •Planned to remain intubated post-operatively
- •Need for post-operative use of anticoagulant regiment that would be contraindicated with an indwelling epidural catheter
- •End stage renal disease or dialysis
- •Hepatic disease that affects metabolism of drugs
- •Known contraindication to any of the study drugs
- •Known pregnancy or positive pre-operative pregnancy test
- •Known neurological condition that may affect motor or sensory systems
研究组 & 干预措施
Control
Hydromorphone administered intravenous PCA combined with a continuous bupivacaine epidural infusion
干预措施: Intravenous administered opioid (Drug)
Treatment
Hydromorphone combined with bupivacaine in the epidural and administered as a continuous infusion with a PCEA bolus as necessary
干预措施: Epidural administered opioid (Drug)
结局指标
主要结局
With a local anesthetic epidural, is the epidural administration of opioids similar to opioids administered by intravenous
时间窗: Once daily until one day after the epidural in discontinued which would mean a maximum of 8 days post-operatively
Quality of Recovery (QoR) 15 score from 0-150 with the higher the score the better
次要结局
- With a local anesthetic epidural, are there any differences in the incidence of opioid side effects between intravenous and epidural administered opioids(Assessed daily until the epidural is removed, which is maximum of 7 days post-operatively)
- Does the route of epidural opioid administration, intravenous vs epidural, affect the return of bowel function(daily assessment until epidural removed, which is a maximum of 7 days post-operatively)
- Does the route of epidural opioid administration, intravenous vs epidural, impact patient ability to be discharged(Will follow until patient discharged or maximum 10 days post-operatively)
研究者
Melinda Seering
Clinical Associate Professor
University of Iowa