The Opioid Sparing Effect of an Inter-semispinalis Plane Block on Postoperative Pain Control in Posterior Cervical Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Lower opioid use
研究概览
简要总结
Participants who have a surgical procedure called Posterior Cervical (neck) Spine Surgery will normally need pain medication to relieve post operative pain. This usually includes opioid medications. In this study, the consented participant may receive a nerve block procedure, in addition to the pain relieving medication. There is a fifty-fifty chance to receive the nerve block. The goal is to see if the nerve block group needs less opioid medication, has lower pain scores and is discharged from the hospital sooner.
详细描述
The purpose of this research study is to evaluate the opioid-sparing effect of the use of an Inter-semispinalis plane (ISP) block after posterior cervical spine surgery.
Posterior cervical fusion (PCF) is a painful procedure that often requires the use of high doses of opioids to minimize postoperative pain. Uncontrolled pain can result in a delay in recovery and discharge. Additionally, high doses of opioids carry the risk of opioid dependence, and other side effects, include nausea, vomiting, sedation, and, in rare cases, respiratory depression. For all of the above reasons, reducing the use of opioids is of utmost importance.
Nerve blocks are one alternative to opioid use. The ISP block is a procedure described in 2017; it is a relatively simple procedure that entails injecting local anesthetic between two muscles in the back of the neck, bilaterally, to block the nerves that run in this plane. It is done under ultrasound guidance and, although a limited number of studies have shown promise, more data on its safety and efficacy are needed. The addition of Dexamethasone to local anesthetics, in nerve blocks, resulted in significant prolongation of the analgesia.
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
- Single (Participant)
盲法说明
Participants will be randomized using REDCap software. If the participant is randomized to the ISP Block group, it will be completed after the participant has been administered General Anesthesia and prior to surgery start.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having Posterior Cervical Spine Surgery from C2 - C7, which may extend to the upper thoracic vertebrae, inclusive to T
- •Capacity to provide informed consent
排除标准
- •Fusion and decompression due to trauma
- •Emergent procedures
- •Patient is on a medication-assisted treatment, e.g., buprenorphine, naltrexone or methadone.
- •There is an infection near or in the area of neck where the block will be placed.
- •The patient is having a complicated surgery or a revision surgery
- •Female patient with a positive pregnancy test on the day of surgery (hospital standard-of-care).
- •Patient has Diabetes
- •Patients who have had a prior adverse reaction to bupivacaine or dexamethasone
- •Patients with Glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methemoglobinemia
研究组 & 干预措施
Routine Pain Management
Routine Pain Management will include standard of care pharmacological management, by using patient-controlled opioid analgesia, oral acetaminophen, intravenous Ketorolac (Toradol), and Gabapentin. As needed (PRN), Intravenous hydromorphone will be given for breakthrough pain.
干预措施: Opioids (Drug)
Routine Pain Management plus an Inter-semispinalis Plane Block
Routine Pain Management, as described above, plus and ISP Block. After general anesthesia has begun, in the operating room, and the patient is moved to the prone position, before surgery start, those patients who are randomized to the block group, will receive a bilateral ISP nerve block in the back of the neck under ultrasound guidance, by a qualified, experienced Anesthesiologist.
Under complete aseptic technique using an ultrasound guidance, 20 ml of Bupivacaine 0.25 % with 2 mg of Dexamethasone will be injected between two muscles in the back of the neck, bilaterally, to block the nerves that run in this plane.
Once the block is completed, the surgical procedure will proceed as usual.
干预措施: Inter-semispinalis Plane Block (Procedure)
结局指标
主要结局
Lower opioid use
时间窗: 48 hours post Post-Anaesthesia Care Unit (PACU) arrival time
Comparison of the reduction in Morphine Milligram Equivalent (MME) dose of opioids consumed between the control group versus the nerve block group.
次要结局
- Pain Scores(48 hours after PACU arrival time)
- Lower opioid use.(MME use will be recorded from the patient's Anesthesia induction time until the patient's PACU arrival time. This will be the intra-operative period, which may last several hours, but not expected to exceed eight hours.)
- Lower opioid use(24 hours after PACU arrival time)
- Length of hospital stay(The patient's EMR will record the date and time of admission, as well as, the date and time of discharge. This will be quantified by the REDCap software being used for this study, and is not expected to exceed four days.)
研究者
Eman Nada
Chief of Regional Anesthesia
Stony Brook University