Randomized Study Of Cranial Blocks For Postoperative Anesthesia To Reduce Pain And Postoperative Opioid Usage
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale
研究概览
简要总结
This study compares the standard of care to the standard of care plus the administration of bupivacaine or liposomal bupivacaine in patients receiving craniotomies.
详细描述
Objective
To assess the effectiveness of analgesia by scalp nerve block with various agents in the first 72 hours following elective craniotomy.
The investigators will employ a randomized, single-blinded, prospective study design. Participants will be randomized 1:1:1 into one of three treatment groups: Bupivacaine, Liposomal Bupivacaine, and Saline.
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
- Double (Participant, Care Provider)
盲法说明
On the morning of the procedure, participants will be assigned sequentially to the lowest unassigned randomization number. The surgeon performing the procedure and operating room staff will not be blinded to the intervention, since they will see whether the patient is receiving liposomal bupivacaine, bupivacaine or saline. However, all providers obtaining post-operative data from the patients will be blinded as to which treatment the patient received, in addition to the patient themselves.
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
- •≥18 years of age
- •Need for elective supratentorial craniotomy
- •Preoperative GCS > 13
排除标准
- •Preoperative GCS ≤ 13
- •Child (<18 years of age)
- •Inability to understand or use the visual analog scale (VAS)
- •Proven or suspected allergy to local anesthetics
- •Craniotomy incision extending beyond the field of the block
- •Patients chronically (more than 2 wk) treated with narcotic medications
- •Previous scalp incision
- •Bilateral craniotomies
- •Allergies to local anesthetics
- •GCS verbal score < 4 after extubation
- •Patients whose surgeries extend past 6 hours (will be placed on standard of care and removed from study)
- •Patients currently on ergot-type oxytoxic drugs, MAOIs, or certain antidepressants
- •Lactating Mothers
研究组 & 干预措施
Saline group
The surgeon will administer injectable saline as a cranial block. The supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, postauricular lesser and greater occipital nerve branches on the ipsilateral side of the operation will be blocked with 5-10 cc of solution (with a maximum of 60 cc at all sites) by needle infiltration. This process generally takes 1-2 minutes. Following this, the general anesthesia is lightened and the patient is extubated in usual fashion.
干预措施: Saline (Drug)
Liposomal Bupivacaine
The surgeon will administer Exparel (liposomal bupivacine) as a cranial block. 20 mL of Exparel will be diluted with saline to constitute 60 mL total. The supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, postauricular lesser and greater occipital nerve branches on the ipsilateral side of the operation will be blocked with 5-10 cc of solution (with a maximum of 60 cc at all sites) by needle infiltration. This process generally takes 1-2 minutes. Following this, the general anesthesia is lightened and the patient is extubated in usual fashion.
干预措施: Liposomal bupivacaine (Drug)
Bupivacaine
The surgeon will administer bupivacaine as a cranial block. The supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, postauricular lesser and greater occipital nerve branches on the ipsilateral side of the operation will be blocked with 5-10 cc of solution (with a maximum of 60 cc at all sites) by needle infiltration. This process generally takes 1-2 minutes. Following this, the general anesthesia is lightened and the patient is extubated in usual fashion.
干预措施: Bupivacaine Injection (Drug)
结局指标
主要结局
Visual Analogue Scale
时间窗: 10 months (study terminated prior to completion)
The Visual Analogue Scale (VAS) is a straight, horizontal line of fixed length, numbered 0 to 10 as a measure of pain severity. The ends are the extreme limits of this scale, with the left side (0) representing the best outcome (no pain), and the right side (10) representing the worst outcome, extreme pain. The other numbers in between are representations of the variation in pain between these two feelings. The scale is presented to the participant with a verbal explanation of its meaning, and the participant points to or states a number indicating where they feel their pain level is best represented on the scale. That number is recorded. For each group, every participant reported several different pain scores over multiple hours. The averages (means) below represent the summation of all of the pain scores reported throughout their admission.
次要结局
- Length of Stay (ICU and(10 months (study terminated))
研究者
Timothy Lucas, MD, PHD, MHCI
Primary Investigator
University of Pennsylvania