Pain Management in Cardiac Implantable Electronic Device Insertion; Effectiveness of Bupivacaine, Ketorolac, Ketamine, vs Bupivacaine Alone in Reducing Postoperative Pocket Pain
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Comparative efficacy/superiority of BKK compared to bupivacaine alone in providing comfort
研究概览
简要总结
Bupivacaine is the most widely used local anesthetic agent across majority of the Cardiac Implantable Electronic device (CIED) implant procedures in the United States. It is hypothesized that the combination of Bupivacaine-Ketorolac-Ketamine (BKK) is more effective in alleviating perioperative and postoperative pain as compared to the use of bupivacaine alone.
A few studies have been done to look for the effectiveness of BKK in abdominal surgical procedures. However, no study has been done to evaluate its efficacy and effectiveness in patients undergoing CIED insertion.
详细描述
Bupivacaine is a widely used local anesthetic and is often administered by spinal injection prior to major surgical procedures. Ketorolac is a potent NSAID which is used for the short-term relief of moderate to severe pain. It's used for long term duration is generally limited due to its potential to cause GI ulcers/perforation and renal failure. A single dose of perioperative Ketorolac has been found to be effective in reducing opioid consumption. Ketamine is NMDA receptor antagonist and is used for its anesthetic, analgesic, and psychotomimetic effects. It is primarily used for induction and maintenance of anesthesia and induces a trance like state providing pain relief, sedation, and amnesia.
Although an effective local anesthetic agent, bupivacaine has weak analgesic effect and is used in combination with several analgesic agents for effective perioperative and postoperative analgesia. A common drug used in this analgesic regimen usually includes opioids such as morphine, oxycodone, and fentanyl. Over the last few decades the United States has witnessed an opioid epidemic and post-surgical opioid prescription is one of the major contributors of this epidemic. An opioid free combination of Bupivacaine-Ketorolac-Ketamine (BKK) is thought to be effective in alleviating perioperative and postoperative pain.
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
- 是
入选标准
- •Both male and female patients
- •Patients older than 18 years of age
- •Patients undergoing new CIED (ICD, pacemaker, CRT-D or CRT-P)
- •Patients willing to participate in the study
排除标准
- •Patients with prior history of allergic reaction to any component of the drug; bupivacaine, ketorolac, or ketamine
- •Pregnant or breastfeeding patients
- •Prisoners
- •Patients younger than 18 years of age
- •Patients not willing to participate in the study
- •Patients deemed not suitable or unstable for the study as per physician's discretion
研究组 & 干预措施
Bupivacaine Alone
This is the control group of patients receiving 20 cc of 0.5% bupivacaine (Bupivacaine HCL 100 mg [5mg/ml] alone. The dose and number of doses of the medicines will be adjusted as per discretion of the operator.
干预措施: Bupivacaine alone OR Bupivacaine-Ketorolac-Ketamine (BKK) Combination (Drug)
Bupivacaine-Ketorolac-Ketamine (BKK) Combination
This is the intervention group of patients receiving 20 cc combination of BKK (Bupivacaine HCl 60 mg [3 mg/mL], Ketorolac Tromethamine 24 mg [1.2mg/mL], Ketamine HCl 24 mg [1.2 mg/mL]).The dose and number of doses of the medicines will be adjusted as per discretion of the operator.
干预措施: Bupivacaine alone OR Bupivacaine-Ketorolac-Ketamine (BKK) Combination (Drug)
结局指标
主要结局
Comparative efficacy/superiority of BKK compared to bupivacaine alone in providing comfort
时间窗: Upto 1 week
The goal of this prospective open label study is to demonstrate a comparative efficacy/superiority of BKK compared to bupivacaine alone in providing comfort. Patient's comfort will be assessed using a verbal rating score either through a telephone call from the research team or via clinic follow-up visit. The comfort score determines patients comfort from 0 to 100 with 0 indicating extremely uncomfortable (Worse outcome) and 100 indicating extremely comfortable (Better outcome).
Comparative efficacy/superiority of BKK compared to bupivacaine alone in Quality of Life (QoL)
时间窗: Upto 1 week
The goal of this prospective open label study is to demonstrate a comparative efficacy/superiority of BKK compared to bupivacaine alone in Quality of Life. Patient's Quality of Life will be assessed using a QoL score (EQ5-5D-5L) either through a telephone call from the research team or via clinic follow-up visit. The Quality of life questionnaire (EQ-5D-5L) has five response levels : no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5), with low values suggesting better outcomes and higher values suggesting worse outcomes.
Comparative efficacy/superiority of BKK compared to bupivacaine alone in reducing the pain intensity
时间窗: Upto 1 week
The goal of this prospective open label study is to demonstrate a comparative efficacy/superiority of BKK compared to bupivacaine alone in reducing the pain intensity. Patient's pain will be assessed using a Visual Analog Scale either through a telephone call from the research team or via clinic follow-up visit. The visual analog scale (VAS) determines pain from 0 to 10 with 0 indicating no pain (Better outcome) and 10 indicating worse pain in their life indicating (worse outcome).
次要结局
- Hospital readmission rates(Until 7 days (Until the end of the sutdy))
- Adverse Effects(Until 7 days (Until the end of the sutdy))
- Amount of pain medication used(Upto 1 week)
- Cost comparison of medications(Upto 1 week)