Hyperalgesia, Persistent Pain, and Fentanyl Dosing in On-Pump Coronary Artery Bypass Grafting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Area of hyperalgesia at 24h
研究概览
简要总结
Randomized, double-blinded, three arm study in adult patients undergoing first time coronary artery bypass grafting (CABG) surgery with median sternotomy. The investigators will examine the effects of three fentanyl dosing schemes (high-dose bolus, low-dose bolus, continuous dose) on the area of hyperalgesia and allodynia at 24 and 48h as well as on persisting pain at 3, 6, and 12 months. Additionally, the investigators will measure fentanyl concentrations throughout anesthesia.
详细描述
A prospective, randomized, double-blinded (patient, anesthesiologist, assessor) clinical study. This study will examine three different clinically used application schemes of fentanyl, an opioid used as the standard of care in routine practice. Patients will be randomized to receive one of the following three treatment arms for anesthesia maintenance (pre-sternotomy):
- High-dose fentanyl bolus (20 µg/kg of body weight [BW]; e.g. 70kg 1400 µg or 1.4mg)
- Low-dose fentanyl bolus (3 µg/kg BW; e.g. 70kg 210 µg or 0.2mg)
- Continuous fentanyl application by Shibutani scheme
This study will include data from 69 adult patients (23 per arm) undergoing first time, elective, on-pump CABG surgery with median sternotomy and central cannulation.
Following randomization by the sealed envelope technique, fentanyl kits will be drawn up by an anesthesiologist not involved in patient care or outcome assessment. Patients with preexisting chronic pain, opioids in the last 30 days, a BMI>36kg/m2, sleep apnoea, renal failure (clearance <30ml/min), with neuraxial anesthesia, pregnant, with planned wound infiltration, known allergies/intolerance to opioids, and unable to understand pin-prick testing will be excluded.
At induction, all patients will receive a standard 3 µg/kg bolus of fentanyl (not study medication, but rather standard of care). 5 minutes prior to sternotomy, the patient will receive analgesia maintenance (one of the three fentanyl study arms). Clinicians will at all times be able to administer a bolus of fentanyl on a perceived "as needed" basis (not study medication, but rather standard of care).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Only an otherwise uninvolved anesthesiologist will know dosing schemes.
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
- •Consenting patients aged ≥18 years
- •Undergoing first-time, elective, on-pump CABG surgery with median sternotomy and central cannulation.
排除标准
- •Documentation of preexisting chronic pain as per electronic record
- •Use of opioids in the last 30 days or history/documentation of opioid abuse as per electronic record
- •BMI > 35kg/m2 or history of obstructive sleep apnea syndrome
- •Patients with renal failure (clearance < 30 ml/min)
- •Neuraxial anesthesia
- •Pregnancy
- •Planned wound infiltration with local anesthetics
- •Known drug allergies or intolerance to fentanyl or other opioids
- •Expected to be unable to understand pinprick/allodynia testing / follow-up questions
研究组 & 干预措施
High-Dose Bolus of Fentanyl
5 minutes prior to sternotomy, patients will receive a fentanyl bolus of 20 mcg/kg BW (verum) and a perfusion pump with sodium chloride (NaCl 0.9%; placebo) will be begun according to the Shibutani dosing scheme.
As in the other arms, patients will be induced with 3mcg/kg BW fentanyl and the treating physician may administer boli on an "as needed" basis.
干预措施: Fentanyl dosing schemes (Drug)
Low-Dose Bolus of Fentanyl
5 minutes prior to sternotomy, patients will receive a fentanyl bolus of 3 mcg/kg BW (verum) and a perfusion pump with sodium chloride (NaCl 0.9%; placebo) will be begun according to the Shibutani dosing scheme.
As in the other arms, patients will be induced with 3mcg/kg BW fentanyl and the treating physician may administer boli on an "as needed" basis.
干预措施: Fentanyl dosing schemes (Drug)
Continuous Dose of Fentanyl
5 minutes prior to sternotomy, patients will receive a NaCl 0.9% bolus (placebo) and a perfusion pump with fentanyl (verum) will be begun according to the Shibutani dosing scheme.
As in the other arms, patients will be induced with 3mcg/kg BW fentanyl and the treating physician may administer boli on an "as needed" basis.
干预措施: Fentanyl dosing schemes (Drug)
结局指标
主要结局
Area of hyperalgesia at 24h
时间窗: 24 hours after surgery (+/- 3 hours)
Determination of secondary, wound hyperalgesia by pin prick (256mN von Frey filament)
次要结局
- Description of perioperative fentanyl concentrations with on-pump extra corporeal circulation(end of surgery (+/- 5 min))
- Area of allodynia at 24h(24 hours after surgery (+/- 3 hours))
- Persistent Pain at 12 months(12 months after surgery (+/- 1 week))
- Area of hyperalgesia at 48h(48 hours after surgery (+/- 3 hours))
- Persistent Pain at 6 months(6 months after surgery (+/- 1 week))
- Area of allodynia at 48h(48 hours after surgery (+/- 3 hours))
- Persistent Pain at 3 months(3 months after surgery (+/- 1 week))
