Bilateral Paravertebral Blockade for Improvement of Quality of Recovery Following Cardiac Surgery (P-QOR): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Initial Quality of Recover-15 (QoR-15) score
研究概览
简要总结
This study aims to evaluate the efficacy of bilateral, paravertebral blockade (intervention) against sham blocks (control) placed prior to sternotomy in improving quality of recovery following cardiac surgery.
Primary outcome: The hypothesis is that bilateral single-shot PVB at the thoracic spinal segmental levels T3/4, compared with sham blocks, improve the Quality of Recovery-15 (QoR-15) score at 24 hours following cardiac surgery by a minimally clinically important difference of 8.0 or greater.
Secondary outcomes: The hypothesis is that the intervention will reduce pain scores, opioid requirements, and related side effects; improve respiratory mechanics; and facilitate a better first night's rest/sleep in the first 24-48 hours compared to sham blocks.
详细描述
This will be a triple-blinded, individually-randomized, single-centered, placebo-controlled trial in which patients will be randomly allocated to two study groups in a 1:1 ratio.
Randomization: The investigators will randomize patients in blocks of 4 or 6. The randomization sequence will be generated online using Sealed Envelope (sealedenvelope.com) . Allocation to treatment versus control will be placed in sealed envelopes. The envelopes will be sequentially numbered, signed and opaque, with the randomization group insert wrapped in foil, and further blocked by carbon paper. On the day of surgery, the regional anesthesiologist be provided the envelope by the research assistant. They will to open it in private, and then destroy its contents immediately upon reading the allocation card.
This study observes blinding of the patients, anesthesiologists, surgeons, nurses, outcome collectors, and data analysts. Only the regional anesthesiologist performing the intervention will be unblinded. To preserve blinding for everyone else, only the regional anesthesiologist and anesthesia assistant will be present in the room at the time of block. Windows on the operating room doors will be covered and a sign mounted to limit entry unless there is an emergency.
Eligible patients will be identified in the Pre-assessment Clinic (PAC) or the inpatient ward. Potentially eligible participants will be screened for significant cognitive impairment, and those scoring 1-2 on the Mini-Cog will be excluded. Enrolled patients will complete a baseline QoR-15 survey. Patients will then be provided a study information package which they can then review on their own time. On the day of surgery, the unblinded regional anesthesiologist will receive information on patient allocation from sealedenvelopes.com and perform the study procedure in the operating room with arterial line monitoring prior to induction of anesthesia. anesthesiologist.
Patients will remain intubated following surgery and be transferred to the CSICU where they are usually extubated within 4-6 hours. Following extubation, patients will receive pain management using hydromorphone IV until transfer to the ward or for the first 24 hours (whichever comes first). For the remainder of the study, the patient will be prescribed a standard postoperative pain control regimen and management will be at the discretion of attending CSICU intensivist, cardiac surgeon or nurse practitioner without influence from this study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study observes blinding of the patients, anesthesiologists, surgeons, nurses, outcome collectors, and data analysts. Only the regional anesthesiologist performing the intervention will be unblinded. To maintain the quality and legitimacy of the trial, unblinding may only occur if knowledge of the actual intervention is essential to treat and manage the patient. In events such as acute and limited episode of hypotension or bradycardia from a vasovagal event, blinding will be maintained as knowledge of intervention is not required for management. All code breaks with reason will be documented and reported. A protocol description of conditions and procedures for emergency unblinding will be drafted, but the ultimate decision at the time of the block will be at the discretion of the regional anesthesiologist.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult (19 years or older)
- •English-speaking patients
- •Scheduled for elective cardiac surgery with full median sternotomy.
排除标准
- •Patient refusal, inability to provide consent
- •Mini-Cog© Score of 1-2
- •emergent surgery
- •infection at the site of injection
- •neoplastic mass in the paravertebral space
- •known preoperative coagulopathy
- •platelet count < 50 x 109, INR or aPTT exceeding the upper range of normal in the absence of anticoagulant use, patients receiving anticoagulation medications or non-ASA anti-platelet medications that have not been stopped for the appropriate duration in accordance with American Society of Regional Anesthesia and Pain Medicine guidelines (20)
- •severe kyphoscoliosis or deformed spines or previous thoracic surgery
- •allergy to study medications
- •preoperative liver failure (as defined by Child-Pugh B or C)
- •chronic pain or opioid use history, alcohol or drug use disorders, major psychiatric or neurodevelopmental disorders
- •Moderate to severe pain at baseline.
- •preoperative renal failure (as defined by eGFR < 30 mL/min/1.73 m2)
- •extremes of weight (BMI > 40 kg/m2, and weight < 50 kg)
- •Patients anticipated to require prolonged post-operative ventilation > 24 hours after surgery
- •High risk by Euroscore II >=8%) (21-23)
- •3 or more major procedures
- •Procedures requiring deep hypothermic circulatory arrest (DHCA)
研究组 & 干预措施
Intervention Group
Bilateral, single level, paravertebral blockade with 0.25% ropivicaine
干预措施: Bilateral paravertebral block with 0.25% ropivicaine with 1:400,000 epinephrine (Procedure)
Control Group
Bilateral, single level, subcutaneous sham block with normal saline
干预措施: Bilateral sham block with normal saline (Procedure)
结局指标
主要结局
Initial Quality of Recover-15 (QoR-15) score
时间窗: 24 hours following the intervention
The QoR-15 score is a validated tool used to assess the quality of recovery at 24 hours. following the intervention. This score ranges from 0 to 150, with higher scores indicating higher quality of recovery.
次要结局
- Cardiac Surgery Intensive Care unit length of stay(Up to time of hospital discharge or 14 days post-operatively, whichever is sooner.)
- Incidence of new onset post-operative atrial fibrillation(Up to 48 hours following surgery)
- Hospital length of stay(Up to time of hospital discharge or 14 days post-operatively, whichever is sooner.)
- Subsequent Quality of Recovery-15 (QoR-15) scores(48 hours following surgery and 12 weeks following surgery)
- Quality of sleep(24 hours and 48 hours following surgery)
- Opioid consumption(24 hours and 48 hours following surgery)
- Pain scores(every 4 hours for the first 24 hours then every 8 hours until the 48 hour mark following surgery)
- Severity of post-operative nausea and vomiting(24 hours and 48 hours following surgery.)
- Duration of post-operative mechanical ventilation(Up to time of hospital discharge or 14 days post-operatively, whichever is sooner.)
- Incidence of pulmonary complications(24 hours and 48 hours following surgery)
- Incidence of new onset delirium during hospital stay(Up to time of hospital discharge or 14 days post-operatively, whichever is sooner.)
- Incidence of hospital or ventilator acquired pneumonia during hospital stay(Up to time of hospital discharge or 14 days post-operatively, whichever is sooner.)
研究者
Terri Sun
Clinical Assistant Professor
University of British Columbia