Continuous Erector Spinae Block for Analgesia Following Lumbar Decompression: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Numeric rating scale (NRS)
研究概览
简要总结
Lumbar spinal surgery is common, and the incidence of spinal fusion has increased dramatically over the past three decades. Patients requiring spinal surgery are typically prescribed several analgesics, (including opioids) while awaiting surgery. Postoperatively, use of high doses of opioids or anti-inflammatory medications have drawbacks. Severe post-operative pain is reported by 45-80% of patients and rates are generally higher in the opioid tolerant patients.
Regional anesthesia (blocking nerves with local anesthetics) works locally, thereby avoiding many side effects associated with other analgesics. One type of nerve block is called erector spinae plane block (ESP). Single injection nerve blocks have been found to decrease pain, nausea, and opioid consumption, while increasing patient satisfaction and quality of recovery. However, these effects only last for 24 hours or less while the worst pain occurs around 36 hours after surgery. Surgeon-placed indwelling catheters could allow infusions of local anesthetics for 54 hours.
This randomized control trial seeks to assess the effectiveness of surgeon-placed ESP catheters for pain control after lumbar spine surgery.
Hypothesis: Patients receiving a cESP will have less pain, improved quality of recovery, and opioid use following lumbar fusion surgery than those receiving current standard of care pain management.
Methodology: Adult patients undergoing lumbar spine surgery under orthopedic surgery in Halifax will be eligible. The study will include 100 participants, randomly assigned to 2 study arms of 50 participants (1:1 basis to Ropivacaine and placebo groups). At the end of surgery, the surgeon will place the ESP catheters in all study patients under sterile conditions before closing the wound. Ropivacaine 0.5% or normal saline (placebo) 15ml will be injected through each catheter (total 30ml). In the postanesthetic care unit (PACU), two elastomeric pumps will be attached to the ESP catheters. These will be filled with either Ropivacaine 0.2% or normal saline (placebo). The elastomeric pumps are small bottle that patients can carry with them after discharge home. The pumps automatically run at an infusion rate of 10 ml/hr for 54 hours. All patients will also receive the standard of care for pain management for this patient population, which is opioid based with acetaminophen. A quality of recovery (QoR-15) questionnaire will be completed at 72 hours post-operatively. Pain, catheter complication, and opioid use data will be gathered from the patient's charts at 24, 48, and 72 hours post-operatively. At 3- and 6-month follow-ups, patients will complete the Brief Pain Inventory questionnaire. We will analyze differences in pain and opioid consumption at 24, 48, and 72 hours, quality of recovery index scores at 72 hours, postoperative complication rates, and persistent pain at 3 and 6 months.
详细描述
Hypothesis Our hypothesis is that a continuous erector spinae plane block (cESP) is an effective postoperative analgesia for lumbar decompression and interbody fusion patients.
Primary Study Objective To compare pain scores as measured by numeric rating scale (NRS) at 24 hours between continuous erector spinae plane block (cESP) and standard of care with placebo following lumbar fusion surgery.
Main Study Objectives
- To compare the quality of recovery (QoR-15) at 72 hours for patients with a cESP with ropivacaine versus placebo.
- To compare cumulative opioid consumption (in oral morphine equivalents (OME)) between cESP and placebo groups.
- To compare time to discharge from hospital between cESP and placebo groups.
- To compare adverse events between cESP and placebo groups.
- To compare persistent postsurgical pain (PSPP) at 3 months between cESP and placebo.
1. Research Plan Subject Selection, Inclusion/exclusion criteria This study will include patients undergoing lumbar decompression and lumbar interbody fusion surgery under orthopedic surgery at the QEII Health Sciences Center in Halifax, Nova Scotia.
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
The Nova Scotia Health (NSH) pharmacy will prepare either Ropivacaine or normal saline in identical elastomeric pumps labelled as "study drug" such that the patient, clinical staff and the researchers are blinded to assigned group. The pharmacy will maintain the assignment list, only unmasking assignment in cases of suspected local anesthetic systemic toxicity (LAST) or allergic reactions.
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
- •Adult (aged >18 years) patients
- •Undergoing lumbar decompression surgery +/- fusion
- •Under the orthopedic surgery team
排除标准
- •Surgery on an emergency basis (level 1, 2 or 3; <8 hours)
- •An ejection fraction <30%
- •Severe pre-existing liver disease (Child B or C)
- •Severe kidney disease (Glomerular filtration rate (GFR) <30 (mL/min/1·73m²))
- •An allergy to ropivacaine
- •Weight <50 kg
- •Unable to provide valid consent to study prior to surgery
研究组 & 干预措施
Erector spinae plane catheter with Ropivacaine
All study patients will have two catheters inserted during surgery (i.e. on either side of the spinal cord), but patients in this arm will receive Ropivacaine through the cathedars in addition to normal medications for post-operative pain.
干预措施: Continuous erector spinae plane block (Procedure)
Erector spinae plane catheter with normal saline
All study patients will have two catheters inserted during surgery (i.e. on either side of the spinal cord), but patients in this arm will receive normal saline (placebo) through the cathedars in addition to normal medications for post-operative pain.
干预措施: Continuous erector spinae plane block (Procedure)
结局指标
主要结局
Numeric rating scale (NRS)
时间窗: 24 hours
Patient rate pain level according to a numbered scale (0-10 with worse pain being rated higher).
次要结局
- Quality of recovery (QoR-15)(72 hours)
- Cumulative opioid consumption (in oral morphine equivalents (OME))(72 hours)
- Time to discharge from hospital(Up to 30 days)
- Adverse events(30 days)
- Persistent postsurgical pain (PSPP)(3 months and 6 months)
