A Comparison of 0.1 and 0.2% Ropivacaine in Lumbar Plexus Catheters After Primary Total Hip Arthroplasty: a Comparison of Postoperative Analgesia and Motor Function.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Opiate Consumption Postoperatively
研究概览
简要总结
Peripheral nerve blocks are the standard of care for pain management after hip replacement surgery at UPMC Shadyside. This prospective, randomized study is intended to assess the effect of 0.1 versus 0.2% ropivacaine in lumbar plexus nerve catheter infusions after total hip arthroplasty. Ropivacaine peripheral nerve block infusions have been utilized as the standard of care at UPMC Shadyside for many years. Ropivacaine, a less potent left-isomer of bupivacaine, is often used in place of bupivacaine due to less motor blockade and less severe cardiovascular and central nervous system potential toxicity.
The primary goal of this study to examine the effect of a low concentration infusion of ropivacaine (0.1%) on postoperative analgesia (evaluated by opioid consumption after 36 hours) compared with the standard accepted concentration of 0.2% ropivacaine in lumbar plexus catheters after primary total hip arthroplasty. Secondary goals are to examine motor function, VAS scores and patient satisfaction with pain control in low concentration 0.1% ropivacaine compared with 0.2% ropivacaine lumbar plexus infusions upto 36 hours after primary total hip arthroplasty.
详细描述
Lumbar plexus catheters are the standard of care for postoperative pain management following total hip arthroplasty (THA) at UPMC Shadyside. The safety and efficacy of this technique has been demonstrated by multiple studies. Ropivacaine 0.2% was used for many years at UPMC Shadyside and throughout the UPMC system and this concentration of ropivacaine is the standard local anesthetic utilized by multiple other studies. However, this concentration of ropivacaine was later decreased to 0.1% in our institution in order to decrease patient's motor weakness and promote postoperative physical therapy. Patients were clinically observed to continue to have adequate postoperative analgesia while demonstrating improved motor function. A randomized, double blinded clinical trial has never compared 0.1 and 0.2% ropivacaine.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years old
- •American Society of Anesthesiologists physical status score I-III
- •Scheduled for primary total hip arthroplasty at UPMC Shadyside Hospital in Pittsburgh, PA.
- •No contraindications to peripheral nerve catheter placement
- •Patients not expected to receive therapeutic anticoagulation in the postoperative period.
- •No known drug allergies to study medications
- •Patients willing to receive spinal anesthesia as operative anesthetic
排除标准
- •Age under 18 years or older than 75 years.
- •Any contraindication to a placement of continuous lumbar plexus peripheral nerve catheter.
- •American Society of Anesthesiologist physical status IV or greater.
- •Chronic painful conditions.
- •Preoperative opioid tolerant use (opioid use for greater than 6 contiguous months before surgery).
- •Coagulation abnormalities or patients who are expected to be on therapeutic anticoagulants postoperatively.
- •Allergy to any of the drugs/agents used study protocol.
- •Pregnancy
- •Having an altered mental status (not oriented to place, person, or time)
- •Any comorbid condition that, in the judgment of the consulting orthopedic surgeon or intraoperative anesthesiologist, would proscribe the patient from any aspect of the study.
- •Patient refusal.
- •Patient requiring postoperative management in the ICU
- •Lumbar plexus catheter placed by loss of resistance technique.
研究组 & 干预措施
0.2% ropivacaine nerve block (standard of care)
0.2% ropivacaine in lumbar plexus nerve catheter infusions for postoperative analgesia
干预措施: 0.1% or 0.2% ropivacaine nerve blocks (Drug)
0.1% ropivacaine infusion in nerve block catheter
0.1% ropivacaine in lumbar plexus nerve catheter infusions
干预措施: 0.1% or 0.2% ropivacaine nerve blocks (Drug)
结局指标
主要结局
Opiate Consumption Postoperatively
时间窗: 24 hours postoperatively
Postoperative opiate consumption at 24 hours
次要结局
- Patient Satisfaction With Pain Control(24 hours postoperatively)
- Numeric Rating Scale Pain Score With Movement at 24 Hours(24 hours postoperatively)
- Number of Participants With Increased Infusion Rates(Subjects will be followed postoperatively until postoperative day 2 (i.e. the discontinuation of the lumbar plexus catheters))
- Number of Participants With Decreased Infusion Rates(Subjects will be followed postoperatively until postoperative day 2 (i.e. the discontinuation of the lumbar plexus catheters))
研究者
Sylvia Wilson
Regional Anesthesia Fellow
University of Pittsburgh