A Prospective, Randomized Trial of Liposomal Bupivacaine Compared to Continuous Nerve Catheters on Pain Control and Post-Operative Opioid Use in Receiving Popliteal Nerve Blocks for Below the Knee Amputation
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Pain Assessed by Numerical Rating Scale (NRS)
研究概览
简要总结
Through this pilot prospective trial, we aim to obtain preliminary data investigating the effectiveness of perineural catheters and liposomal bupivacaine, both currently accepted as standard care at Maine Medical Center, for the management of post-limb amputation pain. We will use the data that we collect to inform the design of a larger, appropriately powered study.
详细描述
Lower extremity amputation is a common surgical procedure often due to limb ischemia or complications related to diabetes mellitus. Managing postoperative pain can be quite challenging in this patient population and persistent post-surgical pain is not uncommon. Peripheral nerve catheters (PNCs) that deliver a continuous infusion of local anesthetic have been shown to provide analgesic benefit dependent upon infusion duration and in the absence of catheter malfunction. Unfortunately, PNCs can be difficult to place and rates of dislodgement are estimated at 30%. Single shot regional nerve blocks using liposomal bupivacaine are much easier to perform than PNCs and can provide up to 72 hours of pain relief, eliminating the need for catheter placement. To date, no study has investigated the effects of liposomal bupivacaine compared to PNCs for post-surgical pain control. In this pilot study, we intend to compare pain scores, opioid consumption, and length of stay in patients randomized to both treatment strategies. We also intend to conduct an exploratory analysis investigating incidence of phantom limb pain one month following surgery. Our results will inform the design of a larger powered study to investigate treatment effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
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
- •American Society of Anesthesiologists Physical Status Classification I-IV
- •Scheduled for primary amputation or stump revision
- •English speaking
排除标准
- •Patients unable to cooperate or consent to the study
- •Allergy to local anesthetics
- •Existing infection at planned needle insertion site
- •BMI > 40kg/m2
- •Patients with a history of coagulopathy
- •Emergency amputations
- •Contralateral amputations
- •Patients with a substance use disorder diagnosis
- •Patients on opioids >90 morphine milligram equivalents (MME)/day
研究组 & 干预措施
Single Shot Perineural Popliteal Nerve Block
Single shot perineural popliteal nerve block injection of 10cc 13.3% liposomal bupivacaine combined with 15cc 0.50% bupivacaine hydrochloride within one hour prior to surgery
干预措施: Liposomal bupivacaine (Drug)
Continuous perineural popliteal nerve block catheter
Placement of continuous perineural popliteal nerve block catheter with injection of 30cc 0.5% bupivacaine within one hour prior to surgery, followed by continuous infusion of 10cc 0.3% ropivacaine (current standard practice) for at least 72 hours following surgery. Saphenous single shot 20cc 0.2
干预措施: Bupivacaine Hydrochloride 0.5 % Injectable Solution (Drug)
结局指标
主要结局
Pain Assessed by Numerical Rating Scale (NRS)
时间窗: 72 hours post-operatively
Average NRS pain scores (0-10, 0=no pain, 10=worst possible pain)
次要结局
- Opioid Consumption(72 hours post-operatively)
- Post-operative Length of Stay(Measured from surgical stop time to discharge time, an average of 5 days.)
- Post-operative Pain Assessed by the Short Form McGill Pain Questionnaire-2 (SFMPQ-2)(30 days following surgery)
- Phantom Limb Pain Assessed Using Questions From the Trinity Amputation and Prosthesis Experiences Scales-Revised (TAPES-R)(30 days following surgery)
研究者
Aurora Quaye
Vice Chair of Research, Department of Anesthesiology and Perioperative Medicine, Maine Medical Center
MaineHealth