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临床试验/NCT05635916
NCT05635916已完成4 期

A Prospective, Randomized Trial of Liposomal Bupivacaine Compared to Conventional Bupivacaine on Pain Control and Post-Operative Opioid Use in Receiving Adductor Canal Blocks for Total Knee Arthroplasty

Northern Light Mercy Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年9月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
To compare postoperative pain scores and opioid consumption at 48 hours after surgery.

研究概览

简要总结

Total knee arthroplasty (TKA), also known as a knee replacement, is a procedure performed to reduce severe pain and improve function of the joint. Managing postoperative pain can be challenging following TKA, and inadequate relief can lead to impaired mobility and persistent opioid use. Adductor canal nerve blocks (ACB), have shown significant benefit in improving postoperative analgesia and patient satisfaction. However, the local anesthetic used currently for these blocks only provides temporary relief that wears off within 24 hours. Liposomal bupivacaine is an extended-release local anesthetic agent that can provide up to 72 hours of pain relief, however it is unclear if its use is also effective in ACBs for knee surgery. The purpose of this study is to determine if liposomal bupivacaine is better than conventional bupivacaine in improving pain control, opioid consumption, and length of stay in patients scheduled for TKA.

详细描述

BACKGROUND The femoral nerve block and the adductor canal nerve block are two regional anesthesia techniques used to manage pain control following TKA Femoral nerve blocks were the first peripheral nerve block employed for post-surgical analgesia, however they are now less frequently used due to significant drawbacks that influence recovery. The femoral nerve provides motor and sensory innervation to the quadriceps muscle. Blockade of the motor branches of this nerve leads to quadriceps weakness and increased risk of falling after surgery. Additionally, for similar reasons, ambulation after surgery can be significantly delayed. In contrast, the adductor canal block does not affect the quadriceps muscle, as it avoids the motor branches of the femoral nerve. The location of the block, located in the mid-thigh, mainly affects the sensory neuronal branches of the saphenous nerve. It has been found as a superior method for post-surgical analgesia since motor weakness is spared.

The adductor canal block is an interfascial plane block that can be performed as a single injection, or as a continuous infusion via insertion of a catheter. Continuous peripheral nerve blocks can provide prolonged post-operative analgesia, however, they are associated with several complications including catheter infection, obstructions, and fluid leakage Catheter placement takes a significant amount of time to perform and can consume valuable clinical resources. Additionally, catheter displacement can be frequent with ACBs, since the aponeurosis where the saphenous nerve lies is superficial, leading to easy dislodgement and block failure. In comparison, a single injection of local anesthetic in the adductor canal space is much simpler to place, is more cost effective, and has a lower infection risk. However, risk of rebound pain is much higher in single injection nerve blocks due to their shorter duration of action.

Liposomal bupivacaine (LB) is an extended-release local anesthetic that combines the benefits of a single injection nerve block with the long-lasting effects of continuous catheter infusions. LB received Food and Drug Administration approval in October 2011 for post-surgical anesthesia via local infiltration and, in April 2018, for interscalene brachial plexus blocks. LB has been reported to provide analgesia for up to 72 hours, making it the longest lasting local anesthetic currently available.

There have been several studies evaluating the effectiveness of perineural LB in improving peripheral nerve block analgesia compared to non-liposomal anesthetics for total knee arthroplasty but the evidence is not definitive. A meta-analysis performed found that LB was associated with higher pain relief compared to traditional bupivacaine and reduced opioid related complications in TKA patients. Another study found decreased opioid consumption and improved pain scores within the early post-operative period following TKA, but there was no significant difference in length of hospital stay, patient satisfaction, or adverse postoperative events. Another study found patients receiving LB for TKA had no improvement in narcotic use, length of stay, patient reported pain, or functional ability compared to those who received a single shot short acting ropivacaine nerve block. A recent meta-analysis concluded that perineural infiltration of LB in various, distinct peripheral nerve block locations was not superior to non-liposomal bupivacaine.

There is an institutional desire to improve postoperative pain outcomes and shorten length of stay in patients undergoing TKA. It is possible that liposomal bupivacaine may help improve these measures, however, current evidence is inconclusive. The purpose of this study is to investigate the analgesic efficacy of liposomal bupivacaine comparative to conventional bupivacaine in ACBs for individuals undergoing TKA.

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
Single (Outcomes Assessor)

盲法说明

The randomization scheme will be developed using NQuery Software (Statistical Solutions, Boston, MA). The analyst will provide the research coordinator with randomization assignments in sequentially-numbered opaque envelopes. As the study is unblinded, both patients and providers will be aware of the randomization assignment. To help mitigate bias, the team members collecting and entering data will be masked regarding the patient's assignment. The REDCap database has the randomization assignments in an instrument separate from the study data collection instruments, allowing for data entry without seeing which group the subject is in.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 18 years and older who are scheduled for a total knee arthroplasty at Northern Light Mercy Hospital

排除标准

  • Patients under the age of 18

研究组 & 干预措施

Liposomal Bupivacaine

Experimental

Adductor canal block using liposomal bupivacaine and conventional bupivacaine

干预措施: Liposomal bupivacaine (Drug)

Standard of Care

Active Comparator

Adductor canal block using conventional bupivacaine

干预措施: Bupivacaine (Drug)

结局指标

主要结局

To compare postoperative pain scores and opioid consumption at 48 hours after surgery.

时间窗: Measured at 48 hours post-op

The primary outcome of this study will be composite pain scores 24 hours after surgery. Others have shown that composite pain scores quantify pain with greater accuracy than a single measurement. Jensen et. al. concluded in their study that composite pain intensity scores from two or more individual ratings of pain are valid for detecting treatment effects.23 Pain scores will be measured using a numeric rating scale (NRS) (0=no pain; 10= worst possible pain) "Worst," "average," and "least" pain scores will be assessed for the preceding time interval at 24, 48, and 72 hours following surgery. If a participant is discharged prior to 72 hours after surgery, they will be given a log to record their pain scores and pain medication use to report to study staff via telephone.

To compare postoperative pain scores and opioid consumption at 72 hours after surgery.

时间窗: Measure at 72 hours post-op

The primary outcome of this study will be composite pain scores 24 hours after surgery. Others have shown that composite pain scores quantify pain with greater accuracy than a single measurement. Jensen et. al. concluded in their study that composite pain intensity scores from two or more individual ratings of pain are valid for detecting treatment effects.23 Pain scores will be measured using a numeric rating scale (NRS) (0=no pain; 10= worst possible pain) "Worst," "average," and "least" pain scores will be assessed for the preceding time interval at 24, 48, and 72 hours following surgery. If a participant is discharged prior to 72 hours after surgery, they will be given a log to record their pain scores and pain medication use to report to study staff via telephone.

To compare the efficacy of liposomal bupivacaine to conventional bupivacaine for adductor canal blocks in adults scheduled for total knee arthroplasty.

时间窗: Measured at 24 hours post-op

The primary outcome of this study will be composite pain scores 24 hours after surgery. Others have shown that composite pain scores quantify pain with greater accuracy than a single measurement. Jensen et. al. concluded in their study that composite pain intensity scores from two or more individual ratings of pain are valid for detecting treatment effects.23 Pain scores will be measured using a numeric rating scale (NRS) (0=no pain; 10= worst possible pain) "Worst," "average," and "least" pain scores will be assessed for the preceding time interval at 24, 48, and 72 hours following surgery. If a participant is discharged prior to 72 hours after surgery, they will be given a log to record their pain scores and pain medication use to report to study staff via telephone.

次要结局

  • To compare total length of postoperative stay following surgical stop time.(Measure at discharge, an average of 1 day.)
  • To compare postoperative opioid consumption measured as morphine milligram equivalents (MME) at 24 hours postoperatively.(Measured intraoperatively, in PACU at 4 hours post-op, and at 24,48, and 72 hours post-op.)

研究者

发起方
Northern Light Mercy Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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