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临床试验/NCT06450028
NCT06450028已完成4 期

Lidocaine Versus Bupivacaine in Orthognathic Surgery: A Randomized Controlled Trial

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年10月1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
入组人数
64
试验地点
1
主要终点
Patient-Reported Numbness

研究概览

简要总结

In this research study, we want to learn more about the impact of two different local anesthetics (bupivacaine and lidocaine) on patient experience following orthognathic (jaw) surgery. Both anesthetics are within the standard of care for dental and orthognathic procedures, but can vary in how quickly they take action and how long they last. This study will provide us with a greater understanding of how anesthetic choice affect patient outcomes, and how we can strive to make these outcomes as favorable as possible.

详细描述

Aim 1: To determine if differences exist in patient-reported outcomes regarding the use of bupivacaine and lidocaine in orthognathic surgery.

Aim 2: To assess patient experiences with pain, numbness, light touch perception, temperature sensation and narcotic and pain medication consumption following administration of bupivacaine and lidocaine in orthognathic surgery.

Lidocaine (known as lignospan commercially) and bupivacaine (known as marcaine or sensorcaine commercially) are two local anesthetics used ubiquitously for procedures in the oral cavity. Lidocaine is known for its fast-acting properties, which can take effect within one to two minutes of administration. However, lidocaine also has a relatively short duration of action, typically lasting about one to two hours. On the other hand, bupivacaine is slightly slower acting (tales effect in 10-15 minutes) but has a much longer duration of action (up to eight hours). Both local anesthetics are used in orthognathic surgery (jaw surgery) and are within the standard of care for these procedures. Lidocaine and bupivacaine are both administered with epinephrine as an additive to reduce bleeding in the operative field and improve the depth and duration of anesthesia. Some patients may experience significant pain postoperatively if their local anesthetic is metabolized too quickly, while others may experience prolonged numbness and decreased sensation if their local anesthetic has too long of a duration of action.

Patients will be randomized into two equally sized groups. Group 1 will receive 0.25% bupivacaine hydrochloride and epinephrine 1:200,000 on the left side of their mandible and/or maxilla and 2% lidocaine hydrochloride with 1:100,000 epinephrine on the right side of their mandible and/or maxilla. Group 2 will receive 0.25% bupivacaine hydrochloride and epinephrine 1:200,000 on the right side of their mandible and/or maxilla and 2% lidocaine hydrochloride with 1:100,000 epinephrine on the left side of their mandible and/or maxilla. The use of bupivacaine and lidocaine are common practice in orthognathic surgery and are frequently used in conjunction with each other. Email reminders will be sent to the oral surgeon reminding them that their patients is enrolled in this study. Following that email, another email will be sent to the oral surgeon by another individual to inform them of which side they are able to administer which anesthetic. This allows the research staff member performing postoperative assessments to remain blinded.

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
Double (Participant, Outcomes Assessor)

盲法说明

The participant will not know which anesthetic they received on each side of their jaw. The care provider, who will be administering the anesthetic intraoperatively, will know which anesthetic is being administered on each side of the participant's jaw. The outcomes assessor will not know which anesthetics was administered on each side of the participant's jaw.

入排标准

年龄范围
15 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Undergoing an orthognathic procedure at Boston Children's Hospital
  • •Between the ages of 15 and 35 years old

排除标准

  • •Any patient undergoing any other procedures in addition to their orthognathic procedure during the same sedation period (extraction, bone graft, etc.).
  • •Any patient with a history of chronic pain.
  • •Any patient with a history of an allergic reaction to bupivacaine or lidocaine.
  • •Any patient with known neurologic changes to the lip or chin.
  • •Any patient not enrolled in an Enhanced Recovery After Surgery (ERAS) Protocol.
  • •Any patient known to be pregnant or with a positive pregnancy test prior to the procedure.

研究组 & 干预措施

Bupivacaine Right, Lidocaine Left

Active Comparator

Group 2 will receive 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine on the right side of their jaw and 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine on the left side of their jaw. This dosage will be administered once as peripheral nerve blocks at the beginning of the participant's orthognathic procedure.

干预措施: 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine (Drug)

Bupivacaine Left, Lidocaine Right

Active Comparator

Group 1 will receive 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine on the left side of their jaw and 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine on the right side of their jaw. This dosage will be administered once as peripheral nerve blocks at the beginning of the participant's orthognathic procedure.

干预措施: 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine (Drug)

Bupivacaine Left, Lidocaine Right

Active Comparator

Group 1 will receive 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine on the left side of their jaw and 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine on the right side of their jaw. This dosage will be administered once as peripheral nerve blocks at the beginning of the participant's orthognathic procedure.

干预措施: 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine (Drug)

Bupivacaine Right, Lidocaine Left

Active Comparator

Group 2 will receive 10 cc of 0.25% bupivacaine hydrochloride with 1:200,000 epinephrine on the right side of their jaw and 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine on the left side of their jaw. This dosage will be administered once as peripheral nerve blocks at the beginning of the participant's orthognathic procedure.

干预措施: 6.8 cc of 2% lidocaine hydrochloride with 1:100,000 epinephrine (Drug)

结局指标

主要结局

Patient-Reported Numbness

时间窗: Outcome measures were assessed (1) approximately 2 hours after each subject's orthognathic procedure, (2) approximately four hours after each subject's orthognathic procedure, and (3) approximately one week after each subject's orthognathic procedures.

Pain will be measured by prompting participants to rank their pain on a scale (minimum 1, maximum 10; 1 meaning minimal pain and 10 meaning maximum pain) on each side of their mandible/maxilla.

次要结局

  • Light Touch Perception(Outcome measures were assessed (1) approximately 2 hours after each subject's orthognathic procedure, (2) approximately four hours after each subject's orthognathic procedure, and (3) approximately one week after each subject's orthognathic procedures.)
  • Directionality Perception(Outcome measures were assessed (1) approximately 2 hours after each subject's orthognathic procedure, (2) approximately four hours after each subject's orthognathic procedure, and (3) approximately one week after each subject's orthognathic procedures.)
  • Temperature Perception(Outcome measures were assessed (1) approximately 2 hours after each subject's orthognathic procedure, (2) approximately four hours after each subject's orthognathic procedure, and (3) approximately one week after each subject's orthognathic procedures.)
  • Number of Participants With Patient-Reported Numbness(Outcome measures were assessed (1) approximately 2 hours after each subject's orthognathic procedure, (2) approximately four hours after each subject's orthognathic procedure, and (3) approximately one week after each subject's orthognathic procedures.)
  • Number of Participants With Overall Side Preference(Outcome measures were assessed (1) approximately 2 hours after each subject's orthognathic procedure, (2) approximately four hours after each subject's orthognathic procedure, and (3) approximately one week after each subject's orthognathic procedures.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark Green

Oral and Maxillofacial Surgeon

Boston Children's Hospital

研究点 (1)

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