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临床试验/NCT04362566
NCT04362566已完成4 期

Randomized Trial of Bupivacaine as Adjuvant for Post-operative Pain in Mohs Micrographic Surgery

University of Missouri-Columbia1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2020年7月30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
174
试验地点
1
主要终点
Pain control

研究概览

简要总结

Mohs micrographic surgery (MMS) is regarded as the gold standard for the treatment of high-risk nonmelanoma skin cancer (NMSC). Pain after MMS peaks on the day of surgery and slowly decreases thereafter. The most common post-operative analgesics include acetaminophen, ibuprofen and narcotics. Lidocaine is the most commonly used anesthetic in MMS, but bupivacaine has been shown in other surgical specialties to be an effective adjuvant to reduce post-operative pain and opioid use when injected locally in the immediate postoperative period. Bupivacaine has also been shown to reduce intra-operative pain during MMS. The investigators plan a single-blinded prospective, randomized, controlled trial to determine if post-operative wound infiltration of bupivacaine versus normal saline improves post-operative pain and decreases need for post-operative pain medications including both narcotic and nonnarcotic analgesics.

详细描述

Mohs micrographic surgery (MMS) is the first-line treatment for high-risk nonmelanoma skin cancer (NMSC) and is increasingly used for melanoma and other cutaneous neoplasms. The surgical technique involves multiple stages of surgery followed by reconstruction and is typically performed under local anesthesia in the office setting in one day.

MMS is generally well tolerated, but post-operative pain is common. Pain peaks on the day of surgery and slowly declines in subsequent days. Risk factors for increased pain may include flap or graft repair type, location on scalp, lip, nose, or ear, younger age, and increased number of lesions treated. Post-operative pain medication is not standardized in dermatological surgery, but often includes non-narcotic analgesics including acetaminophen and ibuprofen, and less commonly narcotic analgesics such as tramadol and oxycodone. Given the current national trend to reduce opioid use, a multimodal approach to pain management has been adopted by many surgical specialties to optimize analgesia perioperatively.

The most commonly used anesthetic in MMS is local subcutaneous infiltration of lidocaine 0.5 - 2% with 1:100,000 - 1:200,000 epinephrine. Lidocaine is quick-acting, can be buffered to reduce injection pain, and is well tolerated, but the duration of action is only two hours, making it less effective for post-operative pain. Bupivacaine with epinephrine has a longer duration of action compared to lidocaine (up to four hours), but it is rarely used alone due to slower onset of action and more painful injection compared with lidocaine. Bupivacaine is used in many other surgical specialties, including general, plastic, and orthopedic surgery, as a peri-operative adjuvant and has been shown to reduce post-operative opioid use. It is generally well tolerated, carrying a class-effect risk of cardiac toxicity in high doses as does lidocaine, but has been shown to be safe in dermatologic surgery when used for wound infiltration. A newer formulation of liposomal bupivacaine has been shown to be even longer lasting and safer, with pain control up to 72 hours and no reported cardiac toxicity. In addition, a recent study has showed subcutaneous infiltration of bupivacaine with epinephrine to be an effective intra-operative pain adjuvant during MMS compared to lidocaine alone.

Pain control post-operatively in MMS may be optimized by including bupivacaine injections at the end of the surgical procedure given its long-lasting anesthetic effects. There are currently no studies addressing the use of bupivacaine as an adjuvant to control post-operative pain during MMS. The investogators propose a prospective randomized controlled trial to evaluate the effectiveness of bupivacaine injection at the conclusion of surgery for reducing post-operative pain and analgesic use.

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 (Participant)

盲法说明

Patients will receive long acting local anesthetic or saline placebo postoperatively, they will be blinded to the arm they are 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

  • a. Adult (18 years or older) patients being treated with Mohs micrographic surgery will be included in this study.
  • b. Surgical procedure must include one of the following:
  • Scalp rotation/transposition/advancement flap
  • Ear rotation/transposition/advancement/interpolation flap or wedge repair
  • Nose rotation/transposition/advancement/interpolation flap, cartilage alar-batten graft (ear donor site)
  • Cheek Mustarde flap
  • Lip rotation/transposition/advancement flap, wedge repair, Abbe flap

排除标准

  • c. Patients must not
  • be pregnant or breastfeeding
  • be taking scheduled narcotic medications
  • use narcotics as a drug of abuse
  • have an allergy to bupivacaine or other amide anesthetics
  • have a contraindication to tramadol
  • have been given narcotic pain medications during the Mohs procedure or subsequent reconstruction
  • have multiple surgical sites treated on the same day

研究组 & 干预措施

Bupivicaine

Active Comparator

Scalp flap: 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc, Ear flap or wedge repair: 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc Nose flap, 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc. Split volume between nose and donor site for melolabial interpolated flap Paramedian forehead flap: 5cc split between forehead donor site and nasal recipient site: 4cc forehead, 1cc nose Cartilage alar-batten graft (ear donor site) 1cc at auricular donor site in addition to bupivacaine used for nasal reconstruction, if any, that qualifies above Cheek Mustarde flap: 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc Lip flap, wedge repair, Abbe flap: 2.5cc bupivacaine for 0-10cm2, additional 1cc for each additional 10cm2 up to max 5cc

干预措施: Bupivacaine (Drug)

Placebo saline

Placebo Comparator

Saline in the same volume as described above for bupivicaine

干预措施: Placebo Saline (Other)

结局指标

主要结局

Pain control

时间窗: 24 hours

Determination if bupivacaine injection postoperatively in clinical scenarios where higher postoperative pain is expected (see protocol) changes the need for narcotic medication (using a binary Yes or No measure) during first 24 hours post-surgery

次要结局

  • 48 hour pain control 1-10 scale(48 hours)
  • 48 hour pain control drug type used if any(48 hours)
  • 48 hour pain control drug amount used if any(48 hours)
  • Adverse effects(48 hours)

研究者

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

Nicholas J Golda

Professor, Dermatology

University of Missouri-Columbia

研究点 (1)

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