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临床试验/NCT05556356
NCT05556356终止4 期

Effect of Perioperative Acetaminophen Dosing on Patients Undergoing Surgical Treatment of Basilar Thumb Arthritis

Indiana Hand to Shoulder Center1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2022年9月13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
终止
入组人数
23
试验地点
1
主要终点
Visual Analogue Scale (VAS)

研究概览

简要总结

Basilar thumb arthritis is a common problem that affects 7% of men and 15% of women. It is regarded as one of the more painful procedures commonly performed by hand surgeons. Opioid overuse and diversion are significant problems in the country that contribute to opioid addiction as well as deaths from opioid overdose. Prior studies have examined the effect of different nerve block compositions on perioperative and postoperative analgesia, but none have looked at perioperative loading analgesia. We will attempt to address this problem by exploring alternative analgesia regimens to decrease opioid prescribing after 1st carpometacarpal (CMC) joint arthroplasty.

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
Double (Participant, Care Provider)

盲法说明

Participants unblinded following final data collection.

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

  • Adults (18 years of age or older)
  • Patients presenting with symptomatic 1st CMC arthritis with or without scaphotrapeziotrapezoid arthritis
  • Eaton Classification stage II, III, or IV OA of the first CMC joint based on xrays
  • Patients who plan to undergo a ligament reconstruction and tendon interposition (LRTI) or thumb suspensionplasty procedure within 6 months of enrolling to study
  • Bilateral thumbs included

排除标准

  • <18 years age
  • Prior surgical history of ipsilateral 1st CMC arthroplasty or procedures involving thumb CMC joints
  • Prior ipsilateral tendon rupture or ipsilateral peripheral nerve palsy
  • History of opioid dependency or current chronic opioid use
  • Contraindication to acetaminophen use
  • Contraindication to NSAID use
  • Contraindication or known allergy to peripheral nerve blockade, including coagulopathy
  • Contraindication to supraclavicular block due to anatomic variability or inability to tolerate phrenic nerve blockade.
  • Contraindication to multivitamin use
  • Liver dysfunction

研究组 & 干预措施

Test Group

Experimental

: Preoperative acetaminophen and postoperative standardized pain management regimen

干预措施: Acetaminophen (Drug)

结局指标

主要结局

Visual Analogue Scale (VAS)

时间窗: 2 weeks

Patients report pain on a scale of 0 (no pain) to 100 (worst possible pain)

Number of Narcotic Pills Used

时间窗: 2 weeks

Number of Narcotic Pills Used

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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