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临床试验/NCT04574778
NCT04574778招募中3 期

Randomized Trial of IV Versus Oral Acetaminophen for Ambulatory Lumbar Discectomy or Single-level Decompression

Rothman Institute Orthopaedics1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2021年3月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
入组人数
82
试验地点
1
主要终点
Postoperative opioid usage

研究概览

简要总结

Effective non-opioid analgesics are of particular interest in ambulatory surgery, as providers may be able to reduce pain while avoiding perioperative opioids that can delay same day discharge. The value of maintaining an efficient flow of patients from the perioperative area to discharge is an important metric for same day surgery centers, and an improvement in efficiency with IV acetaminophen could potentially offset the increased cost of the medication while providing a more pleasant surgical experience for patients. The goal of this study is to compare the efficacy of intraoperative IV administration vs. preoperative oral administration of acetaminophen on postoperative opioid utilization, patient-reported pain scores, opioid-related adverse effects, and time to recovery and discharge from the post-anesthesia care unit (PACU) after ambulatory lumbar discectomy.

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, Outcomes Assessor)

盲法说明

Only those performing postoperative assessments and the participants will be blinded.

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

  • Age greater than 18 years-old
  • Weight greater than 50 kg body weight
  • ASA physical status I-III
  • English-speaking

排除标准

  • Weight less than 50 kg
  • Pregnancy or breast feeding
  • revision surgery
  • Contraindications to the administration of acetaminophen (e.g. allergy, liver failure, etc)
  • Chronic pain conditions unrelated to back pain
  • Opioid tolerance ( defined as taking greater than oxycodone 20 mg daily for a week during the past month).

研究组 & 干预措施

Group 1: IV acetaminophen and PO placebo

Active Comparator

Group 1 will receive 1000 mg of IV acetaminophen approximately 30 minutes prior to skin closure and will receive oral placebo in the holding area prior to surgery

干预措施: Acetaminophen (Drug)

Group 2: PO acetaminophen

Active Comparator

Group 2 will receive 1000 mg of PO acetaminophen in the holding area and will not receive an IV placebo.

干预措施: Acetaminophen (Drug)

结局指标

主要结局

Postoperative opioid usage

时间窗: 1 day

Postoperative opioid usage over the first 24 hours will be reported in IV morphine equivalents

次要结局

  • Number of patients who report nausea or vomiting(1 day)
  • Mean pain score(1 day)
  • Quality of recovery(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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