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临床试验/NCT06484439
NCT06484439已完成早期 1 期

"A Prospective Randomized Controlled Trial to Determine Most Effective Post-Operative Analgesia After Third Molar Extraction"

United States Naval Medical Center, San Diego1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年2月14日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Post operative opioid use after third molar extraction

研究概览

简要总结

This is a prospective randomized clinical trial that will investigate which post-operative medications in conjunction with a multimodal analgesia approach can most effectively control post-operative pain and reduce opioid consumption.

详细描述

The recruitment of patients is covered in another section. Once patients are recruited based on inclusion/exclusion criteria, they will be consented and randomized into one of the 2 arms. The pre and perioperative anesthesia protocols will be identical for each arm and will consist of an opioid free general anesthesia. Local anesthesia will be given in an identical fashion in all arms. One cartridge of 2% lidocaine with 1:100k epinephrine will be given as a nerve block for the inferior alveolar nerve bilaterally. Then one cartridge of 0.5% bupivacaine with 1:200k epinephrine will be locally injected for at each of the four 3rd molar sites. Both arms will be injected with 133mg (10cc) of liposomal bupivacaine. The third molars will then be extracted in typical fashion. Each patient will be attached to one of two postoperative arms distinguished by the post-operative medications received. The control arm will be 650 mg Tylenol PO scheduled q6h, 600mg Motrin per os (PO) scheduled q6h and 5 mg hydrocodone PO pro re nata (PRN) q6h. The study arm will be 10 mg Toradol PO q6h, 650 mg acetaminophen PO scheduled q6h, and 5 mg oxycodone PO PRN q6h. The blinded medication will be either the 600mg Motrin or the 10mg Toradol. The patients will be standard 3rd molar extraction post-operative instructions as well as specific instructions on how to take medications. The identity of the patients will be linked to a key that will be kept in a locked box inside a keypad entry office. All future pain assessors will be blinded to the arm of the study in which the patient is attached. The patients will respond to daily pain intensity scores, medications taken, quality of life measures through a survey. The patients will be taught about the surveys during the consent process and again postoperatively. An email or phone will be done for the patients on the following morning for the first 5 days postoperatively. The patient will be instructed to complete the survey that will assess pain, medications taken and quality of life items. The patients will submit these daily until they return to clinic 5 days post-op where they will again submit one survey collectively discussing the outcomes of the previous 5 days. All arms will have the primary investigator's cell phone number if any adverse reactions present themselves.

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
Triple (Participant, Care Provider, Investigator)

盲法说明

Participants will be randomly assigned to one of two groups. Each group will be given one of two post-operative medication regimens consisting of a combination of either (1) Acetaminophen (Tylenol), Oxycodone, and Ibuprofen (Motrin), or (2) Acetaminophen (Tylenol), Oxycodone, and Ketorolac (Toradol).

This research study is a double blind study.

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female 18 years or older
  • Scheduled for 3rd molar extraction (x4) with at least one mandibular 3rd molar impacted
  • American Society of Anesthesiologists classification 1 or 2
  • Able to provide consent, adhere to study schedule, complete study journal, and understand English

排除标准

  • History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics or opioids
  • Contraindication to lidocaine, epinephrine, bupivacaine, or hydrocodone
  • Significant drug allergy history
  • Currently pregnant or nursing at time of study or within 1 month of drug administration
  • Severe renal or hepatic impairment, significant cardiovascular disease; migraines, frequent headaches.
  • Use of any of the following medication within 1 month of EXPAREL infiltration or if the medications are being given to control pain: Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Nonadrenaline Reuptake Inhibitors (SNRIs), gabapentin, pregabalin, or duloxetine.
  • Current use of systemic glucocorticosteroids within 1 month of enrollment in the study
  • No concurrent surgical procedures within 2 weeks before or after 3rd molar extractions

研究组 & 干预措施

Acetaminophen, Ibuprofen, Hydrocodone Control arm

Active Comparator

The control arm will be 650 mg Acetaminophen PO scheduled q6h, 600mg Ibuprofen PO scheduled q6h and 5 mg Hydrocodone PO PRN q6h.

干预措施: Acetaminophen (Drug)

Acetaminophen, Ibuprofen, Hydrocodone Control arm

Active Comparator

The control arm will be 650 mg Acetaminophen PO scheduled q6h, 600mg Ibuprofen PO scheduled q6h and 5 mg Hydrocodone PO PRN q6h.

干预措施: Ibuprofen (Drug)

Acetaminophen, Ibuprofen, Hydrocodone Control arm

Active Comparator

The control arm will be 650 mg Acetaminophen PO scheduled q6h, 600mg Ibuprofen PO scheduled q6h and 5 mg Hydrocodone PO PRN q6h.

干预措施: Hydrocodone (Drug)

Ketorolac, Acetaminophen, Oxycodone Study arm

Experimental

The study arm will be 10 mg Ketorolac PO q6h, 650 mg Acetaminophen PO scheduled q6h, and 5 mg Oxycodone PO PRN q6h.

干预措施: Ketorolac (Drug)

Ketorolac, Acetaminophen, Oxycodone Study arm

Experimental

The study arm will be 10 mg Ketorolac PO q6h, 650 mg Acetaminophen PO scheduled q6h, and 5 mg Oxycodone PO PRN q6h.

干预措施: Oxycodone (Drug)

Ketorolac, Acetaminophen, Oxycodone Study arm

Experimental

The study arm will be 10 mg Ketorolac PO q6h, 650 mg Acetaminophen PO scheduled q6h, and 5 mg Oxycodone PO PRN q6h.

干预措施: Acetaminophen (Drug)

结局指标

主要结局

Post operative opioid use after third molar extraction

时间窗: Up to five days post operative procedure.

Daily survey will be used to assess the amount of post operative opioid us including dosage and frequency of use.

Post operative pain control after third molar extraction

时间窗: Up to five days post operative procedure.

All participants will complete a daily survey on the medications taken to relieve pain.

Post operative pain assessment after third molar extraction

时间窗: Up to five days post operative procedure.

Participants fill out daily for five days post operative procedure the Numeric Pain Rating Scale (NPRS). This is a ten point scale with 0 = No pain, 5 = Moderate pain, 10 = Worst possible pain. The higher the number is a worse outcome.

Post operative quality of life assessment after third molar extraction

时间窗: Up to five days after third molar extraction.

Post operative quality of life was ascertained with the 10 point Likert scaled question, "What is your rating for your actual overall comfort?'. 1 = Very low overall comfort, 5 = Neither low or high overall comfort, 10 = Very high overall comfort. The higher the score means a better outcome. This question is part of the daily survey that participants filled out for five days post operative procedure.

次要结局

未报告次要终点

研究者

发起方
United States Naval Medical Center, San Diego
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Patrick Morrell

Principal Investigator

United States Naval Medical Center, San Diego

研究点 (1)

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