跳至主要内容
临床试验/NCT05202080
NCT05202080进行中(未招募)不适用

Effect of a Pre-operative Internet-based Educational Video, Providing Both Opioid Counselling and Pain Coping Skills, on Post-operative Opioid Consumption

Sunnybrook Health Sciences Centre1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2022年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
220
试验地点
1
主要终点
Post operative opioid consumption

研究概览

简要总结

One of the most challenging issues in modern medicine is the current opioid epidemic. Given the association between opioid use after surgery and the development of opioid addiction, an essential goal of the medical community should be to develop strategies aimed at instructing the safe use of opioids. In addition, instructions on how to use non-opioid painkillers and exercises and techniques to better cope with pain can be used to reduce the patients opioid requirements after surgery. This study aims to evaluate the effect of providing an online educational video presentation to patients prior to surgery. This will be a 30 minute video which will provide the study participants with instructions on how best to use their opioid and non-opioid medication for pain and also teach the study participants exercises and techniques to better cope with their pain. This intervention will be used with a view to reduce the amount of opioids used by patients following hip or knee replacement surgery. Participants will be followed during their immediate phase after surgery to determine how much pain killers the participants have used and at six weeks the participants will be asked to return their unused opioids to see how much the participants have used in total.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

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

  • Patients must be adults (> 18 years of age) undergoing knee or hip arthroplasty.
  • Patients will be ASA 1-3 undergoing elective surgery.
  • English speaking patients with internet and computer access at home will be included.
  • Patients with pre-existing psychological conditions who receive either pharmaceutical or talk-based therapy will be included.
  • Patients must meet a minimum cognitive capacity to understand the instructions for the Opioid Counseling and Pain Coping Skills presentation. This will be assessed by the administration of the Montreal Cognitive Assessment during screening (MoCA), whereby a minimum score of 18 will be required to meet inclusion into the study.

排除标准

  • Significant cognitive impairment.
  • Chronic pain, long-term opioid therapy
  • Renal replacement therapy
  • Standing opioid requirements
  • Neuropathic pain
  • Fractures requiring emergency surgery
  • End stage cardiac or respiratory disease
  • Severe hepatic dysfunction,
  • Patients with severe psychiatric disorders
  • Vision loss
  • Allergy to local anesthesia.
  • Patients who refuse to consent to neuraxial anesthesia and/or peripheral nerve blocks will also be excluded.

研究组 & 干预措施

Opioid Counseling and PCS Video Group

Experimental

This arm of the study will receive the opioid counseling and pain coping skills video 2 weeks prior to their surgery in addition to the conventional information provided to all patients undergoing total joint arthroplasty.

干预措施: Opioid Counseling and Pain Coping Skills Video (Other)

Standard of Care Group

No Intervention

This arm of the study will the conventional information provided to all patients undergoing total joint arthroplasty.

结局指标

主要结局

Post operative opioid consumption

时间窗: From surgery until 72 hours postoperatively.

Total opioid consumption during the first 72 hours following THA or TKA surgery, measured in oral morphine equivalents.

次要结局

  • Postoperative Pain(On postoperative days 1/2/3, and 1- and 6-week follow-up.)
  • Length of hospital stay(From day of admission until 72 hours postoperatively.)
  • Time to first opioid demand dose(In the first 24 hours after surgery.)
  • Post-operative complication rate(24 hours after surgery, and 1/6 week follow-ups.)
  • Total opioid consumption at 6-week follow-up(6 weeks after surgery.)
  • Need for rescue opioid breakthrough therapy(From surgery until 24 hours postoperatively.)
  • Participant Compliance(Day of surgery)
  • Participant satisfaction at baseline(Baseline (up to 1 week before surgery).)
  • Participant satisfaction at 1 week(1 week after surgery.)
  • Participant satisfaction at 6 weeks(6 weeks after surgery.)

研究者

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

Dr. Ahtsham Niazi

Associate Professor

Sunnybrook Health Sciences Centre

研究点 (1)

Loading locations...

相似试验