A Randomized Controlled Trial Evaluating the Efficacy of Conditioned Open Label Placebo (COLP) to Limit Opioid Reliance for Postoperative Pain Management
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 222
- 试验地点
- 2
- 主要终点
- Opioids consumption
研究概览
简要总结
The primary objective is to evaluate the efficacy of two Conditioned Open Label Placebos (COLP): COLP pill and COLP odor to reduce opioid intake for postoperative (thoracic and spinal surgery) pain management compared to the opioid only usual treatment (TAU).
详细描述
Patients, eligible for an elective thoracic or spinal surgery, will be randomized into either standard of care, COLP_pill or COLP_odor. Patients in COLP groups will be asked to pair each opioid intake with an open label placebo intake (either a pill or an inhalation) for postoperative (POD) day 0 to 17. From POD 2, patients in the intervention arms will be additionally asked to take OLP alone 3 times a day. Patients will have unrestricted access to pain killers. Patients will daily assess opioid intake, pain intensity, side effects, mobility and sense of agency using a e-dairy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spinal or thoracic elective surgery for the indications mentioned above
- •Able to give informed consent
- •Interested in trying COLP as complementary pain management therapy
- •Able to fill a e-diary at home
排除标准
- •Cognitive impairment (MOCA score <26)
- •Inability to engage in the intervention of the study e.g. inability to communicate in French without a translator, severe hearing impairment without any hearing aid available at the time of intervention, anosmia or intolerance to eugenol.
- •Acute psychiatric (e.g. psychotic or suicidal ideation) or somatic (e.g. unstable cardio-respiratory condition) co-morbidity preventing full engagement during intervention
- •Opioid use disorder (toxicomania) or contraindication to pain management using opioids (allergy, refusal, ...)
- •Intolerance to placebo ingredients
研究组 & 干预措施
Efficacy of conditioned open label placebo pill
On postoperative day 0, participant will self-administer one OLP with all opioid analgesics (whether administered intravenously or orally). This pairing will be done from postoperative day 0 to postoperative day 17.
Starting on postoperative day 2, participants take 3 scheduled placebo doses (pills or inhalation) every day, at 3 convenient times. In parallel, the OLP pairing to standard and rescue doses of opioids will continue.
The patients are told to continue taking both scheduled standalone COLP and paired COLP (if needed) until postoperative day 17.
干预措施: Placebo (Behavioral)
Efficacy of conditioned open label placebo odor
1 drops of clove oil (i.e. eugenol) will be disposed on a cotton and inserted into a stick. The patients will be asked to actively smell them by sniffing using a stick of inhalation. On postoperative day 0, participant will self-administer one OLP with all opioid analgesics (whether administered intravenously or orally). This pairing will be done from postoperative day 0 to postoperative day 17.
On postoperative day 2, participants take 3 scheduled placebo doses (pills or inhalation) every day, at 3 convenient times. In parallel, the OLP pairing to standard and rescue doses of opioids will continue.
The patients are told to continue taking both scheduled standalone COLP and paired COLP (if needed) until postoperative day 17
干预措施: Placebo (Behavioral)
Standard of care
Usual postoperative pain management, relying mainly on opioids
干预措施: Placebo (Behavioral)
结局指标
主要结局
Opioids consumption
时间窗: 17 days
Cumulative opioids intake as postoperative consumption (in MgMeq)
次要结局
- Time to Opioid withdrawal (in days)(until the 6 months follow-up)
- Postoperative pain intensity(17 days)
- Satisfaction with postoperative management(17 days)
- Mobility(17 days)
- Sense of agency(17 days)
- Side effects intensity(17 days)
研究者
Chantal Berna Renella
Professor
Centre de Médecine Intégrative et Complémentaire (CEMIC)