Open-Label Placebo Treatment for Acute Postoperative Pain: A Randomized Controlled Trial (OLP-POP Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Difference in morphine consumption
研究概览
简要总结
This study is to evaluate whether the amount of morphine intake in acute postoperative pain following minimally invasive Transforaminal Lumbar Interbody Fusion (TLIF) can be decreased with an Open-Label Placebo (OLP) intervention (comprising the administration of sodium chloride (NaCl) injections and an evidence-based treatment rationale) in comparison to a "Treatment As Usual" (TAU) control group.
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
- 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
- 否
入选标准
- •Signed Informed Consent
- •Scheduled to receive a TLIF procedure at University Hospital Basel (USB)
- •18 years or older
- •German speaking
- •Able to understand the study and its outcome measures
排除标准
- •Known chronic pain, which is unrelated to problem targeted by the surgery
- •Known neuromuscular disease
- •Known mental disorders
- •Known drug or massive alcohol intake or of other psychoactive substances
- •Known kidney or liver disease (glomerular filtration rate (GFR)/ GFR < 30)
- •Contraindications to the class of drugs under investigation, e.g., known hypersensitivity or allergy to the investigational product
- •Parallel participation in another study with investigational drugs
- •More than 30 mg/day (equivalent dose of oral morphine) preoperative opioid consumption
研究组 & 干预措施
OLP-Group
patients will receive in addition to TAU, 2 open-label Placebo (OLP) injections (containing each 5 ml of NaCl 9%) per day for two consecutive days following minimally invasive TLIF
干预措施: Open-Label Placebo (Drug)
TAU-group
The treatment as usual (TAU) group will serve as control group and will control for the natural course of postoperative pain under usual medication intake, following minimally invasive TLIF
干预措施: treatment as usual (Other)
结局指标
主要结局
Difference in morphine consumption
时间窗: starting on the first day post-surgery at 09:00 am (T1) and ending on the third day of surgery at 09:00 am (T5). morphine records will be read out twice a day (9:00 am and 16:45)
cumulative dose (i.e., total amount) of self-administered morphine within 48 hours starting on the first day post-surgery at 09:00 am (T1) and ending on the third day of surgery at 09:00 am (T5)
次要结局
- Difference in requested rescue analgesics(After trial completion of participants, study team members will extract the data from hospital records for the time periods of: the day of surgery (T0) till first day post-surgery at 09:00 am (T1) and T1 to T5 (09:00 am day 3 post-surgery))
- Difference in morphine request rates(between T1 (9:00 am day post surgery) and T5 (9:00 am, 3rd day post surgery) (48 hours, morphine records will be read out twice a day (9:00 am and 16:45))
- Difference in pain intensity at rest(The two "at rest" scales (for leg and back pain) will be administered every two hours starting after transport to normal ward on the day of surgery (T0) until 09:00 am on the third day post-surgery (T5) and as well before surgery (T-1))
- Difference in comprehensive pain assessment and patients' perception of postoperative pain management(The scale will be administered on the day before surgery (T-1), in the morning of the first day post-surgery (i.e., between 07:00 and 09:00; T0) , after the pain nurse visit 09:00 am day 2 (T3) and 09:00 am day 3 (T5) post-surgery)
- Opioid-Related Side Effects(After trial completion of participants, study team members will extract the data from hospital records for the time periods of: the day of surgery (T0) till first day post-surgery at 09:00 am (T1) and T1 to T5 (09:00 am day 3 post-surgery))
- Length of Post-Surgery Hospitalisation(Length of Post-Surgery Hospitalisation, approximately 14 days after surgery)
- Difference in pain intensity while walking(The two "while walking" scales will be administered the day before surgery (T-1), after transport to normal ward (i.e., at T0), at T2 (16:45, 1st day after surgery), T4 (16:45 2nd day post surgery), respectively.)