NCT04339023

Open-Label Placebo Treatment for Acute Postoperative Pain

Open-Label Placebo Treatment for Acute Postoperative Pain: A Randomized Controlled Trial (OLP-POP Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Open-Label Placebo	in addition to Treatment as usual, patients receive placebos without concealment (open-label placebo, OLP)
OTHER	treatment as usual	usual medication intake following minimally invasive TLIF. TAU consists of 3 gram Paracetamol per os a day, a patient-controlled morphine pump (Maximum of 2 milligram (mg) every 12 minutes) and rescue medication (1000 mg of Metamizol, maximum every 6 hours)

Timeline

• Start date: 2020-05-12
• Primary completion: 2023-01-31
• Completion: 2023-01-31
• First posted: 2020-04-08
• Last updated: 2023-08-22

Locations

1 site across 1 country: Switzerland