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Clinical trial

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

ID
Name
2020-00099;qu19Ruppen
Description
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.
Trial arms
Trial start
2020-05-12
Estimated PCD
2023-01-31
Trial end
2023-01-31
Status
Completed
Treatment
Open-Label Placebo
in addition to Treatment as usual, patients receive placebos without concealment (open-label placebo, OLP)
Arms:
OLP-Group
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)
Arms:
TAU-group
Size
76
Primary endpoint
Difference in morphine consumption
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)
Eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 76, 'type': 'ACTUAL'}}
Updated at
2023-08-22

1 organization

1 product

1 indication

Organization
University Hospital Basel
Product
Open-Label Placebo
Indication
Postoperative Pain