Open-Label Placebo Treatment for Acute Postoperative Pain (OLP-POP)

University Hospital Basel

Status: Completed

Conditions: Postoperative Pain

Treatments: Other: treatment as usual; Drug: Open-Label Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04339023

2020-00099 qu19Ruppen;

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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76 participants in 2 patient groups

OLP-Group

Experimental group

Description:

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

Treatment:

Drug: Open-Label Placebo

TAU-group

Other group

Description:

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

Treatment:

Other: treatment as usual