Open-Label Placebo Treatment for Acute Postoperative Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-12

Study Completion Date

2023-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Open-Label Placebo

Intervention Type DRUG

in addition to Treatment as usual, patients receive placebos without concealment (open-label placebo, OLP)

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

Group Type OTHER

treatment as usual

Intervention Type OTHER

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)

Interventions

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Open-Label Placebo

in addition to Treatment as usual, patients receive placebos without concealment (open-label placebo, OLP)

Intervention Type DRUG

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)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No