Open-Label Placebo Treatment for Acute Postoperative Pain

University Hospital, Basel, Switzerland76 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Postoperative Pain

Interventions

Open-Label PlaceboDRUG

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

treatment as usualOTHER

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital of Basel, Department of Anesthesia

Basel, Switzerland

Outcomes

Primary Outcomes

Difference in morphine consumption

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)

Time frame: 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)

Secondary Outcomes

Difference in morphine request rates

Morphine demand behaviour will be measured by the total number of successful and unsuccessful clicks on the Patient Controlled Analgesia (PCA) pump between T1 and T5 (48 hours)

Time frame: 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

back and leg pain intensity at rest will be measured separately by two 11-point Numeric Rating Scales (NRS, i.e., back / leg pain intensity at rest), which assesses pain intensity by asking participants to rate their pain intensity on a 0 to 10 scale, where 0 is "no pain" and 10 is "worst pain possible"

Time frame: 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 pain intensity while walking

back and leg pain intensity while walking will be measured separately by two 11-point Numeric Rating Scales (i.e., back / leg pain intensity while walking), which assesses pain intensity by asking participants to rate their pain intensity on a 0 to 10 scale, where 0 is "no pain" and 10 is "worst pain possible"

Time frame: 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.

Data from ClinicalTrials.gov

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