Clinical trial NCT04339023: Open-Label Placebo Treatment for Acute Postoperative Pain
Official title: Open-Label Placebo Treatment for Acute Postoperative Pain: A Randomized Controlled Trial (OLP-POP Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: postoperative pain
Open-Label Placebo
morphine
Transforaminal Lumbar Interbody Fusion
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Difference in morphine consumption
timeFrame: 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:
measure: Difference in morphine request rates
timeFrame: 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)
measure: Difference in pain intensity at rest
timeFrame: 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)
measure: Difference in pain intensity while walking
timeFrame: 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.
measure: Difference in comprehensive pain assessment and patients' perception of postoperative pain management
timeFrame: The scale will be administered on the day before surgery (T-1), in the morning of the first day post-surgery (i.e., between 07:00 and 09:00; T0) , after the pain nurse visit 09:00 am day 2 (T3) and 09:00 am day 3 (T5) post-surgery
measure: Difference in requested rescue analgesics
timeFrame: After trial completion of participants, study team members will extract the data from hospital records for the time periods of: the day of surgery (T0) till first day post-surgery at 09:00 am (T1) and T1 to T5 (09:00 am day 3 post-surgery)
measure: Opioid-Related Side Effects
timeFrame: After trial completion of participants, study team members will extract the data from hospital records for the time periods of: the day of surgery (T0) till first day post-surgery at 09:00 am (T1) and T1 to T5 (09:00 am day 3 post-surgery)
measure: Length of Post-Surgery Hospitalisation
timeFrame: Length of Post-Surgery Hospitalisation, approximately 14 days after surgery
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital of Basel, Department of Anesthesia
Study officials:
affiliation: University Hospital of Basel, Department of Anesthesia
name: Wilhelm Ruppen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Basel,Faculty of Psychology
name: Jens Gaab, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sezer D, de Leeuw M, Netzer C, Dieterle M, Meyer A, Buergler S, Locher C, Ruppen W, Gaab J, Schneider T. Open-Label Placebo Treatment for Acute Postoperative Pain (OLP-POP Study): Study Protocol of a Randomized Controlled Trial. Front Med (Lausanne). 2021 Nov 5;8:687398. doi: 10.3389/fmed.2021.687398. eCollection 2021.