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Postoperative PainOLP-POPNCT04339023

Open-Label Placebo Treatment for Acute Postoperative Pain

A study testing treatment as usual in people with Postoperative Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Postoperative Pain
What is being tested?
treatment as usual
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
76 participants
Where
1 siteSwitzerland
Study dates
12 May 2020to 31 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Hospital of Basel, Department of Anesthesia

    Basel, 4031

Other trials in Switzerland

About this study

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

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.

Being tested
Open-Label Placebo, treatment as usual
Keywords
postoperative pain, Open-Label Placebo, morphine, Transforaminal Lumbar Interbody Fusion
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

Study groups in NCT04339023
Study groupRoleWhat they receive
OLP-GroupExperimentalpatients 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
Receives: Drug: Open-Label Placebo
TAU-groupOtherThe 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
Receives: Other: treatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 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 (7)

  1. 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)

    Measured: 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)

  2. 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"

    Measured: 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)

  3. 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"

    Measured: 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.

  4. Difference in comprehensive pain assessment and patients' perception of postoperative pain management

    will be assessed by the German version of the International Pain Outcomes (IPO) Questionnaire. The IPO assesses patients pain experience and outcomes regarding patient reported aspects

    Measured: 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

  5. Difference in requested rescue analgesics

    will be regularly assessed as part of standard procedures of the hospital and will be documented in the electronic hospital record of each patient

    Measured: 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)

  6. Opioid-Related Side Effects

    nausea, vomiting and constipation (i.e., stool frequency, vomiting and amount of delivered laxatives and antiemetics) are regularly assessed and documented as part of standard hospital procedures

    Measured: 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)

  7. Length of Post-Surgery Hospitalisation

    Length of Post-Surgery Hospitalisation, upon participants trial completion this data will be extracted by study team members from the electronic hospital record of each patient

    Measured: Length of Post-Surgery Hospitalisation, approximately 14 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2020
  2. Study start12 May 2020
  3. Primary completion31 Jan 2023
  4. Study completion31 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04339023
Sponsor's protocol ID
2020-00099;qu19Ruppen
Acronym
OLP-POP
Status last verified
Aug 2023
First submitted
21 Mar 2020
Last updated
22 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34805194

Questions about this trial

What is this clinical trial studying?

A study testing treatment as usual in people with Postoperative Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in morphine consumption (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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04339023, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.

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