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Completed

NCT Number: NCT04339023

Open-Label Placebo Treatment for Acute Postoperative Pain

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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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Basel, Department of Anesthesia

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open-label placebo

Drug

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

Treatment as Usual

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)

Primary outcomes

  1. 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)

    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)

Secondary outcomes

  1. Difference in morphine request rates

    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)

    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)

  2. Difference in pain intensity at rest

    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)

    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"

  3. Difference in pain intensity while walking

    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.

    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"

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

    Time frame: 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

    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

  5. Difference in requested rescue analgesics

    Time frame: 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)

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

  6. Opioid-Related Side Effects

    Time frame: 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)

    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

  7. Length of Post-Surgery Hospitalisation

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

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: OLP-POP

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 8, 2020
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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