Open-Label Placebo Treatment for Acute Postoperative Pain

NCT04339023 | Completed

• 1 other identifier: 2020-00099;qu19Ruppen
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

postoperative pain; Open-Label Placebo; morphine; Transforaminal Lumbar Interbody Fusion

Outcome Measures

Primary Outcomes (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)

  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)

• Difference in morphine request rates

  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

  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

  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.

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

  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

• Difference in requested rescue analgesics

  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)

Study Arms (2)

OLP-Group

EXPERIMENTAL

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

Drug: Open-Label Placebo

TAU-group

OTHER

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

Other: treatment as usual

Interventions

Open-Label Placebo DRUG

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

OLP-Group

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)

TAU-group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent
• Scheduled to receive a TLIF procedure at University Hospital Basel (USB)
• years or older
• German speaking
• Able to understand the study and its outcome measures

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital of Basel, Department of Anesthesia

Basel, 4031, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 34805194 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

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

Study Officials

• Wilhelm Ruppen, Prof. Dr.

  University Hospital of Basel, Department of Anesthesia

  PRINCIPAL INVESTIGATOR

• Jens Gaab, Prof. Dr.

  University of Basel,Faculty of Psychology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2020
• First Posted: April 8, 2020
• Study Start: May 12, 2020
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: August 22, 2023

Record last verified: 2023-08

Locations

CH (1)