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Open-Label Placebo Treatment for Acute Postoperative Pain (OLP-POP)

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Open-Label Placebo

treatment as usual

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring postoperative pain, Open-Label Placebo, morphine, Transforaminal Lumbar Interbody Fusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital of Basel, Department of Anesthesia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

OLP-Group

TAU-group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

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"

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"

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

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

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

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

Full Information

NCT ID

NCT04339023

First Posted

March 21, 2020

Last Updated

August 21, 2023

Sponsor

University Hospital, Basel, Switzerland

1. Study Identification

Unique Protocol Identification Number

NCT04339023

Brief Title

Open-Label Placebo Treatment for Acute Postoperative Pain

Acronym

OLP-POP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

May 12, 2020 (Actual)

Primary Completion Date

January 31, 2023 (Actual)

Study Completion Date

January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OLP-Group

Arm Type

Experimental

Arm Description

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

Arm Title

TAU-group

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Open-Label Placebo

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

treatment as usual

Intervention Description

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 Outcome Measure Information:

Title

Difference in morphine consumption

Description

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 Outcome Measure Information:

Title

Difference in morphine request rates

Description

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)

Title

Difference in pain intensity at rest

Description

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)

Title

Difference in pain intensity while walking

Description

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.

Title

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

Description

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

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

Title

Difference in requested rescue analgesics

Description

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

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)

Title

Opioid-Related Side Effects

Description

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

Time Frame

Title

Length of Post-Surgery Hospitalisation

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wilhelm Ruppen, Prof. Dr.

Organizational Affiliation

University Hospital of Basel, Department of Anesthesia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jens Gaab, Prof. Dr.

Organizational Affiliation

University of Basel,Faculty of Psychology

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of Basel, Department of Anesthesia

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

34805194

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.

Results Reference

derived

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Open-Label Placebo Treatment for Acute Postoperative Pain

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