Evaluation of Open-Label Conditioned Placebo Analgesia for Postoperative Opioid Reduction Following Spinal Fusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2020-03-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This research aims to understand the impact of conditioned open label placebo (COLP) on opioid consumption and pain after surgery. The hypothesis being tested is that by pairing a non-deceptive placebo pill with regularly prescribed pain killers after surgery, will allow reduction in opioids taken while maintaining the same level of analgesia.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Does Preoperative Pain Medication Management Influence Surgical Outcomes in Spinal Fusion

NCT04095624

Opioid Use Spine Fusion

COMPLETED NA

Conditioned Open-label Placebo (COLP) for Peri-operative Pain Management in Patients With Head and Neck Cancer

NCT04973748

Postoperative Pain Opioid Use

COMPLETED NA

Oral Versus Intravenous Acetaminophen in Lumbar Spine Surgery

NCT07203079

Postoperative Pain

NOT_YET_RECRUITING PHASE4

Conditioning & Open-Label Placebo (COLP) for Opioid Management in Intensive Inpatient Rehabilitation

NCT05351333

Spinal Cord Injuries Polytrauma Burns

ACTIVE_NOT_RECRUITING NA

Reduction of Opioid Dose Using Conditioning & Open-Label Placebo (COLP) in Patients With Spinal Cord Injury, Polytrauma and Burn Injury

NCT03906721

Spinal Cord Injuries Polytrauma Burn Injury

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Participants will be enrolled at preoperative clinic.

Inclusion criteria:

1. aged 18-75 years
2. scheduled for spinal fusion surgery
3. able to comprehend and willingness to participate in COLP
4. willingness to undergo psychophysical and psychosocial testing
5. willingness to participate in long-term follow-up.

Exclusion criteria:

1. delirium, psychosis, or other cognitive impairment limiting completion of study procedures
2. non-English speaking
3. contraindication to opioid usage

Preoperative psychosocial and pain questionnaires will be completed using a secure email link to REDcap, and brief quantitative sensory testing performed.

After completion of preoperative testing, they will be randomized to one of 2 treatments: COLP or treatment as usual (TAU).

Day of surgery: Patient will undergo scheduled spinal fusion and admitted for post-operative recovery as per normal surgical management. No restrictions on intraoperative anesthetics or post-operative pain management options will be made. Intraoperative medication use, including opioids, as well as post-operative opioid consumption and pain scores will be extracted from the medical record.

Inpatient and outpatient postoperative period: The study investigator or research assistant (RA) will train the participant and nursing staff in the self-administration of COLP with each analgesic administration in hospital, beginning on POD 0, pairing one open label placebo pill with each analgesic medication administration. Beginning on POD 2, patients will additionally be instructed to take a scheduled placebo pill at least 3 times/day, and in conjunction with their ongoing instances of PRN opioid utilization. Opioid administration and pain scores will be recorded in a daily diary, which the RA will help fill out on POD1 and 2 with them. At hospital discharge, the patients' bottle of placebo pills will be replenished. Patients will be instructed to continue scheduled and PRN use of opioids, and encouraged to use placebo pills. After discharge, the number of placebo and opioid pills that they use, as well as average pain at rest and with movement each day will be collected for up to 21 days via email linking to Redcap system. If preferred, patients will answer questions through daily SMS TEXT or telephone call, using a secure study phone. To protect patient's privacy there will be no identifiable information in the text messages. The SMS texts will be sent from a dedicated study phone that is MobileIron enabled. MobileIron is software used by Partners HealthCare that allows for more secure data management.

Follow-up visit: At surgical follow-up visit, patients will repeat baseline testing and participants in the COLP group will undergo a 15-minute semi-structured interview to determine the patient's experience with managing post-operative pain with COLP. Long term follow-up on pain, psychosocial impact and opioid use will be accomplished using the Redcap email survey system.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spine Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

open label placebo

participants will take open label placebo pills TID and in conjunction with other PRN analgesics

Group Type ACTIVE_COMPARATOR

open label placebo

Intervention Type OTHER

open label placebo pill

treatment as usual

participants will take PRN analgesics as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

open label placebo

open label placebo pill

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

non-deceptive placebo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* (1) aged 18-75 years, (2) scheduled for spinal fusion surgery up to, and including 4 levels, (3) able to comprehend and willingness to participate in COLP, (4) willingness to undergo psychophysical and psychosocial testing (5) willingness to participate in long-term follow-up.