Evaluation of Open-Label Conditioned Placebo Analgesia for Postoperative Opioid Reduction Following Spinal Fusion
Condition: Spine Surgery
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): open label placebo
Intervention type(s): Other
Intervention description(s): open label placebo pill
Other intervention name(s): non-deceptive placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: open label placebo