A Multimodal Analgesia Protocol Adapted for Ambulatory Surgery
Condition: Opioid Use
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this trial is to determine whether the combination of three
      non-opioid analgesics (multimodal analgesia) can significantly reduce or eliminate the need
      for opioids after ambulatory surgery.

      A secondary objective would be to present credible data for insurance providers about the
      opioid sparing effect of these medications. This data may encourage insurance providers to
      support payment for short term use of certain analgesics that currently require prior
      authorization.
    

Detailed description: 
      Prescription opioids are associated with addiction and accidental overdose, yet they continue
      to be the most commonly prescribed analgesics after ambulatory surgery.

      Multimodal analgesia is a promising alternative to opioids. It is based on the theory that a
      combination of more than one analgesic (with non-opioid mechanisms of action) can provide
      pain relief equal to or exceeding that of traditional opioids.

      Multimodal analgesia is not associated with opioid related side effects such as respiratory
      depression, nausea, constipation, and itching.

      Implementation of multi-modal analgesia in an ambulatory setting is challenging for a number
      of reasons.

      First, patient compliance with multiple medications and complex dosing schedules is poor.

      Second, misinformation still exists about the dosing of acetaminophen and NSAIDS
      (non-steroidal anti-inflammatory drugs). For example, many patients and health care providers
      believe that acetaminophen and NSAIDS cannot be taken concurrently. As a result, the additive
      analgesic effect of combining these drugs is not achieved.

      Finally, some medications used for multimodal analgesia can be difficult to procure in the
      ambulatory setting. For example, pregabalin (trade name Lyrica) has been used successfully to
      treat acute pain and reduce opioid requirements after surgery. However, its mechanism of
      action is similar to that of gabapentin (an older and less expensive drug) and insurers are
      reluctant to approve its use over the expensive alternative.

      Although gabapentin is a useful analgesic for chronic pain, its delayed onset of activity and
      unpredictable blood levels after oral administration make it impractical to use in the
      setting of acute pain. In fact, optimal dosing of gabapentin may require several days or
      weeks to establish.By contrast, pregabalin has a rapid onset of action with consistent and
      predictable plasma levels after oral administration.

      For this trial, patients in the control group would receive traditional postoperative pain
      medication consisting of a combination of oxycodone and acetaminophen (trade name Percocet)
      as needed at 4-6 hour intervals.

      Patients in the study group would receive the following:

        -  Three non-opioid pain medications (acetaminophen,celecoxib, and pregabalin) would be
           taken concurrently at six hour intervals for a period of 7 days.

        -  These three non-opioid medications (acetaminophen, celecoxib, and pregabalin ) would be
           provided in a "blister pack". All scheduled pain medication for a given 6 hour interval
           would be contained in a single compartment to simplify compliance for the patient. Study
           patients would also have access to oxycodone as a "rescue medication".

      The principles of postoperative pain management addressed in this protocol are supported by
      existing literature.

        1. Patient compliance with complex medication dosing protocols may be improved using
           calender and time based "blister packs".

        2. Pain control using combined acetaminophen and NSAID is superior to that either drug in
           isolation

        3. Pregabalin can reduce opioid requirements and opioid related nausea when treating acute
           pain.

      The primary objective of this trial is to determine whether the combination of three
      non-opioid analgesics (multimodal analgesia) can significantly reduce or eliminate the need
      for opioids after ambulatory surgery.

      A secondary objective would be to present credible data for insurance providers about the
      opioid sparing effect of these medications. This data may encourage insurance providers to
      support payment for short term use of certain analgesics that currently require prior
      authorization.
    

Intervention name(s): Celecoxib; Acetaminophen; Pregabalin; Oxycodone; Percocet
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Celecoxib 100mg; Acetaminophen 325mg; Pregabalin 50 mg; oxycodone 5-10 mg; Percocet (oxycodone 5mg/acetaminophen 325 mg)
Other intervention name(s): Celebrex; Paracetamol; Lyrica; Xtampza ER, Oxaydo, Roxicodone; Oxycodone / Paracetamol
Intervention MeSH terms: Acetaminophen; Celecoxib; Pregabalin; Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment