Patient-Driven Analgesic Protocol Selection for Post-Cesarean Pain Management
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The ability to predict pain and then apply modified treatment protocols has been limited.
      Current practice is for physicians to select standard post-operative pain treatment protocols
      without patient consultation. This study hopes to determine if patient's involvement in
      analgesic drug/dosage selection can optimize pain relief while minimizing related side
      effects. This could result in a more patient-centered care model and individualized
      perioperative analgesic treatment protocols based on patient's preferences, needs and
      expectations.
    

Detailed description: 
      This randomized, controlled study will include a simple, preoperative questionnaire to obtain
      baseline demographic and obstetric data; and complete questions (that have previously been
      shown to be predictive of postoperative pain) from which we will determine their expected and
      target postoperative pain scores. These questionnaires should take less than 3-4 minutes to
      complete.

      The subject will then be randomized into "choice" and "no choice" groups. The randomization
      for choice vs. no choice will be at a 1:3 ratio i.e. 1 woman will get no choice and 3 will
      get a choice for their analgesic protocol. All women will receive the same medications for
      intraoperative anesthetic management -- only the postoperative pain medications will be
      altered.

      The no choice group will receive the current standard analgesic protocol: medium dose
      intrathecal morphine, and around the clock acetaminophen po q6h and ibuprofen po q6h.

      The group with the choice will be offered 3 different protocols:

      1. low dose intrathecal morphine, and around the clock acetaminophen po q6h and ibuprofen po
      q6h. 2 medium dose intrathecal morphine, and around the clock acetaminophen po q6h and
      ibuprofen po q6h. 3. high dose intrathecal morphine, and around the clock acetaminophen po
      q6h and ibuprofen po q6h, as well as gabapentin po one time within 1 hr of delivery.

      Women randomized to the "choice" group will select a protocol after being given a standard
      script explaining advantages and disadvantages of each protocol.

      Drugs and doses utilized in the study are safe for postpartum women and within dose range
      routinely used at our and other institutions.

      All breakthrough pain will be managed the same for all patients, and adequate analgesia will
      be available to treat post-operative pain.

      Primary breakthrough rescue analgesic will be our standard oral opioid oxycodone managed
      using our current treatment algorithm. If pain 1-4 out of 10, 1 tablet (5 mg) will be
      offered, if pain >4 out of 10, 2 tablets (10 mg) will be offered PRN. Pain not responding to
      oral opioids will be offered IV morphine boluses or PCA as per standard treatment protocols.
      Additional analgesic options (e.g. TAP blocks) will also be available as per standard care.

      Following standard Cesarean delivery, postoperative data will be collected (directly from
      patients and from the electronic medical record) by study investigators blinded to group
      assignment.

      Outcome measures:

        1. Pain scores at rest and on to sitting (VPS 0-10) collected at 3, 6, 12, 24, 36, 48 hours
           post-cesarean

        2. Overall daily pain score and its deviation from target and expected pain score will be
           determined at 0-24 and >24-48 hours study periods.

        3. Opioid use (oral and IV morphine) in the 0-24 and >24-48 hour study periods.

        4. Time to first analgesic for breakthrough pain (minutes from spinal)

        5. Side effect: Pruritus score (0-100), nausea score (0-100) and number of episodes of
           vomiting for the 0-24 and >24-48 hour post- operative periods

        6. Any treatment of pruritus and/or nausea/vomiting

        7. Satisfaction with postoperative analgesia score (0-100)

        8. Discharge time (hours/minutes from surgery end)

      Telephone follow-up for pain score, opioid use, and functional recovery will be performed at
      1 week, 1 month, 3 months and 6 months post-Cesarean. The telephonic questions will last 3-4
      minutes
    

Intervention name(s): No choice given; Choice given; Ibuprofen; Acetaminophen; Gabapentin; Morphine (low); Morphine (med); Morphine (high)
Intervention type(s): Other; Other; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Patients are randomized to getting a choice or not getting a choice. If they do not get a choice, they receive standard dose.; Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.; Ibuprofen 600mg po q6h; Acetaminophen 650mg po q6h; Gabapentin 600mg po one time within 1 hour of delivery; Intrathecal morphine dose 50mcg; Intrathecal morphine dose 150mcg; Intrathecal morphine 300mcg
Other intervention name(s): Low dose morphine; Medium dose morphine; High dose morphine
Intervention MeSH terms: Acetaminophen; Ibuprofen; Morphine; Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cesarean; postoperative pain; patient choice