Towards Enhanced Recovery After Cesarean
Condition: Cesarean Section Complications
Study type: Interventional
Phase: Early Phase 1

Summary: 
      One in 300 women will become persistent opioid users after cesarean delivery (1). Cesarean
      delivery is the most common surgical procedure in the United States, representing 31.9% of
      the 3,788,235 deliveries in 2018 (2). Patients have to cope with the pain and challenges of
      post-operative care while adjusting to motherhood and completing activities of daily living.
      Often when they return home, they are also tasked with other domestic roles which compounds
      the challenge of this post-operative period. With a potential impact just in the US on 1.2
      million mothers each year, optimizing post-operative pain management in order to reduce the
      risk of persistent opioid use represents an urgent unmet public health goal. To this end,
      there are national efforts to reduce the cesarean rate and optimize post-cesarean pain
      management (3,4). The majority of efforts in the last few years have focused on home-going
      medications and alterations in prescription practices. Recent recommendations from the
      Enhanced Recovery After Surgery Society indicate that patients should receive multi-modal
      analgesia on a regular basis, along with early post-delivery mobilization (3). However, the
      efficacy of scheduled non-steroidal anti-inflammatory medications (NSAID) along with
      acetaminophen in the immediate post-operative period and after going home have not been
      systematically studied in the cesarean population. We hypothesize that patients who receive
      scheduled medications in the post-operative period are less likely to require opioids for
      pain relief both in the hospital and after they return home.
    

Detailed description: 
      The proposed study is a pragmatic randomized control trial of post-cesarean pain management
      techniques with participants allocated in a 1:1 ratio using a random block allocation table
      using blocks of size 4 and 6. Given the nature of the study, it would be impossible to blind
      participants and clinicians. Participants will be randomized after completion of the
      procedure to ensure that patients who have significant surgical complications such as severe
      hemorrhage or those undergoing hysterectomy are excluded.

      All participants will receive intrathecal morphine 150mcg per OU standard of care, with
      orders for pain management per anesthesia for the first 24 hours with a regular diet, removal
      of urinary catheter 12-24 hours post-operatively, and abdominal binder placed after surgery.
      In addition, patients will be provided with a fitness tracker to be worn on their wrist
      throughout hospitalization and until their post-operative visit. After 24 hours, participants
      will be assigned to either receive current OU standard of care therapy which includes
      ibuprofen 800mg every eight hours as needed (PRN), acetaminophen 1000mg every eight hours
      PRN, and oxycodone five mg every six hours PRN or the study protocol. The study protocol will
      include scheduled ibuprofen 800mg every eight hours and acetaminophen 1000mg every eight
      hours, given at the same time, along with oxycodone five mg every six hours PRN for
      breakthrough pain. Both sets of patients will be provided with 60 pills of acetaminophen
      500mg and 30 pills ibuprofen 800mg to take at home, with the study participants receiving
      instructions to take the medications in a scheduled fashion and the other group in an as
      needed fashion. Both groups will receive a discharge prescription for 20 pills of oxycodone
      five mg every 6 hours PRN to be taken for breakthrough pain as needed--current standard at
      OU. All prescriptions will be delivered to the patient from the pharmacy prior to discharge
      per our departmental standard. Patient requiring more medications to control pain beyond the
      randomized approach described above will be treated per the discretion of the attending
      physician or designee. Patients will be seen for a post-operative care visit on post
      discharge day 8-12 depending on patient and clinic availability and asked to bring their
      fitness tracker and medication bottles with them for assessment of steps taken, medication
      consumed, pain outcomes and satisfaction scores. The Oklahoma PMP Aware system will be
      accessed to record prescriptions for controlled substances from other providers.
    

Intervention name(s): Ibuprofen, acetaminophen, oxycodone
Intervention type(s): Drug
Intervention description(s): The timing of medications is the intervention.
Intervention MeSH terms: Acetaminophen; Ibuprofen; Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research