Use of On-Q Pump for Pain Post C-Section
Condition: Pain
Intervention: Ropivacaine 0.1%; Ropivacaine 0.2%; Normal saline; On-Q ® elastomeric pump
Intervention description: Ropivacaine 0.1% is a local anaesthetic drug and will be administered as a single bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump. The bolus dose of 8ml of 0.1% ropivacaine will be administered via a multiport, silver-impregnated catheter (6-10cm) placed above the rectus muscle parallel to the fascial incision, using a preloaded syringe. The infusion will be delivered by the On-Q® elastomeric pump pre-set to deliver 8ml/hr of 0.1% ropivacaine for 72 hours post-operatively.; Ropivacaine 0.2% is a local anaesthetic drug and will be administered as a single bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump. The bolus dose of 8ml of 0.2% ropivacaine will be administered via a multiport, silver-impregnated catheter (6-10cm) placed above the rectus muscle parallel to the fascial incision, using a preloaded syringe. The infusion will be delivered by the On-Q® elastomeric pump pre-set to deliver 8ml/hr of 0.2% ropivacaine for 72 hours post-operatively.; Normal saline will be administered as a single bolus dose of 8ml of normal saline followed by an infusion of normal saline using the On-Q® elastomeric pump. The bolus dose of 8ml of normal saline will be administered via a multiport, silver-impregnated catheter (6-10cm) placed above the rectus muscle parallel to the fascial incision, using a preloaded syringe. The infusion will be delivered by the On-Q® elastomeric pump pre-set to deliver 8ml/hr normal saline for 72 hours post-operatively.; The On-Q® elastomeric pump automatically and continuously delivers a regulated flow of 0.1% or 0.2% ropivacaine or normal saline locally to the surgical site for 72 hours post-operatively. The infusion will be delivered by pre-setting the On-Q® elastomeric pump to deliver at the rate of 8ml/hr for 72 hours post-operatively.
Intervention MeSH terms: Ropivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 64.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Analgesia; Cesarean section; Opiates

Summary:

      The main purpose of this study is to examine if pain levels treated with intrathecal (IT)
      preservative-free morphine (PFM) after a cesarean section improve with the additional use of
      continuous subfascial wound infiltration with ropivacaine using the OnQ® elastomeric pump
      system.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Female patients at Emory University Hospital Midtown undergoing non-emergent,
             scheduled or unscheduled first, second or third Cesarean sections

          2. Patients who are American Society of Anesthesiology (ASA) Class I-III

          3. Patients are at least 34 weeks pregnant

          4. Patients to receive spinal anesthesia for their procedure

          5. Patients who are 18 years of age or older

          6. Patient willing and able to provide written informed consent

        Exclusion Criteria:

          1. Patients with 3 or more prior Cesarean sections

          2. Patients undergoing emergent cesarean section with or without general anesthesia

          3. Patients with known allergy to morphine, ketorolac, and/or amide local anesthetics

          4. Patients who will not receive spinal anesthesia

          5. Patients who are less than 34 weeks pregnant

          6. Patients with significant maternal cardiac, liver or renal disease

          7. Patients with maternal history of narcotic abuse or dependency

          8. Patient with pre-operative fever (>100.4 degrees F)

          9. Patients less than 18 years old