The Effectiveness of IV/PO Acetaminophen in the Perioperative Period in Reducing Opiate Use After Lumbar Spine Fusion
Condition: Fusion of Spine, Lumbar Region
Intervention: Acetaminophen IV Soln 10 MG/ML; Acetaminophen; Hydromorphone
Intervention MeSH terms: Acetaminophen; Hydromorphone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Acetaminophen po; Acetaminophen IV; Pain management; minimally invasive lumbar fusions; Ofirmev; Analgesics; Opioid; Pain; Postoperative; Spinal

Summary:

      Simple explanation and rationale:

      Recovery after spine surgery is usually accompanied by severe pain which has traditionally
      been managed with opioids. It is common practice to supplement opioid treatment with
      different classes of analgesics which work through alternative pain pathways and receptors in
      order to achieve an additive or synergistic effect while reducing the amount of opioids
      necessary for pain control.

      Acetaminophen can be a beneficial supplemental analgesic to opioids for postoperative pain
      relief.

      Intervention:

      Patients will be randomized to either the treatment with IV acetaminophen (A), PO
      acetaminophen (B), or hydromorphone control group (C).

      Objective/Purpose:

      Primary objective is to determine the impact of administering a supplemental non-opioid
      analgesic drug such as IV or PO acetaminophen on total opioid dose administered over the
      postoperative period.

      Secondary objectives include investigating the impact of IV/PO acetaminophen on the level of
      postoperative pain, patient satisfaction, and side effects secondary to opioids such as
      nausea, vomiting, pruritus, sedation, respiratory depression, ileus, and urinary retention,
      and PACU (postoperative care unit) discharge time.

      Study population:

      126 patients will be enrolled in the study (42 for group A, 42 for group B, and 42 for
      control group C).

      Follow-up and Endpoints / Outcomes:

      Postoperative assessments will be done at 0, 30, and 60 minutes, 6 hours, 12 hours and 24
      hours after surgery. Patients will be evaluated for pain (using a numeric rating scale),
      total opioid consumption, and for opioid side effects including drowsiness (using the Ramsey
      sedation scale and the Aldrete score at the time of arrival to and discharge from recovery
      room), respiratory depression, nausea, vomiting, and pruritus. Patient satisfaction will also
      be assessed using a numeric rating scale.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ASA (American Society of Anesthesiologists) I-III patients scheduled for elective one
             or two level minimally invasive lumbar fusions

        Exclusion Criteria:

          -  Patients requiring surgery for neoplastic processes

          -  Allergy to acetaminophen

          -  Liver dysfunction and elevated Liver Function Tests (LFTs)

          -  Alcohol or drug dependency

          -  Mental retardation

          -  Less than 50 kg of weight

          -  regnant women

          -  Patients requiring long-acting opioid pain management (including fentanyl patch,
             oxycontin, etc) for over 3 weeks immediately prior to surgery