The Effectiveness of IV/PO Acetaminophen in the Perioperative Period in Reducing Opiate Use After Lumbar Spine Fusion
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|ClinicalTrials.gov Identifier: NCT03104816|
Recruitment Status : Terminated (Could not get an approval from Department Reviewer for the study continuation.)
First Posted : April 7, 2017
Results First Posted : October 8, 2019
Last Update Posted : October 8, 2019
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.
Patients will be randomized to either the treatment with IV acetaminophen (A), PO acetaminophen (B), or hydromorphone control group (C).
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Fusion of Spine, Lumbar Region||Drug: Acetaminophen IV Soln 10 MG/ML Drug: Acetaminophen Drug: Hydromorphone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effectiveness of IV/PO Acetaminophen in the Perioperative Period in Reducing Opiate Use After Lumbar Spine Fusion: a Prospective, Randomized Controlled Trial|
|Study Start Date :||October 2016|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||December 2017|
Experimental: Acetaminophen IV Soln 10 MG/ML (A)
Patients in group A will receive 1 g of IV acetaminophen 15 minutes prior to wound incision, and every 4 to 6 hours postoperatively for a total of 4 grams in 24 hours.
Drug: Acetaminophen IV Soln 10 MG/ML
Other Name: Ofirmev
Other Name: Dilaudid
Experimental: PO acetaminophen (B)
Patients in group B will receive 1 g of PO acetaminophen prior to surgery, and 1 g of oral acetaminophen every 4 to 6 hours postoperatively for a total of 4 grams in 24 hours.
Other Name: Tylenol
Other Name: Dilaudid
Active Comparator: Hydromorphone (control arm) (C)
Patients in the control arm (Group C) will not receive acetaminophen for 24 hours.
Other Name: Dilaudid
- Postoperative Opioid Use [ Time Frame: Within 24 hours after surgery ]Determine the impact of administering a supplemental non-opioid analgesic drug such as IV/oral acetaminophen on total opioid dose administered over the perioperative period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104816
|United States, California|
|Keck Hospital of USC|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Eugenia Ayrian||University of Southern California|