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

Sponsor:

Information provided by (Responsible Party):

Eugenia Ayrian, University of Southern California

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Fusion of Spine, Lumbar Region	Drug: Acetaminophen IV Soln 10 MG/ML Drug: Acetaminophen Drug: Hydromorphone	Phase 4

Show detailed description

Detailed Description:

Simple explanation and rationale:

Recovery after spine surgery, especially spinal fusion surgery, is usually accompanied by severe pain which has traditionally been managed with opioids. While opioids have been proven effective, they are associated with undesirable side effects including nausea, vomiting, pruritus, sedation, respiratory depression, ileus, and urinary retention leading to increased time required in recovery and a decrease in patient satisfaction. For this reason, 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 is a centrally-acting cyclooxygenase inhibitor nonsteroidal anti-inflammatory medication that has minimal, if any, gastrointestinal and platelet-inhibiting side effects, and is better tolerated by patients than other cyclooxygenase inhibitors. This medication can be a beneficial supplemental analgesic to opioids for postoperative pain relief. Previously conducted studies demonstrate a rationale for the use of intravenous/PO acetaminophen in a multimodal analgesic regimen to reduce postoperative analgesia.

Intervention:

Patients will be randomized to either the treatment with IV acetaminophen (A), PO acetaminophen (B), or hydromorphone control group (C). Patients who are randomized to group A will receive 1 g of IV acetaminophen during the wound closure and every 4 to 6 hours postoperatively for a total of 4 g in 24 hours. Patients who are randomized to group B will receive 1 g of PO acetaminophen before surgery and every 4 to 6 hours postoperatively for a total of 4 g in 24 hours. Patients who are randomized to control group C will not receive acetaminophen. Post-operatively, patients in both groups will also receive IV hydromorphone PCA (patient-controlled analgesia) only for 24 hours for pain.

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.

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:

Statistics:

All sample size calculations with reference to:

Specific Aim 1 reduction of opioid intake by at least 25% between the Control (Group C) and Intervention Groups A and B, and
Specific Aim 2 improvement of Pain Score by at least 25% between the Control (Group C) and the Intervention Groups A and B,

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	28 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Hydromorphone hydrochloride Acetaminophen Hydromorphone

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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 Drug: Hydromorphone 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.	Drug: Acetaminophen Other Name: Tylenol Drug: Hydromorphone Other Name: Dilaudid
Active Comparator: Hydromorphone (control arm) (C) Patients in the control arm (Group C) will not receive acetaminophen for 24 hours.	Drug: Hydromorphone Other Name: Dilaudid

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Information from the National Library of Medicine

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

Locations

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United States, California
Keck Hospital of USC
Los Angeles, California, United States, 90033

Sponsors and Collaborators

University of Southern California

Investigators

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Principal Investigator:	Eugenia Ayrian	University of Southern California

Study Documents (Full-Text)

Documents provided by Eugenia Ayrian, University of Southern California:

Study Protocol and Statistical Analysis Plan [PDF] March 28, 2016

More Information

Publications:

Cakan T, Inan N, Culhaoglu S, Bakkal K, Başar H. Intravenous paracetamol improves the quality of postoperative analgesia but does not decrease narcotic requirements. J Neurosurg Anesthesiol. 2008 Jul;20(3):169-73. doi: 10.1097/ANA.0b013e3181705cfb.

Devin CJ, McGirt MJ. Best evidence in multimodal pain management in spine surgery and means of assessing postoperative pain and functional outcomes. J Clin Neurosci. 2015 Jun;22(6):930-8. doi: 10.1016/j.jocn.2015.01.003. Epub 2015 Mar 9. Review.

Korkmaz Dilmen O, Tunali Y, Cakmakkaya OS, Yentur E, Tutuncu AC, Tureci E, Bahar M. Efficacy of intravenous paracetamol, metamizol and lornoxicam on postoperative pain and morphine consumption after lumbar disc surgery. Eur J Anaesthesiol. 2010 May;27(5):428-32. doi: 10.1097/EJA.0b013e32833731a4.

Garcia RM, Cassinelli EH, Messerschmitt PJ, Furey CG, Bohlman HH. A multimodal approach for postoperative pain management after lumbar decompression surgery: a prospective, randomized study. J Spinal Disord Tech. 2013 Aug;26(6):291-7. doi: 10.1097/BSD.0b013e318246b0a6.

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Responsible Party:	Eugenia Ayrian, Associate Professor of Clinical Anesthesiology;Chief of Neuro Anesthesiology, University of Southern California
ClinicalTrials.gov Identifier:	NCT03104816
Other Study ID Numbers:	HS-15-00615
First Posted:	April 7, 2017 Key Record Dates
Results First Posted:	October 8, 2019
Last Update Posted:	October 8, 2019
Last Verified:	September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
Plan Description:	The data will kept for a minimum of 3 years after the study is completed. All documents containing identifiers will be shredded. Electronic documents will be deleted.

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No
Product Manufactured in and Exported from the U.S.:	No

Keywords provided by Eugenia Ayrian, University of Southern California:


Acetaminophen po Acetaminophen IV Pain management minimally invasive lumbar fusions Ofirmev	Analgesics Opioid Pain Postoperative Spinal

Additional relevant MeSH terms:

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Acetaminophen Hydromorphone Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents	Physiological Effects of Drugs Antipyretics Analgesics, Opioid Narcotics Central Nervous System Depressants

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