The Effectiveness of IV/PO Acetaminophen in the Perioperative Period in Reducing Opiate Use After Lumbar Spine Fusion

NCT03104816 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: HS-15-00615
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Fusion of Spine, Lumbar Region

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Postoperative Opioid Use

  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.

  Within 24 hours after surgery

Study Arms (3)

Acetaminophen IV Soln 10 MG/ML (A)

EXPERIMENTAL

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; Drug: Hydromorphone

PO acetaminophen (B)

EXPERIMENTAL

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; Drug: Hydromorphone

Hydromorphone (control arm) (C)

ACTIVE COMPARATOR

Patients in the control arm (Group C) will not receive acetaminophen for 24 hours.

Drug: Hydromorphone

Interventions

Acetaminophen IV Soln 10 MG/ML DRUG

Also known as: Ofirmev

Acetaminophen IV Soln 10 MG/ML (A)

Acetaminophen DRUG

Also known as: Tylenol

PO acetaminophen (B)

Hydromorphone DRUG

Also known as: Dilaudid

Acetaminophen IV Soln 10 MG/ML (A); Hydromorphone (control arm) (C); PO acetaminophen (B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA (American Society of Anesthesiologists) I-III patients scheduled for elective one or two level minimally invasive lumbar fusions

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Keck Hospital of USC

Los Angeles, California, 90033, United States

Location

Related Publications (4)

• Cakan T, Inan N, Culhaoglu S, Bakkal K, Basar 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.

  PMID: 18580346 BACKGROUND

• 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.

  PMID: 25766366 BACKGROUND

• 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.

  PMID: 20173643 BACKGROUND

• 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.

  PMID: 23887076 BACKGROUND

MeSH Terms

Conditions

Agnosia; Pain

Interventions

Acetaminophen; Hydromorphone

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

The trial was not completed and had very small amount of participants.

Results Point of Contact

• Title: Eugenia Ayrian
• Organization: USCalifornia

eayrian@med.usc.edu

8186363161

Study Officials

• Eugenia Ayrian

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Anesthesiology;Chief of Neuro Anesthesiology

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 7, 2017
• Study Start: October 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 8, 2019
• Results First Posted: October 8, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)