Postoperative Opioid Use and Pain Scores in Patients Undergoing Transforaminal Lumbar Interbody Fusion

NCT02061774 | Terminated Phase 4 Results

• 1 other identifier: L14-015
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to study the effects of preoperative followed by scheduled intravenous acetaminophen on pain control for 24 hours postoperatively after minimally invasive 1 or 2 level transforaminal lumbar interbody fusion.

Conditions

Low Back Pain

Keywords

acetaminophen in transforaminal lumbar interbody fusion

Outcome Measures

Primary Outcomes (1)

• VAS

  The Visual Analogue Scale (VAS) and Verbal Rating Scale (VRS) will be measured at 4 hour intervals for a 24-hr period - measures of pain intensity in clinical and research settings. 0-10 Numeric pain intensity scale. 0 is no pain, 5 is moderate pain, and 10 is worst possible pain

  Q4 x 24 hours averaged

Secondary Outcomes (2)

• Level of 100% Sedation

  4-hr intervals for a 24-hr period averaged

• Vital Signs

  4-hour intervals (+/- 30 minutes) for 24-hrs averaged

Other Outcomes (1)

• Total PCA Morphine

  Duration of operation

Study Arms (2)

acetaminophen

ACTIVE COMPARATOR

1g intravenous acetaminophen over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours; maximum dose of 4 grams in 24 hours

Drug: Acetaminophen

PlaceboComparator

PLACEBO COMPARATOR

Placebo Comparator 0.9% NaCl 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours

Drug: Placebo comparator

Interventions

Acetaminophen DRUG

1 gram of intravenous Acetaminophen

Also known as: Tylenol

acetaminophen

Placebo comparator DRUG

placebo comparator .9% NaCl (sodium chloride) 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours

Also known as: placebo

PlaceboComparator

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years old
• Being scheduled to have elective primary minimally invasive 1 or 2 level transforaminal lumbar laminectomy interbody fusion
• ASA I, II, or III
• Informed consent form signed

You may not qualify if:

• Anyone weighing less than 50kg (as this would require a dosing change).
• Hypersensitivity or contraindication to intravenous acetaminophen or opioids
• Allergy to Methocarbamol; morphine sulfate, sevoflourane, or fentanyl
• Impairment of liver function-- defined as the inability to receive intravenous acetaminophen without dose adjustment as determined by the investigator; or history of chronic liver disease defined as history of hepatitis of any kind as recorded in the patient's chart
• Mental retardation recorded as a diagnosis in the patient's chart
• History of chronic pain (defined as currently receiving treatment from a specialist for pain)
• History of pain recalcitrant to intravenous morphine
• Impaired kidney function (defined as creatinine \> 1.5)
• Anyone who is not a candidate for general anesthesia or any other portion of the investigator's standard of

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Science Center

Lubbock, Texas, 79430, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

Early Termination due to preliminary analysis showed not clinically significant

Results Point of Contact

• Title: Cathy Lovett
• Organization: TTUHSC CRI

cathy.lovett@ttuhsc.edu

806-743-4222

Study Officials

• Jason Felton, MD

  TTUHSC department of Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: February 13, 2014
• Study Start: October 1, 2013
• Primary Completion: January 11, 2018
• Study Completion: January 11, 2018
• Last Updated: May 6, 2020
• Results First Posted: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)