Post-op Acetaminophen vs NSAID Use on Lumbar Spinal Fusion Outcomes

NCT02700451 | Completed Results DMC

• 1 other identifier: 2014-333
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergoing spine surgery often have considerable pain post-operatively and frequently require opioid medication (Percocet, Norco, oxycodone, morphine, etc.) to control their pain postoperatively. The widespread use of opioids, however, is associated with a number of side effects. These include: sedation, dizziness, nausea, vomiting, constipation, dizziness and itching amongst others. Some investigators have suggested that anti-inflammatory medications (the same class of medicines as advil, ibuprofen, etc.) and acetaminophen (Tylenol) can reduce the total dose of opioid required postoperatively and, as a result, lower opioid-related side effects. The purpose of this study is to test this hypothesis and determine if postoperative anti-inflammatory medications and postoperative acetaminophen can reduce the amount of opioid required to control pain following surgery. A secondary goal of this study is to examine if the change in pain medication will lead to decreased overall pain levels, decreased opioid-related side effects and improved function \[quicker ambulation with physical therapy (PT), earlier return to work, etc.\].

Conditions

Lumbar Osteoarthritis; Spondylosis; Lumbar Disc Disease; Spinal Stenosis

Keywords

IV acetaminophen; IV Ketorolac; Post-operative analgesia; Opioid use

Outcome Measures

Primary Outcomes (1)

• Perioperative Opioid Use

  Measure the impact of treatment on total opioid use during the hospital stay

  Hospital stay (2-4 days)

Secondary Outcomes (24)

• Opioid Use at 4-6 Weeks

  4-6 weeks

• Opioid Use at 3 Months

  3 months

• Opioid Use at 1 Year

  1 year

• Opioid Use at 2 Years

  2 years

• Numerical Pain Rating Scale

  1 days and 3 days

Study Arms (3)

Intravenous (IV) Placebo

PLACEBO COMPARATOR

IV Placebo arm

Drug: Placebo

IV Ketorolac

EXPERIMENTAL

IV Ketorolac arm

Drug: Ketorolac

IV Acetaminophen

EXPERIMENTAL

IV Acetaminophen arm

Drug: Acetaminophen

Interventions

Ketorolac DRUG

Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. Age 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.

Also known as: Toradol

IV Ketorolac

Acetaminophen DRUG

Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.

Also known as: Tylenol, Ofirmev

IV Acetaminophen

Placebo DRUG

Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.

Also known as: Normal Saline

Intravenous (IV) Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75
• Require 1 or 2 level lumbar spinal fusion through posterior or lateral approach
• No history of long term opioid use (daily or almost daily opioid use \> 2 weeks) and not on opiates at time of presentation to clinic

You may not qualify if:

• Documented allergy to NSAIDs or Acetaminophen
• History of: Peptic Ulcer Disease, Congestive heart failure, Chronic liver disease, Elevated alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) greater than 1.5 times control, Bleeding disorder, Renal dysfunction (Serum creatinine \> 1.5 mg/dL), Glucocorticoid use within 1 month of surgery
• Current smokers (quite date \< 30 days ago)
• Revision for pseudarthrosis
• Patients who are unable to physically or mentally provide consent to the study procedures.

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Spine; Spondylosis; Intervertebral disc disease; Spinal Stenosis

Interventions

Ketorolac; Ketorolac Tromethamine; Acetaminophen; Saline Solution

Condition Hierarchy (Ancestors)

Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Osteoarthritis; Arthritis; Joint Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Catherine Himo Gang
• Organization: HospitalSS

gangh@HSS.EDU

917-260-4603

Study Officials

• Catherine Himo Gang

  Research Manager for Spine Research

  STUDY DIRECTOR

• Harvinder Sandhu, MD

  Associate Professor of Orthopedic Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: March 7, 2016
• Study Start: March 1, 2016
• Primary Completion: December 31, 2021
• Study Completion: March 1, 2023
• Last Updated: July 10, 2023
• Results First Posted: July 10, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)