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

NCT ID: NCT02061774

Last Updated: 2020-05-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2018-01-11

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.

Detailed Description

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. The advantages of intravenous acetaminophen are well known in the literature and its opioid-sparing effects have been documented in multiple surgical studies.

Multimodal regimens are now being advocated in the literature to decrease opioid use (8, 23). This is especially significant in spine surgery patients who often have chronic pain requiring long-term use of these habit-forming drugs as well as in patients who may not be able to tolerate opiods due to health status.

To our knowledge there are no studies done in the U.S. on the opioid sparing and pain reducing effects of intravenous acetaminophen on patients undergoing elective minimally invasive 1 or 2 level transforaminal lumbar interbody fusion. Investigating intravenous acetaminophen, particularly its pain reducing and opioid sparing effects, may give surgeons another medication for use in a multimodal approach to pain.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

acetaminophen

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

Group Type: ACTIVE_COMPARATOR

Acetaminophen

Intervention Type: DRUG

1 gram of intravenous Acetaminophen

PlaceboComparator

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

Group Type: PLACEBO_COMPARATOR

Placebo comparator

Intervention Type: 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

Interventions

Acetaminophen

1 gram of intravenous Acetaminophen

Intervention Type: DRUG

Placebo comparator

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

Intervention Type: DRUG

Other Intervention Names

Tylenol; placebo

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Texas Tech University Health Sciences Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Felton, MD

Role: PRINCIPAL_INVESTIGATOR

TTUHSC department of Surgery

Locations

Texas Tech University Health Science Center

Lubbock, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

L14-015

Identifier Type: -

Identifier Source: org_study_id