Low Back Pain
Conditions
Keywords
acetaminophen in transforaminal lumbar interbody fusion
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.
Interventions
DRUGAcetaminophen
1 gram of intravenous Acetaminophen
DRUGPlacebo 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
Sponsors
Texas Tech University Health Sciences Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS | Q4 x 24 hours averaged | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of 100% Sedation | 4-hr intervals for a 24-hr period averaged | Sedation will be measured on a scale of 1 to 5 at 4-hour intervals as follows: 1-completely awake; 2-awake but drowsy; 3 asleep, but responds to verbal commands; 4-asleep but responds to tactile stimuli; and 5-asleep and not responding to any stimuli. |
| Vital Signs | 4-hour intervals (+/- 30 minutes) for 24-hrs averaged | Routine postoperative vital signs will be collected at 4-hour intervals (+/- 30 minutes) postoperatively respiratory rate, oxygen saturation, mean arterial pressure, and heart rate. Any reports of headache, dizziness, nausea, vomiting, pruritis, agitation, constipation, insomnia, bradycardia (Heart rate below 60 beats per minute), hypotension (MAP less than 30% of baseline), or urinary retention will be recorded throughout the study and will be treated appropriately as they occur, and the treatment medication will be stopped if determined to be a causative factor. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total PCA Morphine | Duration of operation | Amount of morphine used during surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
Acetaminophen: 1 gram of intravenous Acetaminophen | 10 |
| 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
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 | 11 |
| Total | 21 |
Baseline characteristics
| Characteristic | Acetaminophen | PlaceboComparator | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 11 Participants | 21 Participants |
| Age, Continuous | 54.5 years | 54.0 years | 54.5 years |
| ASA score ASA 1 | 1 participants | 1 participants | 2 participants |
| ASA score ASA 2 | 6 participants | 5 participants | 11 participants |
| ASA score ASA 3 | 3 participants | 4 participants | 7 participants |
| decompressions 1 decompression | 9 Participants | 9 Participants | 18 Participants |
| decompressions 2 decompressions | 1 Participants | 2 Participants | 3 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 10 participants | 11 participants | 21 participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 11 |
| other Total, other adverse events | 0 / 10 | 0 / 11 |
| serious Total, serious adverse events | 0 / 10 | 0 / 11 |
Outcome results
Primary
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
Time frame: Q4 x 24 hours averaged
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Acetaminophen | VAS | 6 score on a scale |
| PlaceboComparator | VAS | 8.5 score on a scale |
Secondary
Level of 100% Sedation
Sedation will be measured on a scale of 1 to 5 at 4-hour intervals as follows: 1-completely awake; 2-awake but drowsy; 3 asleep, but responds to verbal commands; 4-asleep but responds to tactile stimuli; and 5-asleep and not responding to any stimuli.
Time frame: 4-hr intervals for a 24-hr period averaged
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acetaminophen | Level of 100% Sedation | 10 participants of 100% sedation |
| PlaceboComparator | Level of 100% Sedation | 11 participants of 100% sedation |
Secondary
Vital Signs
Routine postoperative vital signs will be collected at 4-hour intervals (+/- 30 minutes) postoperatively respiratory rate, oxygen saturation, mean arterial pressure, and heart rate. Any reports of headache, dizziness, nausea, vomiting, pruritis, agitation, constipation, insomnia, bradycardia (Heart rate below 60 beats per minute), hypotension (MAP less than 30% of baseline), or urinary retention will be recorded throughout the study and will be treated appropriately as they occur, and the treatment medication will be stopped if determined to be a causative factor.
Time frame: 4-hour intervals (+/- 30 minutes) for 24-hrs averaged
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acetaminophen | Vital Signs | 10 participants with 100% vitals completed |
| PlaceboComparator | Vital Signs | 11 participants with 100% vitals completed |
Other Pre-specified
Total PCA Morphine
Amount of morphine used during surgery
Time frame: Duration of operation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Acetaminophen | Total PCA Morphine | 41.6 mg |
| PlaceboComparator | Total PCA Morphine | 36.6 mg |