Lumbar; Injury
Conditions
Brief summary
Spinal surgeries are generally associated with intense pain in the postoperative period, especially for the initial few days. The aim of this study is to examine the effect of intraoperative intravenous acetaminophen in spine surgery on postoperative analgesic requirements, pain scores, patient satisfaction, and clinical recovery. Enrolled patients are randomized to receive either intravenous acetaminophen or placebo at the time of surgical closure. It is hypothesized that patients receiving intravenous acetaminophen will have improved pain scores, require less opiate medication, and have better patient satisfaction than those receiving placebo.
Interventions
DRUGAcetaminophen
Patients will received 1000mg of intravenous acetaminophen within 30 minutes of skin closure.
DRUGPlacebo
Patients will received 1000mg of normal saline within 30 minutes of skin closure.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing 1-2 levels primary spine surgery ≥18 years old
Exclusion criteria
* Chronic opiate users * More than 3 levels or revision spine surgery * Liver disease patients include elevated LFT, hepatitis A, hepatitis B or hepatitis C, cirrhosis, fatty liver disease, and any other liver diseases caused by drugs, poisons, or alcohol(s) * Allergy/hypersensitivity to acetaminophen * Patients that have used acetaminophen during the 24 hours before their scheduled surgery Subjects who were unable to communicate in English were further excluded because of their inability to complete the postoperative questionnaires
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Worst pain score in the post-anesthesia care unit | Time of postoperative care unit discharge readiness, approximately 3 hours | The primary outcome will assess worst pain score at the time the patient is ready for post anesthesia care unit discharge using the Revised American Pain Society Patient Outcome Questionnaire. This scale ranges from 0 to 10, with higher values reporting more pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain scores | Postoperatively until 72 hours or discharge, approximately three days | Pain scores will be collected for the first 72 hours or up until discharge, whichever comes first, using clinically documented nursing pain scores. Values will be collected on a scale from 0 to 10 with higher values indicating increased (worst) pain. |
| Intraoperative opioid consumption | Intraoperatively | Total cumulative morphine equivalents will be reported while the patient is in the operating room. |
| Postoperative opioid consumption in the post anesthesia care unit | Postoperatively until time of PACU discharge, approximately 3 hours. | Total cumulative morphine equivalents will be reported while the patient is in the post anesthesia care unit. |
| Postoperative opioid consumption after discharge from the postoperative care | Time of discharge from the postoperative care unit until discharge from the hospital, an average of two days | Total cumulative morphine equivalents will be reported starting from the time the patient is discharged from the post anesthesia care unit until they are discharged from the hospital. |
| Time to rescue analgesia | Postoperatively until discharge, an average of two days | The time to rescue analgesia (in minutes) will be assessed. |
| Patient satisfaction | Time of postoperative care unit discharge readiness, approximately 3 hours. | Satisfaction with the patient's pain treatment in the hospital will be assessed at the time the patient is ready for discharge from the post anesthesia care unit using the Revised American Pain Society Patient Outcome Questionnaire. This scale ranges from 0 (extremely dissatisfied) to 10 (extremely satisfied). |
| Length of hospital stay | Postoperatively until discharge, an average of two days | Length of hospital stay (in days) will be reported. |
Countries
United States
Outcome results
None listed