Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Treatment in Spinal Surgery
- Registration Number
- NCT05764707
- Lead Sponsor
- Massachusetts General Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Patients undergoing 1-2 levels primary spine surgery ≥18 years old
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intravenous Placebo Placebo Intravenous normal saline will be administered within 30 minutes of skin closure. Intravenous Acetaminophen Acetaminophen Intravenous acetaminophen (1000mg) will be administered within 30 minutes of skin closure.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Time to rescue analgesia Postoperatively until discharge, an average of two days The time to rescue analgesia (in minutes) will be assessed.
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.
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.
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States