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Completed

NCT Number: NCT05764707

Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Treatment in Spinal Surgery

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.

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Key information

Conditions

Lumbar; Injury Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetaminophen

Drug

Patients will received 1000mg of intravenous acetaminophen within 30 minutes of skin closure.

Other names: Tylenol

Placebo

Drug

Patients will received 1000mg of normal saline within 30 minutes of skin closure.

Other names: Normal Saline

Primary outcomes

  1. Worst pain score in the post-anesthesia care unit

    Time frame: 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 outcomes

  1. Postoperative pain scores

    Time frame: 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.

  2. Intraoperative opioid consumption

    Time frame: Intraoperatively

    Total cumulative morphine equivalents will be reported while the patient is in the operating room.

  3. Postoperative opioid consumption in the post anesthesia care unit

    Time frame: 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.

  4. Postoperative opioid consumption after discharge from the postoperative care

    Time frame: 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.

  5. Time to rescue analgesia

    Time frame: Postoperatively until discharge, an average of two days

    The time to rescue analgesia (in minutes) will be assessed.

  6. Patient satisfaction

    Time frame: 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).

  7. Length of hospital stay

    Time frame: Postoperatively until discharge, an average of two days

    Length of hospital stay (in days) will be reported.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 13, 2023
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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