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.

Study Overview

• Status: Completed
• Conditions: Lumbar; Injury
• Intervention / Treatment: Drug: Acetaminophen; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02214
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intravenous Acetaminophen; Intravenous acetaminophen (1000mg) will be administered within 30 minutes of skin closure.	Drug: Acetaminophen; Patients will received 1000mg of intravenous acetaminophen within 30 minutes of skin closure.; Other Names: Tylenol
Placebo Comparator: Intravenous Placebo; Intravenous normal saline will be administered within 30 minutes of skin closure.	Drug: Placebo; Patients will received 1000mg of normal saline within 30 minutes of skin closure.; Other Names: Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Worst pain score in the post-anesthesia care unit	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.	Time of postoperative care unit discharge readiness, approximately 3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain scores	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.	Postoperatively until 72 hours or discharge, approximately three days
Intraoperative opioid consumption	Total cumulative morphine equivalents will be reported while the patient is in the operating room.	Intraoperatively
Postoperative opioid consumption in the post anesthesia care unit	Total cumulative morphine equivalents will be reported while the patient is in the post anesthesia care unit.	Postoperatively until time of PACU discharge, approximately 3 hours.
Postoperative opioid consumption after discharge from the postoperative care	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 of discharge from the postoperative care unit until discharge from the hospital, an average of two days
Time to rescue analgesia	The time to rescue analgesia (in minutes) will be assessed.	Postoperatively until discharge, an average of two days
Patient satisfaction	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).	Time of postoperative care unit discharge readiness, approximately 3 hours.
Length of hospital stay	Length of hospital stay (in days) will be reported.	Postoperatively until discharge, an average of two days

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2020
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): February 3, 2023

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: March 7, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 2019P002750

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No