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

Lumbar; Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05764707
• Other study ID #: 2019P002750
• Status: Completed
• Phase: Phase 2
• Start date: January 10, 2020
• Est. completion date: February 3, 2023

Study information

• Verified date: February 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 3, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lumbar; Injury

Intervention

Drug:
• Acetaminophen
Patients will received 1000mg of intravenous acetaminophen within 30 minutes of skin closure.
• Placebo
Patients will received 1000mg of normal saline within 30 minutes of skin closure.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Intraoperative opioid consumption	Total cumulative morphine equivalents will be reported while the patient is in the operating room.	Intraoperatively
Secondary	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.
Secondary	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
Secondary	Time to rescue analgesia	The time to rescue analgesia (in minutes) will be assessed.	Postoperatively until discharge, an average of two days
Secondary	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.
Secondary	Length of hospital stay	Length of hospital stay (in days) will be reported.	Postoperatively until discharge, an average of two days