NCT05764707

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2023

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

3.1 years

First QC Date

February 22, 2023

Last Update Submit

February 9, 2024

Conditions

Lumbar; Injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Postoperative pain scores

    Postoperatively until 72 hours or discharge, approximately three days

  • Intraoperative opioid consumption

    Intraoperatively

  • Postoperative opioid consumption in the post anesthesia care unit

    Postoperatively until time of PACU discharge, approximately 3 hours.

  • 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

  • Time to rescue analgesia

    Postoperatively until discharge, an average of two days

  • +2 more secondary outcomes

Study Arms (2)

Intravenous Acetaminophen

EXPERIMENTAL

Intravenous acetaminophen (1000mg) will be administered within 30 minutes of skin closure.

Drug: Acetaminophen

Intravenous Placebo

PLACEBO COMPARATOR

Intravenous normal saline will be administered within 30 minutes of skin closure.

Drug: Placebo

Interventions

AcetaminophenDRUG

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

Also known as: Tylenol
Intravenous Acetaminophen
PlaceboDRUG

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

Also known as: Normal Saline
Intravenous Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing 1-2 levels primary spine surgery ≥18 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

AcetaminophenSaline Solution

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anaesthesia

Study Record Dates

First Submitted

February 22, 2023

First Posted

March 13, 2023

Study Start

January 10, 2020

Primary Completion

January 31, 2023

Study Completion

February 3, 2023

Last Updated

February 12, 2024

Record last verified: 2024-02

Locations

US(1)