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

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Lumbar; Injury

Treatments: Drug: Placebo; Drug: Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT05764707

2019P002750

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Intravenous Acetaminophen

Experimental group

Description:

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

Treatment:

Drug: Acetaminophen

Intravenous Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo