RECRUITING

Randomized Trial of Intraoperative IV Versus Preoperative Oral Acetaminophen During Ambulatory Lumbar Discectomy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Effective non-opioid analgesics are of particular interest in ambulatory surgery, as providers may be able to reduce pain while avoiding perioperative opioids that can delay same day discharge. The value of maintaining an efficient flow of patients from the perioperative area to discharge is an important metric for same day surgery centers, and an improvement in efficiency with IV acetaminophen could potentially offset the increased cost of the medication while providing a more pleasant surgical experience for patients. The goal of this study is to compare the efficacy of intraoperative IV administration vs. preoperative oral administration of acetaminophen on postoperative opioid utilization, patient-reported pain scores, opioid-related adverse effects, and time to recovery and discharge from the post-anesthesia care unit (PACU) after ambulatory lumbar discectomy.

Official Title

Randomized Trial of IV Versus Oral Acetaminophen for Ambulatory Lumbar Discectomy or Single-level Decompression

Quick Facts

Study Start:2021-03-18
Study Completion:2024-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04574778

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age greater than 18 years-old
  2. * Weight greater than 50 kg body weight
  3. * ASA physical status I-III
  4. * English-speaking
  1. * Weight less than 50 kg
  2. * Pregnancy or breast feeding
  3. * revision surgery
  4. * Contraindications to the administration of acetaminophen (e.g. allergy, liver failure, etc)
  5. * Chronic pain conditions unrelated to back pain
  6. * Opioid tolerance ( defined as taking greater than oxycodone 20 mg daily for a week during the past month).

Contacts and Locations

Study Locations (Sites)

Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
United States

Collaborators and Investigators

Sponsor: Rothman Institute Orthopaedics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-18
Study Completion Date2024-10-31

Study Record Updates

Study Start Date2021-03-18
Study Completion Date2024-10-31

Terms related to this study

Additional Relevant MeSH Terms

  • Pain, Postoperative
  • Spine Surgery