Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04574778
Recruitment Status : Enrolling by invitation
First Posted : October 5, 2020
Last Update Posted : March 23, 2021
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Spine Surgery Drug: Acetaminophen Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: Only those performing postoperative assessments and the study investigators will be blinded.
Primary Purpose: Other
Official Title: Randomized Trial of IV Versus Oral Acetaminophen for Ambulatory Lumbar Discectomy or Single-level Decompression
Actual Study Start Date : March 18, 2021
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group 1: IV acetaminophen and oral placebo
Group 1 will receive 1000 mg of IV acetaminophen approximately 30 minutes prior to skin closure and will receive oral placebo in the holding area prior to surgery
Drug: Acetaminophen
1000 mg of oral acetaminophen preoperatively + IV placebo infusion intraoperatively 30 minutes prior to closure

Active Comparator: Group 2: oral acetaminophen
Group 2 will receive 1000 mg of PO acetaminophen in the holding area and will not receive an IV placebo.
Drug: Acetaminophen
1000 mg of oral acetaminophen preoperatively + IV placebo infusion intraoperatively 30 minutes prior to closure




Primary Outcome Measures :
  1. Postoperative opioid usage [ Time Frame: 1 day ]
    Postoperative opioid usage over the first 24 hours will be reported in IV morphine equivalents


Secondary Outcome Measures :
  1. Quality of recovery [ Time Frame: 1 day ]
    assessed using the Quality of Recovery 15 scale, with a range of 0-150 (0 is the worst score and 150 is the best possible recovery)

  2. Number of patients who report nausea or vomiting [ Time Frame: 1 day ]
    this will be a count of the number of patients who report nausea or vomiting in recovery room

  3. Mean pain score [ Time Frame: 1 day ]
    (0-10 numerical rating scale where 0=no pain and 10=worst pain imaginable) - this will be the mean pain rating upon entering pacu and at least 1 other time point in each study group



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age greater than 18 years-old
  • Weight greater than 50 kg body weight
  • ASA physical status I-III
  • English-speaking

Exclusion Criteria:

  • Weight less than 50 kg
  • Pregnancy or breast feeding
  • Prior lumbar surgery
  • Contraindications to the administration of acetaminophen (e.g. allergy, liver failure, etc)
  • Chronic pain conditions unrelated to back pain
  • Opioid tolerance ( defined as taking greater than oxycodone 20 mg daily for a week during the past month).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04574778


Locations
Layout table for location information
United States, Pennsylvania
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
Layout table for additonal information
Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04574778    
Other Study ID Numbers: GSCHR19D.660
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics