Randomized Trial of Intraoperative IV Versus Preoperative Oral Acetaminophen During Ambulatory Lumbar Discectomy
Primary Purpose
Pain, Postoperative, Spine Surgery
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen
Sponsored by
About this trial
This is an interventional other trial for Pain, Postoperative
Eligibility 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).
Sites / Locations
- Rothman Orthopaedic InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1: IV acetaminophen and PO placebo
Group 2: PO acetaminophen
Arm Description
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
Group 2 will receive 1000 mg of PO acetaminophen in the holding area and will not receive an IV placebo.
Outcomes
Primary Outcome Measures
Postoperative opioid usage
Postoperative opioid usage over the first 24 hours will be reported in IV morphine equivalents
Secondary Outcome Measures
Quality of recovery
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)
Number of patients who report nausea or vomiting
this will be a count of the number of patients who report nausea or vomiting in recovery room
Mean pain score
(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
Full Information
NCT ID
NCT04574778
First Posted
September 29, 2020
Last Updated
August 15, 2023
Sponsor
Rothman Institute Orthopaedics
1. Study Identification
Unique Protocol Identification Number
NCT04574778
Brief Title
Randomized Trial of Intraoperative IV Versus Preoperative Oral Acetaminophen During Ambulatory Lumbar Discectomy
Official Title
Randomized Trial of IV Versus Oral Acetaminophen for Ambulatory Lumbar Discectomy or Single-level Decompression
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 18, 2021 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Spine Surgery
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Only those performing postoperative assessments and the study investigators will be blinded.
Allocation
Randomized
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1: IV acetaminophen and PO placebo
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group 2: PO acetaminophen
Arm Type
Active Comparator
Arm Description
Group 2 will receive 1000 mg of PO acetaminophen in the holding area and will not receive an IV placebo.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
1000 mg of oral acetaminophen preoperatively + IV placebo infusion intraoperatively 30 minutes prior to closure
Primary Outcome Measure Information:
Title
Postoperative opioid usage
Description
Postoperative opioid usage over the first 24 hours will be reported in IV morphine equivalents
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Quality of recovery
Description
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)
Time Frame
1 day
Title
Number of patients who report nausea or vomiting
Description
this will be a count of the number of patients who report nausea or vomiting in recovery room
Time Frame
1 day
Title
Mean pain score
Description
(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
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
revision 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).
Facility Information:
Facility Name
Rothman Orthopaedic Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thema Nicholson, MSc
Phone
267-339-3615
Email
thema.nicholson@rothmanortho.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Randomized Trial of Intraoperative IV Versus Preoperative Oral Acetaminophen During Ambulatory Lumbar Discectomy
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