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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04574778
• Other study ID #: GSCHR19D.660
• Status: Recruiting
• Phase: Phase 3
• Start date: March 18, 2021
• Est. completion date: October 31, 2024

Study information

• Verified date: January 2024
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Pain, Postoperative
• Spine Surgery

Intervention

Drug:
• Acetaminophen
1000 mg of oral acetaminophen preoperatively administered

Locations

Country	Name	City	State
United States	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative opioid usage	Postoperative opioid usage over the first 24 hours will be reported in IV morphine equivalents	1 day
Secondary	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)	1 day
Secondary	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	1 day
Secondary	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	1 day