Recruiting
Phase 3

IV Acetaminophen

Sponsor:

Rothman Institute Orthopaedics

Code:

NCT04574778

Conditions

Pain, Postoperative

Spine Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acetaminophen

Study Details

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.

Conditions

Pain, Postoperative

Spine Surgery

Study ID

NCT04574778

Start date

Mar 18, 2021

Status verified date

Jan, 2024

Completion date

Oct 31, 2024

Anticipated

Primary completion date

Oct 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

82 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Group 1: IV acetaminophen and PO 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

active comparator: Group 2: PO acetaminophen

Group 2 will receive 1000 mg of PO acetaminophen in the holding area and will not receive an IV placebo.

Interventions

Acetaminophen

1000 mg of oral acetaminophen preoperatively administered

Primary outcome measure

  • Postoperative opioid usage [ Time Frame: 1 day ]

Central Contacts and Locations

Locations

Rothman Orthopaedic Institute

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

More Information

Sponsor

Rothman Institute Orthopaedics

Last update posted

Jan 12, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Rothman Institute Orthopaedics on 2024-01-12.