NCT04574778

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2021

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

March 18, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

January 12, 2024

Status Verified

January 1, 2024

Enrollment Period

3.6 years

First QC Date

September 29, 2020

Last Update Submit

January 10, 2024

Conditions

Pain, PostoperativeSpine Surgery

Outcome Measures

Primary Outcomes (1)

  • Postoperative opioid usage

    Postoperative opioid usage over the first 24 hours will be reported in IV morphine equivalents

    1 day

Secondary Outcomes (3)

  • Quality of recovery

    1 day

  • Number of patients who report nausea or vomiting

    1 day

  • Mean pain score

    1 day

Study Arms (2)

Group 1: IV acetaminophen and PO placebo

ACTIVE COMPARATOR

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

Group 2: PO acetaminophen

ACTIVE COMPARATOR

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

Drug: Acetaminophen

Interventions

AcetaminophenDRUG

1000 mg of oral acetaminophen preoperatively administered

Group 1: IV acetaminophen and PO placeboGroup 2: PO acetaminophen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Related Publications (1)

  • Schwenk ES, Ferd P, Torjman MC, Li CJ, Charlton AR, Yan VZ, McCurdy MA, Kepler CK, Schroeder GD, Fleischman AN, Issa T. Intravenous versus oral acetaminophen for pain and quality of recovery after ambulatory spine surgery: a randomized controlled trial. Reg Anesth Pain Med. 2025 Jun 10;50(6):483-488. doi: 10.1136/rapm-2024-105386.

    PMID: 38499358DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Only those performing postoperative assessments and the participants will be blinded.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2020

First Posted

October 5, 2020

Study Start

March 18, 2021

Primary Completion

October 31, 2024

Study Completion

October 31, 2024

Last Updated

January 12, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)