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

Sponsor

Rothman Institute Orthopaedics (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04574778

Collaborator

(none)

Enrollment

Location

Arms

7.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative Spine Surgery	Drug: Acetaminophen	Phase 3

Study Design

Study Type:

Interventional

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 :

Mar 18, 2021

Anticipated Primary Completion Date :

Oct 31, 2021

Anticipated Study Completion Date :

Oct 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Postoperative opioid usage [1 day]
Postoperative opioid usage over the first 24 hours will be reported in IV morphine equivalents

Secondary Outcome Measures

Quality of recovery [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)
Number of patients who report nausea or vomiting [1 day]
this will be a count of the number of patients who report nausea or vomiting in recovery room
Mean pain score [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rothman Institute Orthopaedics

ClinicalTrials.gov Identifier:

NCT04574778

Other Study ID Numbers:

GSCHR19D.660

First Posted:

Oct 5, 2020

Last Update Posted:

Mar 23, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Pain, Postoperative

Acetaminophen

Study Results

No Results Posted as of Mar 23, 2021