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Trial record 56 of 1877 for:    ACETAMINOPHEN

The Effectiveness of IV/PO Acetaminophen in the Perioperative Period in Reducing Opiate Use After Lumbar Spine Fusion

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ClinicalTrials.gov Identifier: NCT03104816
Recruitment Status : Terminated (Could not get an approval from Department Reviewer for the study continuation.)
First Posted : April 7, 2017
Results First Posted : October 8, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Eugenia Ayrian, University of Southern California

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Fusion of Spine, Lumbar Region
Interventions Drug: Acetaminophen IV Soln 10 MG/ML
Drug: Acetaminophen
Drug: Hydromorphone
Enrollment 28
Recruitment Details 28 patients were involved in study. 22 patients completed the study. Patients were recruited in the surgical clinic, preoperative clinic, preoperative surgical area.
Pre-assignment Details Patients were included in the study according to their inclusion and exclusion criteria. There were no patients were excluded from study in the period after signing the consent to assignment to groups.
Arm/Group Title Acetaminophen IV Soln 10 Milligram/Milliliter (MG/ML) (A) PO Acetaminophen (B) Hydromorphone (Control Arm) (C)
Hide Arm/Group Description

Patients in group A will receive 1 g of IV acetaminophen 15 minutes prior to wound incision, and every 4 to 6 hours postoperatively for a total of 4 grams in 24 hours.

Acetaminophen IV Soln MG/ML

Hydromorphone

Patients in group B will receive 1 g of PO acetaminophen prior to surgery, and 1 g of oral acetaminophen every 4 to 6 hours postoperatively for a total of 4 grams in 24 hours.

Acetaminophen

Hydromorphone

Patients in the control arm (Group C) will not receive acetaminophen for 24 hours.

Hydromorphone

Period Title: Overall Study
Started 11 11 6
Completed 9 9 4
Not Completed 2 2 2
Reason Not Completed
Lack of Efficacy             0             2             0
Protocol Violation             2             0             2
Arm/Group Title Acetaminophen IV Soln 10 MG/ML (A) PO Acetaminophen (B) Hydromorphone (Control Arm) (C) Total
Hide Arm/Group Description

Patients in group A will receive 1 g of IV acetaminophen 15 minutes prior to wound incision, and every 4 to 6 hours postoperatively for a total of 4 grams in 24 hours.

Acetaminophen IV Soln 10 MG/ML

Hydromorphone

Patients in group B will receive 1 g of PO acetaminophen prior to surgery, and 1 g of oral acetaminophen every 4 to 6 hours postoperatively for a total of 4 grams in 24 hours.

Acetaminophen

Hydromorphone

Patients in the control arm (Group C) will not receive acetaminophen for 24 hours.

Hydromorphone

Total of all reporting groups
Overall Number of Baseline Participants 9 9 4 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 4 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  33.3%
5
  55.6%
3
  75.0%
11
  50.0%
>=65 years
6
  66.7%
4
  44.4%
1
  25.0%
11
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 4 participants 22 participants
Female
5
  55.6%
9
 100.0%
1
  25.0%
15
  68.2%
Male
4
  44.4%
0
   0.0%
3
  75.0%
7
  31.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 4 participants 22 participants
Hispanic or Latino
1
  11.1%
2
  22.2%
0
   0.0%
3
  13.6%
Not Hispanic or Latino
8
  88.9%
7
  77.8%
4
 100.0%
19
  86.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 9 participants 4 participants 22 participants
9 9 4 22
Number of analyzed participants in each group  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 4 participants 22 participants
9
 100.0%
9
 100.0%
4
 100.0%
22
 100.0%
1.Primary Outcome
Title Postoperative Opioid Use
Hide Description Determine the impact of administering a supplemental non-opioid analgesic drug such as IV/oral acetaminophen on total opioid dose administered over the perioperative period.
Time Frame Within 24 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen IV Soln 10 MG/ML (A) PO Acetaminophen (B) Hydromorphone (Control Arm) (C)
Hide Arm/Group Description:
Hydromorphone and IV Acetaminophen are given to this group
Hydromorphone and PO acetaminophen are given to this group
Hydromorphone only is given to the patients in this group
Overall Number of Participants Analyzed 9 9 4
Mean (Standard Deviation)
Unit of Measure: mg
PACU dose 1.2  (0.4) 1.3  (0.3) 1.7  (0.5)
Ward dose 9.8  (2.9) 10.4  (3.1) 13  (5.5)
Time Frame Adverse events were collected within 24 hours.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acetaminophen IV Soln 10 MG/ML (A) PO Acetaminophen (B) Hydromorphone (Control Arm) (C)
Hide Arm/Group Description

Patients in group A will receive 1 g of IV acetaminophen 15 minutes prior to wound incision, and every 4 to 6 hours postoperatively for a total of 4 grams in 24 hours.

Acetaminophen IV Soln 10 MG/ML

Hydromorphone

No adverse events.

Patients in group B will receive 1 g of PO acetaminophen prior to surgery, and 1 g of oral acetaminophen every 4 to 6 hours postoperatively for a total of 4 grams in 24 hours.

Acetaminophen

Hydromorphone

No adverse events.

Patients in the control arm (Group C) will not receive acetaminophen for 24 hours.

Hydromorphone

No adverse events.

All-Cause Mortality
Acetaminophen IV Soln 10 MG/ML (A) PO Acetaminophen (B) Hydromorphone (Control Arm) (C)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%)   0/4 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Acetaminophen IV Soln 10 MG/ML (A) PO Acetaminophen (B) Hydromorphone (Control Arm) (C)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%)   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Acetaminophen IV Soln 10 MG/ML (A) PO Acetaminophen (B) Hydromorphone (Control Arm) (C)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%)   0/4 (0.00%) 
The trial was not completed and had very small amount of participants.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eugenia Ayrian
Organization: USCalifornia
Phone: 8186363161
EMail: eayrian@med.usc.edu
Layout table for additonal information
Responsible Party: Eugenia Ayrian, University of Southern California
ClinicalTrials.gov Identifier: NCT03104816     History of Changes
Other Study ID Numbers: HS-15-00615
First Submitted: March 29, 2017
First Posted: April 7, 2017
Results First Submitted: July 14, 2019
Results First Posted: October 8, 2019
Last Update Posted: October 8, 2019