NCT01852955

Brief Summary

Recent evidence demonstrates that perioperative pain continues to be poorly managed among ambulatory surgical patients. More importantly, few interventions that minimize postoperative pain have also shown to improve patient overall quality of post-surgical recovery. Ketorolac has been used to minimize perioperative pain despite the lack of evidence for its use when administered as a single dose preventive strategy.Ketorolac has also been associated with a higher incidence of perioperative hematomas and the need for surgical re-exploration after breast surgery. Systemic acetaminophen has become recently available in The United States. In contrast to ketorolac, systemic acetaminophen has not been reported to have adverse side effects on patients undergoing breast surgery. Although evidence suggests that a single dose perioperative acetaminophen reduces postoperative pain, it remains unknown if a single dose intravenous acetaminophen improves postoperative quality of recovery after ambulatory surgery. The main objective of the current investigation is to evaluate the effect of a single dose systemic acetaminophen on postoperative quality of recovery after ambulatory breast surgery. We also seek to determine if systemic acetaminophen would decrease postoperative pain and the time to hospital discharge in the same population. Significance: The current project evaluates a potential intervention to improve perioperative pain and recovery after ambulatory breast surgery. Postoperative pain in the ambulatory surgical patients has been shown consistently to be poorly managed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

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

May 9, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 14, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 14, 2016

Completed
Last Updated

March 14, 2016

Status Verified

February 1, 2016

Enrollment Period

1.1 years

First QC Date

May 9, 2013

Results QC Date

January 19, 2016

Last Update Submit

February 16, 2016

Conditions

Pain

Keywords

OutpatientSurgeryBreastPain

Outcome Measures

Primary Outcomes (1)

  • Quality of Recovery at 24 Hours(QoR-40 Instrument)

    Quality of recovery score 24 hours after the surgical procedure. Total score range of 40 (poor recovery) and a score of 200 (good recovery).

    24 hours after the surgical procedure

Secondary Outcomes (2)

  • Postoperative Opioid Consumption

    24 hour

  • Postoperative Pain in the Post Anesthesia Care Unit

    Time in the post anesthesia care unit after surgery (average of 5 hours)

Study Arms (2)

IV acetaminophen

ACTIVE COMPARATOR

Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.

Drug: IV acetaminophen

Placebo

PLACEBO COMPARATOR

Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen

Drug: Placebo

Interventions

IV acetaminophenDRUG

Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure

IV acetaminophen
PlaceboDRUG

Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatient lumpectomy
  • ASA I and II
  • Age between 18-70

You may not qualify if:

  • Pregnancy
  • History of liver disease
  • Unable to understand the informed consent
  • Chronic pain with use of opioid in the last week
  • Allergy to acetaminophen
  • Drop-out: surgeon or patient request

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (6)

  • American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.

    PMID: 22227789BACKGROUND

  • De Oliveira GS Jr, Fitzgerald P, Streicher LF, Marcus RJ, McCarthy RJ. Systemic lidocaine to improve postoperative quality of recovery after ambulatory laparoscopic surgery. Anesth Analg. 2012 Aug;115(2):262-7. doi: 10.1213/ANE.0b013e318257a380. Epub 2012 May 14.

    PMID: 22584558BACKGROUND

  • De Oliveira GS Jr, Ahmad S, Fitzgerald PC, Marcus RJ, Altman CS, Panjwani AS, McCarthy RJ. Dose ranging study on the effect of preoperative dexamethasone on postoperative quality of recovery and opioid consumption after ambulatory gynaecological surgery. Br J Anaesth. 2011 Sep;107(3):362-71. doi: 10.1093/bja/aer156. Epub 2011 Jun 13.

    PMID: 21669954BACKGROUND

  • De Oliveira GS Jr, Agarwal D, Benzon HT. Perioperative single dose ketorolac to prevent postoperative pain: a meta-analysis of randomized trials. Anesth Analg. 2012 Feb;114(2):424-33. doi: 10.1213/ANE.0b013e3182334d68. Epub 2011 Sep 29.

    PMID: 21965355BACKGROUND

  • Cawthorn TR, Phelan R, Davidson JS, Turner KE. Retrospective analysis of perioperative ketorolac and postoperative bleeding in reduction mammoplasty. Can J Anaesth. 2012 May;59(5):466-72. doi: 10.1007/s12630-012-9682-z. Epub 2012 Mar 21.

    PMID: 22434401BACKGROUND

  • McNicol ED, Tzortzopoulou A, Cepeda MS, Francia MB, Farhat T, Schumann R. Single-dose intravenous paracetamol or propacetamol for prevention or treatment of postoperative pain: a systematic review and meta-analysis. Br J Anaesth. 2011 Jun;106(6):764-75. doi: 10.1093/bja/aer107. Epub 2011 May 9.

    PMID: 21558067BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Gildasio De Oliveira, M.D.
Organization
Northwestern University
gjr@northwestern.edu
312-695-4858

Study Officials

  • Gildasio De Oliveira, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 9, 2013

First Posted

May 14, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 14, 2016

Results First Posted

March 14, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)