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Oral vs Intravenous Acetominophen for Postoperative Pain in Minimally Invasive Gynecologic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03391284
Recruitment Status : Unknown
Verified December 2017 by Bruce Kahn, Scripps Health.
Recruitment status was:  Enrolling by invitation
First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Bruce Kahn, Scripps Health

Brief Summary:

Hypothesis: Postoperative pain will be equivalent in patients receiving preemptive oral acetaminophen as compared to patients receiving preemptive intravenous acetaminophen following minimally invasive benign gynecologic surgery.

Primary outcome:

• Difference in postoperative pain comparing preemptive use of PO versus IV acetaminophen

o Mean Visual analog Scale (VAS) scores will be compared between the intervention group (PO acetaminophen) and the control group (IV acetaminophen).

Secondary outcomes:

  • Difference in postoperative analgesic use between groups

    o Narcotics, NSAIDs

  • Difference in postoperative N/V between groups

    o Patient rated measure - none, mild, moderate, severe

  • Cost comparison between drugs

Condition or disease Intervention/treatment Phase
Post-operative Pain Drug: acetominophen Drug: Acetaminophen Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Preemptive Oral vs Intravenous Acetominophen for Postoperative Pain in Minimally Invasive Gynecologic Surgery: A Randomized Control Trial
Study Start Date : February 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oral
1000 mg acetominophen oral
Drug: acetominophen
INTRAVENOUS
Other Name: Ofirmev

Drug: Acetaminophen
ORAL
Other Name: Tylenol

Active Comparator: Intravenous
1000 mg acetominophen intravenous
Drug: acetominophen
INTRAVENOUS
Other Name: Ofirmev

Drug: Acetaminophen
ORAL
Other Name: Tylenol




Primary Outcome Measures :
  1. Pain - VAS [ Time Frame: 2 hours ]

Secondary Outcome Measures :
  1. Pain - VAS [ Time Frame: 4 hours ]
  2. Pain - VAS [ Time Frame: 24 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 18 years of age or older scheduled to undergo robotic-assisted laparoscopic hysterectomy for benign conditions.

Exclusion Criteria:

  • Known or suspected malignancy,
  • Active liver/renal disease,
  • Chronic alcohol use/alcoholism,
  • Allergy to acetaminophen,
  • Conversion to laparotomy,
  • hx gastroparesis,
  • Poorly controlled insulin dependent diabetes or gastric bypass surgery,
  • Regular/recent (past 6 months) narcotic use,
  • Inability to swallow pills.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391284


Locations
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United States, California
Scripps Clinic
San Diego, California, United States, 92130
Scripps Clininc Dept of Ob/Gyn
San Diego, California, United States, 92130
Sponsors and Collaborators
Scripps Health
Investigators
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Principal Investigator: Bruce Kahn, MD Scripps

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bruce Kahn, PI, Scripps Health
ClinicalTrials.gov Identifier: NCT03391284    
Other Study ID Numbers: SCRIPPS-WHR-ACET-01
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: December 2017
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics