Acetaminophen for Chronic Pain in Hysterectomy
The Management of Chronic Pain With Acetaminophen Four Times a Day
1 other identifier
interventional
140
1 country
1
Brief Summary
The investigators hypothesized that 1 mg of acetaminophen 4 times per day for 3 days prevent chronic pain in hysterectomy patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 7, 2014
CompletedFirst Posted
Study publicly available on registry
March 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedMarch 13, 2015
March 1, 2015
1.4 years
February 7, 2014
March 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acetaminophen prevents postoperative chronic pain in hysterectomy patients
postoperative 3.months
Secondary Outcomes (1)
Postoperative pain
postoperative 0h, 1h, 4h, 8h, 12h, 16h, 20h, 24hours.
Other Outcomes (1)
Postoperative complications and ramsey sedation scores
Postoperative 24 hours
Study Arms (2)
Acetaminophen
ACTIVE COMPARATORPostoperative 72 hours acetaminophen 1 g iv 4 times a day for 72 hours iv
isotonic
PLACEBO COMPARATOR1 g intravenous %0.9 NaCl four times Daily for 72 hours
Interventions
Eligibility Criteria
You may qualify if:
- Patients 18-80 years old scheduled for hysterectomy
- Horizontal or vertical abdominal skin incision
- Ability to operate a patient-controlled analgesia (PCA) device
- Written informed consent.
You may not qualify if:
- ASA Physical Status I-II, emergency or urgent procedure
- Pre-existing chronic pain (at any site) requiring opioid analgesia
- History of significant Axis I psychiatric disease (major depressive disorder, bipolar disorder, schizophrenia, etc.)
- Significant hepatic (ALT or AST \> 2 times normal) or renal (serum creatinine \> 2 mg/dl) impairment; allergy to acetaminophen
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mustafa Kemal University Medicine Faculty
Hatay, 31030, Turkey (Türkiye)
Related Publications (1)
Sinatra RS, Jahr JS, Reynolds LW, Viscusi ER, Groudine SB, Payen-Champenois C. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery. Anesthesiology. 2005 Apr;102(4):822-31. doi: 10.1097/00000542-200504000-00019.
PMID: 15791113RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Onur Koyuncu, Asist.Prof
Mustafa Kemal University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Asist.Prof
Study Record Dates
First Submitted
February 7, 2014
First Posted
March 13, 2014
Study Start
March 1, 2013
Primary Completion
August 1, 2014
Study Completion
September 1, 2014
Last Updated
March 13, 2015
Record last verified: 2015-03