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Trial record 74 of 1201 for:    Acetaminophen

Acetaminophen for Chronic Pain in Hysterectomy

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ClinicalTrials.gov Identifier: NCT02086747
Recruitment Status : Completed
First Posted : March 13, 2014
Last Update Posted : March 13, 2015
Sponsor:
Information provided by (Responsible Party):
Onur Koyuncu, Mustafa Kemal University

Tracking Information
First Submitted Date  ICMJE February 7, 2014
First Posted Date  ICMJE March 13, 2014
Last Update Posted Date March 13, 2015
Study Start Date  ICMJE March 2013
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2014)
Acetaminophen prevents postoperative chronic pain in hysterectomy patients [ Time Frame: postoperative 3.months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02086747 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2014)
Postoperative pain [ Time Frame: postoperative 0h, 1h, 4h, 8h, 12h, 16h, 20h, 24hours. ]
After hysterectomy operations, postoperative pain is really high. Assesment and intervention to pain in postoperative period is important. We use narcotics in PCA and diclofenac in both groups also acetaminophen 1 g 4 times per day for 72 hours in one group.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE
 (submitted: March 12, 2014)
Postoperative complications and ramsey sedation scores [ Time Frame: Postoperative 24 hours ]
Postoperative complications and ramsey sedation scales are assessed in postoperative 0h, 1h, 4h, 8h, 12h, 16h, 20h, 24hours.
Original Other Outcome Measures  ICMJE Same as current
 
Descriptive Information
Brief Title  ICMJE Acetaminophen for Chronic Pain in Hysterectomy
Official Title  ICMJE The Management of Chronic Pain With Acetaminophen Four Times a Day
Brief Summary The investigators hypothesized that 1 mg of acetaminophen 4 times per day for 3 days prevent chronic pain in hysterectomy patients.
Detailed Description

The most appropriate expression of the pain is "an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage" (IASP,2008) (1). When pain lasts longer than 3 months or beyond the time when an acute injury would be expected to have healed, the patient's presentation becomes more complex, often, not surprisingly, with more psychological features. These include complaints of poor or non-refreshing sleep, tiredness, depression and poor concentration. Pain at this stage is often said to be "chronic" (2). Chronic pain is not only a common problem but also a significant and increasing public health burden in virtually all developed countries (3). Hysterectomy is one of the most common surgical procedures in women. Recent studies have recognized that there is a 20-40% incidence of chronic post-surgical pain after hysterectomy surgery (4)(5)(6). Effective pain management is an important component of postsurgical care. Many patients, however, continue to experience inadequate pain relief (7) Despite all analgesic strategies, in the postoperative periods 80% of patients still suffer from moderate to severe pain (8).

The ideal analgesic has some properties like rapid and effective pain relief, minimal adverse effects, and minimal impact on major organ systems or no interaction with other pharmacologic agents. Opioids are still good choice for postoperative pain but has dose dependent adverse effects and negative postoperative outcomes (9)(10). Nonopioid analgesics are commonly used alone or as adjuncts to opioid-based analgesia to treat moderate to severe pain. Perioperative administration of acetaminophen with nonsteroidal antiinflammatory drugs (NSAIDs) has been advocated to provide "multimodal" or "balanced" analgesia that decreases opioid dose requirements and may reduce associated adverse events while reducing postsurgical pain intensity ( 9)(11). Acetaminophen is superior to the other analgesics because of safety and analgesic profile. At the same time it has less contraindications and drug interactions with the others. Acetaminophen act by selectively inhibiting the release of prostaglandins within the central nervous system as well as having some peripheral analgesic effect (12). Rarely overdose use can induce hepatoxicity (13).

While providing fast and significant pain relief as well as a significant morphine-sparing effect,(14) (15). it is not associated with the increased incidence of nausea, vomiting, and respiratory depression observed with opioids or the deleterious gastrointestinal, hematologic, and renal effects associated with NSAIDs and cyclooxygenase (COX)-2 inhibitors (16).

Several international guidelines (EULAR, ACR) and influential reviews recommend the use of paracetamol as the first-line analgesic of choice for the management of chronic pain, as it provides cost-effective analgesia without the risks associated with NSAID use, particularly in the elderly. Based on currently available data, the use of alternative analgesics, such as tramadol and opioids, either alone or in combination with paracetamol, is warranted in those patients whose pain does not respond to nonnarcotic analgesics. While these recommendations are based on a vast amount of clinical data, they do not account for individual patient responses (17).

Paracetamol is rapidly absorbed from immediaterelease formulations, with maximum concentrations in plasma typically occurring between 0.25 and 2.0 hours, and an onset of action within about 30 minutes (18). Because the terminal elimination phase half-life of paracetamol in plasma is short, in the region of 1.9-2.5 hours after a therapeutic dose,(19) the recommended time between doses is 4-6 hours, resulting in a 4-times daily dosing schedule.

The investigators hypothesised that postoperative treatment with paracetamol with repeated doses of 1 g in comparison of placebo in hysterectomy patients with moderate or severe pain would decrease analgesics consumption perioperatively and the incidence of chronic pain associated with abdominal hysterectomy.

Study Type  ICMJE Interventional
Study Phase Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Abdominal Hysterectomy (& Wertheim)
Intervention  ICMJE
  • Drug: Acetaminophen
    100 ml iv, 4 times a day for 72 hours
    Other Name: Parol
  • Drug: Isotonic
    100 ml iv, 4 times a day for 72 hours
Study Arms
  • Active Comparator: Acetaminophen
    Postoperative 72 hours acetaminophen 1 g iv 4 times a day for 72 hours iv
    Intervention: Drug: Acetaminophen
  • Placebo Comparator: isotonic
    1 g intravenous %0.9 NaCl four times Daily for 72 hours
    Intervention: Drug: Isotonic
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2014)
140
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date September 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02086747
Other Study ID Numbers  ICMJE 2013/33
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Onur Koyuncu, Mustafa Kemal University
Study Sponsor  ICMJE Mustafa Kemal University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Onur Koyuncu, Asist.Prof Mustafa Kemal University
PRS Account Mustafa Kemal University
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP