Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acetaminophen for Chronic Pain in Hysterectomy

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: 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

Brief Summary:
The investigators hypothesized that 1 mg of acetaminophen 4 times per day for 3 days prevent chronic pain in hysterectomy patients.

Condition or disease Intervention/treatment Phase
Abdominal Hysterectomy (& Wertheim) Drug: Acetaminophen Drug: Isotonic Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Management of Chronic Pain With Acetaminophen Four Times a Day
Study Start Date : March 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Acetaminophen
Postoperative 72 hours acetaminophen 1 g iv 4 times a day for 72 hours iv
Drug: Acetaminophen
100 ml iv, 4 times a day for 72 hours
Other Name: Parol

Placebo Comparator: isotonic
1 g intravenous %0.9 NaCl four times Daily for 72 hours
Drug: Isotonic
100 ml iv, 4 times a day for 72 hours




Primary Outcome Measures :
  1. Acetaminophen prevents postoperative chronic pain in hysterectomy patients [ Time Frame: postoperative 3.months ]

Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02086747


Locations
Layout table for location information
Turkey
Mustafa Kemal University Medicine Faculty
Hatay, Turkey, 31030
Sponsors and Collaborators
Mustafa Kemal University
Investigators
Layout table for investigator information
Study Chair: Onur Koyuncu, Asist.Prof Mustafa Kemal University

Publications of Results:
Layout table for additonal information
Responsible Party: Onur Koyuncu, Asist.Prof, Mustafa Kemal University
ClinicalTrials.gov Identifier: NCT02086747     History of Changes
Other Study ID Numbers: 2013/33
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: March 13, 2015
Last Verified: March 2015
Keywords provided by Onur Koyuncu, Mustafa Kemal University:
Abdominal Hysterectomy, Acetaminophen, chronic pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Acetaminophen
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics