Acetaminophen for Chronic Pain in Hysterectomy
Primary Purpose
Abdominal Hysterectomy (& Wertheim)
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Acetaminophen
Isotonic
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Hysterectomy (& Wertheim) focused on measuring Abdominal Hysterectomy, Acetaminophen, chronic pain
Eligibility 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
Sites / Locations
- Mustafa Kemal University Medicine Faculty
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Acetaminophen
isotonic
Arm Description
Postoperative 72 hours acetaminophen 1 g iv 4 times a day for 72 hours iv
1 g intravenous %0.9 NaCl four times Daily for 72 hours
Outcomes
Primary Outcome Measures
Acetaminophen prevents postoperative chronic pain in hysterectomy patients
Secondary Outcome Measures
Postoperative pain
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.
Full Information
NCT ID
NCT02086747
First Posted
February 7, 2014
Last Updated
March 12, 2015
Sponsor
Mustafa Kemal University
1. Study Identification
Unique Protocol Identification Number
NCT02086747
Brief Title
Acetaminophen for Chronic Pain in Hysterectomy
Official Title
The Management of Chronic Pain With Acetaminophen Four Times a Day
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mustafa Kemal University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Hysterectomy (& Wertheim)
Keywords
Abdominal Hysterectomy, Acetaminophen, chronic pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acetaminophen
Arm Type
Active Comparator
Arm Description
Postoperative 72 hours acetaminophen 1 g iv 4 times a day for 72 hours iv
Arm Title
isotonic
Arm Type
Placebo Comparator
Arm Description
1 g intravenous %0.9 NaCl four times Daily for 72 hours
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Parol
Intervention Description
100 ml iv, 4 times a day for 72 hours
Intervention Type
Drug
Intervention Name(s)
Isotonic
Intervention Description
100 ml iv, 4 times a day for 72 hours
Primary Outcome Measure Information:
Title
Acetaminophen prevents postoperative chronic pain in hysterectomy patients
Time Frame
postoperative 3.months
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
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.
Time Frame
postoperative 0h, 1h, 4h, 8h, 12h, 16h, 20h, 24hours.
Other Pre-specified Outcome Measures:
Title
Postoperative complications and ramsey sedation scores
Description
Postoperative complications and ramsey sedation scales are assessed in postoperative 0h, 1h, 4h, 8h, 12h, 16h, 20h, 24hours.
Time Frame
Postoperative 24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Onur Koyuncu, Asist.Prof
Organizational Affiliation
Mustafa Kemal University
Official's Role
Study Chair
Facility Information:
Facility Name
Mustafa Kemal University Medicine Faculty
City
Hatay
ZIP/Postal Code
31030
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
15791113
Citation
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.
Results Reference
result
Learn more about this trial
Acetaminophen for Chronic Pain in Hysterectomy
We'll reach out to this number within 24 hrs