A Study of MK0663/Etoricoxib for Post-Abdominal Hysterectomy Surgery Pain (0663-097)(COMPLETED)
- Conditions
- -R52R52
- Registration Number
- PER-149-08
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 9
• The patient is female and> 18 years of age on the day of signing the informed consent
• The patient has been scheduled to undergo an open total abdominal hysterectomy using a transverse or Pfannestiel incision with general anesthesia.
• A patient with reproductive potential must demonstrate a level of p-HCG in urine consistent with a state of non-pregnancy at Visit 2 before randomization.
• Except for the need for gynecological surgery, it will be determined that the patient is otherwise in good health based on medical history, physical examination, and routine laboratory tests (see Appendices 6.1 and 6.2). Patients with chronic health conditions can participate as long as these conditions are stable.
• The patient understands the study procedures, available alternative treatments, and the risks involved with the study, and agrees to participate by providing written informed consent. The patient is able to read, understand and fill out questionnaires and diaries.
• The patient can sit from a supine position, stand up from a sitting position and walk (10 meters / 30 feet) without preoperative assistance.
• The patient is willing to restrict alcohol intake to <2 drinks or the equivalent per day during the time of the study and the follow-up period. A drink is defined as 2 ounces of high concentration alcohol, 5 ounces of wine or 12 ounces of beer.
• The patient has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that may confuse the results of the study, which in the opinion of the researcher contraindicates the use of etoricoxib or interferes with the patient´s participation for the entire duration. of the study, so that the participation of the patient / participant is not the most convenient (see Appendices 6.1 and 6.2). The following values will be considered exclusive: Hgb <8.5 g / dL, WBC <3500 / | uL, platelets <100,000 / pL, AST> 1.5 x ULN, ALT> 1.5 x ULN. Patients with these laboratory values will be excluded during Visit 1.
• The patient is legally incompetent (eg, a minor or mentally incapacitated), or has a history of a significant psychiatric disorder or has active psychosis, or significant emotional problems at the time of the study that in the opinion of the investigator are sufficient to interfere with driving of the study. Patients expected to be physically or mentally unable to operate a patient-controlled analgesia device (PCA) in the opinion of the investigator should be excluded.
• The patient is allergic or intolerant to, or has a significant clinical or laboratory adverse event associated with etoricoxib or other COX-2 inhibitors (ie celecoxib) / NSAIDs, or acetaminophen (paracetamol), or has hypersensitivity (i.e. , bronchoconstriction in relation to nasal polyps) to aspirin or other NSAIDs.
• The patient is allergic or intolerant to morphine, hydromorphone, oxycodone or other opioids.
• The patient is considered morbidly obese, since she has a BMI> 40 kg / m2
• The patient has a recent history (within 5 years) of abuse or dependence on chronic analgesics, opiates or tranquilizers, or is, at the time of signing the informed consent, consumer of recreational or illicit drugs or has had a recent history (within the last 5 years) of drug or alcohol abuse or dependence.
• The patient is currently participating or has participated in a study with a research compound or device within 4 weeks after signing the informed consent.
• The patient is undergoing surgery to treat chronic pelvic inflammatory disease (PID).
• The patient has a history of neoplastic disease or malignancy <5 years before signing the informed consent, except for cancer to the skin of basal cells or squamous cells or cervical cancer in situ properly treated, where both the investigator and the attending physician, the appropriate follow-up has not revealed evidence of recurrence from the moment of treatment until the time of selection. Patients with a history of leukemia, lymphoma, malignant melanoma and myeloproliferative disease are not eligible for the study, regardless of the time elapsed since treatment, and in such cases, no exceptions will apply. Patients who undergo surgery for advanced gynecological cancers are excluded from participation,
• The patient is using or planning to use any other treatment that may modulate pain perception (ie, physical techniques, surgery, psychological support) during the test.
• The patient has a known history of intra-abdominal adhesions.
• The patient has been scheduled to receive epidural or spinal anesthesia.
• The patient has ischemic heart disease, cerebrovascular disease or established peripheral vascular disease. In countries where the use of COX-II inhibitors has not been contraindicated in patients with these co
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Pain intensity at rest was measured on a 0- to 10-point scale: 0=no pain, to 10=pain as bad as you can imagine.<br><br>Measure:Average Pain Intensity at Rest Over Days 1 to 3<br>Timepoints:3 Days<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Elicited pain upon sitting was measured on a 0- to 10-point scale: 0=no pain, to 10=pain as bad as you can imagine.<br><br>Measure:Average Total Daily Dose of Morphine Over Days 1 to 3<br>Timepoints:3 days<br>;<br>Outcome name:Elicited pain upon sitting was measured on a 0- to 10-point scale: 0=no pain, to 10=pain as bad as you can imagine.<br>Measure:Average Elicited Pain Upon Sitting Over Days 1 to 3<br>Timepoints:3 days<br>