疝氣修補手術後疼痛輔助治療

本試驗的主要目的為，評估pregabalin相較於安慰劑在治療選擇性腹股溝部修復術後24+/-4小時急性疼痛方面的效果

膠囊劑

Pregabalin

130

25mg/ 75mg/150mg

本試驗的主要目的為，評估pregabalin相較於安慰劑在治療選擇性腹股溝部修復術後24+/-4小時急性疼痛方面的效果

Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the
study:
1. Male subjects between the ages of 18 and 75 years old.
2. The subject has provided written informed consent that must be obtained prior to
admission to this study.
3. The subject will have elective open unilateral inguinal herniorrhaphy, using mesh
Lichtenstein under general anesthesia or Monitored Anesthesia Care and fentanyl or
sufentanil/propofol initiation and sevoflurane, isoflurane or desflurane as required for
maintenance + local anesthetic infiltration at the conclusion of surgery. Study
surgery should be anticipated to be in the morning (ie, preoperative dose 2 given at
latest noon).
4. Expected to be able to use and tolerate NSAIDs, tramadol, oxycodone, and
acetaminophen/paracetamol for postoperative pain control.
5. The subject will be available for a visit within -30 to -1 day of the day of surgery if
not admitted the night before for baseline assessment and to receive study medication
prior to the day before surgery.
6. The subject is expected and agrees to remain at the hospital (or intermediate care
facility) for a minimum of 3 hours following surgery.
7. The subject’s preoperative health is graded as ASA P1 to P2 (See Appendix 1).
8. The subject is in satisfactory health as determined by the investigator on the basis of
medical history, physical examination and laboratory results.
9. Evidence of a personally signed and dated informed consent document indicating that
the subject (or a legally acceptable representative) has been informed of all pertinent
aspects of the study.
10. Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.

Exclusion Criteria
The presence of any of the following will exclude a subject from study enrollment:
1. Subjects having additional procedures at the same time as the total inguinal
herniorrhaphy.
2. Subjects with non-elective or emergency surgery, or hernia with incarceration.
3. Subjects with hernia repair that is not a primary repair.
4. The planned use of nerve block or spinal/epidural/paravertebral anesthesia or surgery
is not planned with general anesthesia or Monitored Anesthesia Care.
5. Subjects with a contraindication to the anesthesia agents indicated per protocol and
general anesthesia.
6. Subjects who have been using any opioid medications for more than 2 weeks for pain
control within three months of the Screening Visit.
7. Subjects with any cognitive impairment that would, in the investigator’s opinion,
preclude study participation or compliance with protocol mandated procedures
including careful completion of subject diary and treatment compliance.
8. Subjects with mobility or pain-related illness that would limit assessment of sit, walk
measures.
9. Subjects with a history of known alcohol, analgesic, or narcotic abuse (according to
DSM-IV criteria) within 12 months prior to Screening.
10. Subjects with a history of clinically significant intolerance or hypersensitivity to
pregabalin, gabapentin, oxycodone, NSAIDs, Tramadol, or
acetaminophen/paracetamol, and/or any analgesic which has a cross sensitivity to the
medications used in this study.
11. Subjects that had active or suspected esophageal, gastric, pyloric channel, or duodenal
ulceration or bleeding within 60 days prior to surgery.
12. Use of prohibited medications as listed in the protocol in the absence of appropriate
washout phase or the likelihood of requiring treatment during the study period with
drugs not permitted by the study protocol (See Appendix 4).
13. Subjects with a history of upper GI track ulcer/bleeding, myocardial infarction,
unstable myocardial ischemia (angina), deep venous thrombosis or pulmonary
embolism within three months of surgery.
14. Subjects considered clinically significantly volume-depleted in the opinion of the
Investigator.
15. Subjects that had inflammatory bowel disease, chronic or acute renal or hepatic
disorder, or a significant coagulation defect.
16. Subjects with a history or recurrent presence of asthma or bronchospasm which
requires treatment with glucocorticoids.
17. Subjects with a history of uncontrolled chronic disease that, in the opinion of the
investigator, would contraindicate study participation or confound interpretation of
results. Examples include clinically significant chronic pain conditions such as
post-herpetic neuralgia, painful diabetic peripheral neuropathy, and fibromyalgia as
well as chronic neurological disorders such as stroke, Parkinson’s disease or Multiple
Sclerosis.
18. Subject’s preoperative health graded as ASA P3 or higher (See Appendix 1).
19. Subjects treated for cancer (ie, surgery, chemotherapy, radiation therapy, etc.) and/or
in remission for any cancer other than basal cell carcinoma or squamous cell
carcinoma within 2 years of screening.
20. Subjects who received pregabalin within 30 days prior to the Screening Visit, or are
scheduled to receive any investigational drug during the course of this study or within
30 days of screening.
21. Any clinically significant or unstable medical condition that, in the opinion of the
investigator, would compromise participation in the study such as:
a. Significant renal disease;
b. Significant hepatic disease;
c. Significant respiratory disorder;
d. Significant hematologic disorders;
e. Significant immunologic diseases;
f. Unstable cardiovascular disease (See Appendix 3);
g. Significant inflammatory or rheumatologic diseases;
h. Active hepatitis B or C, HIV infection, or other significant infectious condition
diagnosed within the past 3 months;
i. Symptomatic peripheral vascular disease;
j. Untreated endocrine disorders.
22. Subjects expected to require analgesics or other agents other than as specified in the
protocol from the end of surgery through the end of the treatment period, which could
confound the analgesic responses (a longer interval may be necessary if the
confounding drug is long-acting or a sustained-release formulation).
23. Specifically excluded are tricyclic and SNRI antidepressants, anticonvulsants,
neuroleptics, neuroleptic antiemetics, COX-2 inhibitors, narcotics and oral or
intravenous corticosteroids. Subjects receiving aspirin for antithrombotic prophylaxis
at doses ≤325 mg/day are permitted to continue this treatment. Subjects receiving
Selective Serotonin Reuptake Inhibitors (SSRIs) at stable doses from 30 days prior to
surgery through the duration of the study and who are stable (without suicidal
ideation and other significant symptoms targeted by the SSRI) will be allowed. See
Appendix 4 for Prohibited Medications and Appendix 5 for Allowed Medications
with restrictions.
24. Subjects taking any NSAID or any analgesic other than acetaminophen within 2 day
prior to Baseline Visit and prior to surgery or are unwilling to abstain from other
analgesics, except as specified in the protocol, during the study. (Subjects taking
≤325 mg per day of aspirin at a stable dose for at least 30 days before the first dose of
study medication will be allowed to continue their aspirin regimen for the duration of
the study).
25. Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study.