Postoperative Pain
Conditions
Keywords
Meniscectomy
Brief summary
The purpose of this study is to assess the benefit of OMS103HP for Injection (OMS103HP) compared with vehicle irrigation solution for prevention of pain and pain relief in subjects undergoing meniscectomy. The pain relief is assessed based on Visual Analog Scale (VAS) Pain Scores in the immediate 24-hour postoperative period and for seven days postoperatively.
Interventions
DRUGOMS103HP
Maximum 6 bags of OMS103HP irrigation solution
DRUGVehicle
Maximum of 6 bags of vehicle irrigation solution
Sponsors
Omeros Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subject has voluntarily signed informed consent form, including HIPAA Authorization. 2. Subject is ≥ 18 and ≤ 75 years of age. 3. Subject is in good general health with a traumatic or degenerative meniscal cartilage injury (full tear) that occurred at least 14 days prior to the day of arthroscopic surgery. 4. Subject is undergoing unilateral meniscectomy. 5. Subject's physical examination is within normal limits or examination is clinically nonsignificant as determined by the Investigator, and subject is in good general health. 6. Subject's laboratory evaluations are within normal limits or evaluations are clinically nonsignificant as determined by the Investigator. 7. Subject, if female and of childbearing potential (i.e., not surgically sterilized or post-menopausal greater than one year) agrees to use an effective method of birth control for the duration of her study involvement. 8. Subject is at minimal risk from anesthesia and is classified according to the American Society of Anesthesiologists Physical Status Classification as either PS-1 (a normal healthy patient) or PS-2 (a patient with mild systemic disease that results in no functional limitation). See Appendix VI. 9. Subject agrees to refrain from taking the excluded medications listed in
Exclusion criteria
through postoperative Day 7 (except for authorized analgesic medications) unless written permission has been granted by Omeros. 10. Subject is able to be proficient in the use of the ePRO device (documented at the site).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is the mean VAS at 24 hours postoperatively. | 24 hours |
Countries
United States
Outcome results
None listed