Phase 2
Completed N=54
Efficacy and Safety of a Collagen Bupivacaine Implant in Women Following Abdominal Hysterectomy
Source: ClinicalTrials.gov NCT00624910 ↗Enrolled (actual)
54
Serious AEs
5.6%
Results posted
Jan 2021
Primary outcomePrimary: Total Use of Opioid Rescue Analgesia — 53.65; 66.56; 53.73 mg morphine equivalents
Summary
The purpose of this study is to determine whether the CollaRx Bupivacaine implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after abdominal hysterectomy surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Use of Opioid Rescue Analgesia |
78.13; 88.60; 73.28 | — |
| SECONDARY Total Use of Opioid Rescue Analgesia |
78.13; 88.60; 73.28 | — |
| SECONDARY Pain Intensity Rating on a Visual Analog Scale (at Rest) |
58.5; 63.0; 66.5; 60.1; 61.3; 61.3 | — |
| SECONDARY Time to First Use of Opioid Rescue Analgesia |
0.9; 0.9; 0.4 | — |
| SECONDARY Pain Intensity Rating on a Visual Analog Scale (After Cough) |
68.2; 73.8; 72.6; 68.2; 67.3; 73.8 | — |
| SECONDARY Pain Intensity Rating on a 4-point Likert Scale (at Rest) |
1.8; 2.0; 2.2; 2.0; 2.2; 2.2 | — |
| SECONDARY Pain Intensity Rating on a 4-point Likert Scale (After Cough) |
2.1; 2.2; 2.4; 2.2; 2.5; 2.4 | — |
Eligibility Criteria
Inclusion Criteria
- Have a body mass index (BMI) > 19 and 7 days prior to test article administration
- Has impaired liver function
- Has any clinically significant unstable condition that could compromise the patient's welfare
- Is at risk for infection or slow wound healing
- Has a chronic painful condition that might confound the assessment of pain associated with the sugery
- Has taken pain medication that could confound the analgesic responses the day of surgery
- Has been treated within 2 weeks of surgery with agents that could affect the analgesic response
- Has been treated with monoamine oxidase inhibitors (MAOIs) or MAOIs have been stopped fewer than 10 days prior to surgery
- Has been treated with corticosteroids or whose treatment with these has been stopped < 7 days prior surgery (inhaled corticosteroids are acceptable)
- Has participated in a clinical trial in the previous 30 days
- Has been hemodynamically unstable at any point in the previous 4 weeks or becomes hemodynamically unstable during surgery
- Required blood transfusion in the previous month, except as related to uterine bleeding caused by uterine fibroids.
- Has hemoglobin levels < 10 g/dL or < 8 g/dL for patients with an anemia secondary to heavy uterine bleeding caused by uterine fibroids.
- Has platelet count < 100,000/mm
- Unreliable or incapable of complying with the protocol
Data sourced from ClinicalTrials.gov (NCT00624910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.