Phase 2
Completed N=27
Efficacy and Safety of the CollaRx Bupivacaine Implant Compared to the ON-Q Painbuster Following Abdominal Hysterectomy
Pain, Postoperative
Source: ClinicalTrials.gov NCT00749749 ↗
Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Total Amount of Opioid Rescue Analgesia Used — 46.85; 67.03 Morphine Milligrams
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 96 hours after abdominal hysterectomy when compared to the ON-Q PainBuster Post-op Pain Relief System.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Amount of Opioid Rescue Analgesia Used |
55.43; 74.85 | — |
| SECONDARY Total Amount of Opioid Rescue Analgesia Used |
55.43; 74.85 | — |
| SECONDARY The Total Amount of Opioid Rescue Analgesia Used |
67.87; 90.77 | — |
| SECONDARY Total Use of Opioid Rescue Analgesia (mg) Over 0 to 72 Hours |
61.98; 85.36 | — |
| SECONDARY Time to First Use of Opioid Rescue Analgesia |
0.78; 0.57 | — |
| SECONDARY VAS Pain Intensity Scores Over Time AT REST |
75.2; 74.5; 66.3; 66.5; 61.5; 68.6 | — |
| SECONDARY VAS (mm) Pain Intensity Scores Over Time (After Cough) |
84.4; 86.1; 76.5; 79.8; 73.8; 84.6 | — |
Eligibility Criteria
Inclusion Criteria
- Must be a woman who is ≥ 18 and ≤ 75 years of age.
- Has a body mass index (BMI) > 19 and 7 days) prior to surgery. Patients who, in the Investigator's opinion, are developing opioid tolerance are to be excluded.
Data sourced from ClinicalTrials.gov (NCT00749749). 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.