Phase 2
N=50
Safety and Efficacy of CollaRx® Bupivacaine Implant in Men After Open Laparotomy Herniorrhaphy
Herniorrhaphy · Postoperative Pain · Inguinal Hernia
Bottom Line
View on ClinicalTrials.gov: NCT01220024 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Sum of Pain Intensity Defined as Area Under the Curve (AUC) of 100-mm VAS PI Scores. — 2810.4; 3484.5 score on a scale*hour
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bupivacaine Collagen Sponge (Drug); Placebo collagen Sponge (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Innocoll
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sum of Pain Intensity Defined as Area Under the Curve (AUC) of 100-mm VAS PI Scores. |
2810.4; 3484.5 | — |
| SECONDARY Sum of Pain Intensity (SPI) After Aggravated Movement (Cough) |
996.3; 1270.4; 1021.8; 1186.7; 2018.2; 2457.2 | — |
| SECONDARY Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest |
741.6; 856.6; 754.7; 677.2; 1496.4; 1533.8 | — |
| SECONDARY Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) |
31.4; 73.4; 32.6; 60.6; 31.2; 57.0 | — |
| SECONDARY Pain Intensity VAS Scores Over Time at Rest |
31.6; 73.4; 33.2; 60.6; 31.6; 57.0 | — |
| SECONDARY Mean Sum of Pain Intensity (SPI) Categorical Scores After Aggravated Movement |
40.6; 45.6; 83.3; 90.2; 118.9; 128.8 | — |
Summary
This study will assess pain intensity for the first 72 hrs after after aggravated movement (cough)following open laparotomy inguinal herniorrhaphy in patient who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.
Eligibility Criteria
Inclusion Criteria
- Man ≥ 18 years
- Body mass index (BMI) ≥ 19 and ≤ 40 kg/m2.
- Has a planned unilateral inguinal herniorrhaphy (open laparotomy, tension free technique) to be performed according to standard surgical technique under general anesthesia.
Exclusion Criteria
- Has a known hypersensitivity to amide local anesthetics, opioids, or bovine products.
- Scheduled for bilateral inguinal herniorrhaphy.
- Undergone a prior herniorrhaphy on the side scheduled for repair.
- Undergone major surgery within 3 mos of the scheduled herniorrhaphy.
- Has cardiac arrhythmias or atrioventricular (AV) conduction disorders.
- Concomitantly uses antiarrhythmics (eg, amiodarone, lidocaine), propranolol, or strong/moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers (eg, macrolide antibiotics and grapefruit juice).
- Used long acting analgesics within 24 hours of surgery. Short acting analgesics such as acetaminophen may be used on the day of surgery but are subject to preoperative restrictions for oral intake.
Data sourced from ClinicalTrials.gov (NCT01220024). 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.