Phase 2
N=10
Assess the Feasibility and Efficacy of the CollaRx® Bupivacaine Implant Laparoscopic Inguinal or Umbilical Herniorrhaphy
Hernia · Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT01224145 ↗Enrolled (actual)
10
Serious AEs
10.0%
Results posted
Nov 2020
Primary outcome: Primary: Total Use of Opioid Analgesia - Morphine Equivalence (mg) — 19.3 Morphine Equivalence (mg)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 5x5cm bupivacaine collagen sponges (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Innocoll
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Use of Opioid Analgesia - Morphine Equivalence (mg) |
19.3 | — |
| PRIMARY Total Use of Opioid Rescue Analgesia - Morphine Equivalence (mg) |
26.6 | — |
| PRIMARY Total Use of Opioid Rescue Analgesia - Morphine Equivalence (mg) |
26.6 | — |
| PRIMARY Total Use of Opioid Rescue Analgesia Morphine Equivalence (mg) |
24.6 | — |
| PRIMARY Total Use of Opioid Rescue Analgesia - Morphine Equivalence (mg) |
26.6 | — |
Summary
This study will assess pain intensity for the first 72 hrs after aggravated movement (cough) following Laparoscopic Inguinal or Umbilical Herniorrhaphy.
Eligibility Criteria
Inclusion Criteria
- Man ≥18 years
- Has a planned unilateral inguinal herniorrhaphy (laparoscopy, transabdominal preperitoneal [TAPP] approach or totally extraperitoneal [TEP] approach) or laparoscopic umbilical herniorrhaphy to be performed according to standard surgical technique under general anesthesia.
- Willing to use opioid rescue analgesia.
Exclusion Criteria
- Has a known hypersensitivity to amide local anesthetics, opioids, or bovine products.
- Scheduled for bilateral inguinal herniorrhaphy.
- Undergone a prior herniorrhaphy at the location scheduled for repair.
- Undergone major surgery within 3 months of the scheduled herniorrhaphy.
Data sourced from ClinicalTrials.gov (NCT01224145). 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.