ArticleAdvances in therapy2019
Safety and Efficacy of Bupivacaine HCl Collagen-Matrix Implant (INL-001) in Open Inguinal Hernia Repair: Results from Two Randomized Controlled Trials.
Article in Advances in therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 10 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of the XaraColl® Bupivacaine Implant (300 mg Bupivacaine Hydrochloride) After Open Laparotomy Hernioplasty
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of the XaraColl® Bupivacaine Implant (300 mg Bupivacaine Hydrochloride) After Open Laparotomy Hernioplasty
Who cites it
10 citing papers in PubMed.
- A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a bupivacaine hydrochloride implant in patients undergoing abdominoplasty.Regional anesthesia and pain medicine · 2023Trial
- Brush-like Polymer Surface on Silk Fibroin Films for Controlled Release of Local Anesthetics.ACS applied materials & interfaces · 2025Article
- Advances in the use of local anesthetic extended-release systems in pain management.Drug delivery · 2024Review
- Development of long-acting local anesthetics: a long way from basic research to clinical application.Journal of anesthesia · 2024Article
- Article
- Peripheral Regional Anesthesia Using Local Anesthetics: Old Wine in New Bottles?Journal of clinical medicine · 2023Review
- Biomaterials and Regenerative Medicine in Pain Management.Current pain and headache reports · 2022Review
- Novel Local Anesthetics in Clinical Practice: Pharmacologic Considerations and Potential Roles for the Future.Anesthesiology and pain medicine · 2022Review
- Updates on Wound Infiltration Use for Postoperative Pain Management: A Narrative Review.Journal of clinical medicine · 2021Review
- Degradable polymeric vehicles for postoperative pain management.Nature communications · 2021Review
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionSurgical site infiltration with bupivacaine results in short-lived analgesia. The MATRIX-1 and MATRIX-2 studies examined the efficacy and safety of the bioresorbable bupivacaine HCl collagen-matrix implant (INL-001) for postsurgical pain after open inguinal hernia repair. INL-001, designed to provide early and extended delivery of bupivacaine, provides prolonged duration of perioperative analgesia.
methodsIn two phase 3 double-blind studies [MATRIX-1 (ClinicalTrials.gov identifier, NCT02523599) and MATRIX-2 (ClinicalTrials.gov identifier, NCT02525133)], patients undergoing open tension-free mesh inguinal hernia repair were randomized to receive 300-mg bupivacaine (three INL-001 100-mg bupivacaine HCl collagen-matrix implants) (MATRIX-1 n = 204; MATRIX-2 n = 213) or three placebo collagen-matrix implants (MATRIX-1 n = 101; MATRIX-2 n = 106) during surgery. Postsurgical medication included scheduled acetaminophen and as-needed opioids.
resultsPatients who received INL-001 in both studies reported statistically significantly lower pain intensity (P ≤ 0.004; primary end point) and opioid analgesic use (P < 0.0001) through 24-h post-surgery versus those who received a placebo collagen-matrix. Patients who received INL-001 reported lower pain intensity through 72 h (P = 0.0441) for the two pooled studies. In both studies, more of the patients (28-42%) who received INL-001 used no opioid medication 0-24, 0-48, and 0-72 h post-surgery versus those who received a placebo collagen-matrix (12-22%). Among patients who needed opioid medication, patients receiving INL-001 used fewer opioids than those who received a placebo collagen-matrix through 24 h in both studies (P < 0.0001) and through 48 h in MATRIX-2 (P = 0.0003). Most adverse events were mild or moderate, without evidence of bupivacaine toxicity or deleterious effects on wound healing.
conclusionThese findings indicate that INL-001 results in post-inguinal hernia repair analgesia that is temporally aligned with the period of maximal postsurgical pain and may reduce the need for opioids while offering a favorable safety profile.
trial registrationClinicalTrials.gov identifiers, NCT02523599; NCT02525133.
fundingInnocoll Pharmaceuticals. Plain language summary available for this article.
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Registered trials
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