Dataset Information

Safety and Efficacy of Bupivacaine HCl Collagen-Matrix Implant (INL-001) in Open Inguinal Hernia Repair: Results from Two Randomized Controlled Trials.

ABSTRACT:

Introduction

Surgical 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.

Methods

In 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.

Results

Patients 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.

Conclusion

These 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 registration

ClinicalTrials.gov identifiers, NCT02523599; NCT02525133.

Funding

Innocoll Pharmaceuticals. Plain language summary available for this article.

SUBMITTER: Velanovich V

PROVIDER: S-EPMC6318344 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundTypically, in-person follow-up in clinic is utilized after outpatient inguinal hernia repair. Studies have shown that phone follow-up may be successfully used for the detection of postoperative hernia recurrences. However, no studies have evaluated the detection rates of other postoperative complications, such as emergency department visits and readmissions, with the utilization of phone follow-up after inguinal hernia repair. The objective of our study was to investigate the safety of a phone follow-up care pathway following elective, outpatient inguinal hernia repair.MethodsIn this retrospective cohort study, adult patients who underwent elective, outpatient inguinal hernia repair between 2013 and 2019 at a large academic health system in the Midwest United States were identified from the electronic health record. Patients were categorized by type of postoperative follow-up: in-person or phone follow-up. Baseline demographics, operative, and postoperative data were compared between follow-up groups. Multivariable logistic regression was performed to investigate predictors of having any related emergency department (ED) visit/readmission/reoperation within 90 days.ResultsWe included 2009 patients who underwent elective inguinal hernia repair during the study period. 321 patients had in-person follow-up only, while 1,688 patients had phone follow-up. There was a higher rate of laparoscopic repair in the phone follow-up group (85.4% vs. 53.0% for in-person follow-up). There were no differences in rates of related 90-day ED visits, readmissions, and reoperations between the phone and in-person follow-up groups. On multivariable logistic regression, receipt of phone follow-up was not a predictor of having 90-day ED visits, readmissions, or reoperations (OR 1.30, 95% CI [0.83, 2.05]).ConclusionsPatients who underwent phone follow-up had similarly low rates of adverse outcomes to those with in-person follow-up. Phone follow-up protocols may be implemented as an alternative for patients and provide a means to decrease healthcare utilization following inguinal hernia repair.