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Assess the Feasibility and Efficacy of the CollaRx® Bupivacaine Implant Laparoscopic Inguinal or Umbilical Herniorrhaphy

NCT ID: NCT01224145

Last Updated: 2020-11-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-22

Study Completion Date

2011-06-20

Brief Summary

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This study will assess pain intensity for the first 72 hrs after aggravated movement (cough) following Laparoscopic Inguinal or Umbilical Herniorrhaphy.

Detailed Description

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Inguinal herniorrhaphy is a common surgery; approximately 2,800 per million people in the United States (US) undergo the procedure annually.Common surgical methods of herniorrhaphy include open and laparoscopic placement of synthetic mesh. Studies have shown that the use of synthetic mesh greatly reduces the risk of hernia recurrence regardless of the method used for its placement. Furthermore, utilizing the laparoscopic approach for umbilical hernia repair, specifically with the use of mesh, may also reduce the risk of infection.

Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile. Collagen is a protein that is found in all mammals. The CollaRx Bupivacaine implant is a thin flat sponge made out of collagen that comes from cow tendons and contains bupivacaine. When inserted into a surgical site, the collagen breaks down and bupivacaine is released at the site but very little is absorbed into the blood stream. The high levels of bupivacaine at the surgical site may result in less pain for several days after surgery.

This open-label study will assess pain intensity after surgery in patients who receive the CollaRx Bupivacaine implant as well as determine the feasibility of the use of the laparoscope for sponge placement in laparoscopic hernia repair.

Conditions

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Hernia Postoperative Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

laparoscope for bupivacaine sponge (200 mg bupivacaine hydrochloride) placement in laparoscopic hernia repair.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Drug: Bupivacaine Collagen Sponge

bupivacaine collagen sponges

Group Type EXPERIMENTAL

5x5cm bupivacaine collagen sponges

Intervention Type DRUG

Interventions

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5x5cm bupivacaine collagen sponges

Intervention Type DRUG

Other Intervention Names

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Bupivacaine collagen implant

Eligibility Criteria

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Inclusion Criteria

1. Man ≥18 years
2. 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.
3. Willing to use opioid rescue analgesia.

Exclusion Criteria

1. Has a known hypersensitivity to amide local anesthetics, opioids, or bovine products.
2. Scheduled for bilateral inguinal herniorrhaphy.
3. Undergone a prior herniorrhaphy at the location scheduled for repair.
4. Undergone major surgery within 3 months of the scheduled herniorrhaphy.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Premier Research Group plc

UNKNOWN

Sponsor Role collaborator

Innocoll

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Prior

Role: STUDY_DIRECTOR

Innocoll

Locations

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Research Concepts

Bellaire, Texas, United States

Site Status

Countries

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United States

References

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Hemsen L, Cusack SL, Minkowitz HS, Kuss ME. A feasibility study to investigate the use of a bupivacaine-collagen implant (XaraColl) for postoperative analgesia following laparoscopic surgery. J Pain Res. 2013;6:79-85. doi: 10.2147/JPR.S40158. Epub 2013 Feb 1.

Reference Type RESULT
PMID: 23390367 (View on PubMed)

Other Identifiers

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INN-CB-011

Identifier Type: -

Identifier Source: org_study_id