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OpenTrials
Completed

NCT Number: NCT01224145

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

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

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Key information

Conditions

Hernia Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Research Concepts

Bellaire, Texas, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

5x5cm bupivacaine collagen sponges

Drug

Other names: Bupivacaine collagen implant

Primary outcomes

  1. Total Use of Opioid Analgesia - Morphine Equivalence (mg)

    Time frame: 0 to 24 hours after surgery

    Dosages of 1 to 2 mg per dose were titrated to patient comfort according to institutional standards and at the investigator's discretion. Once patients could tolerate oral medication, they were offered oral morphine (15 mg tablets) as rescue analgesia if necessary. The dose for patients who weighed less than 75kg was 15mg every 3 to 4 hours as needed for pain control. The dose for patients who weighed 75kg or more was 1-2 tablets (15-30 mg) every 3-4 hours for pain control. Morphine was the preferred rescue medication.

  2. Total Use of Opioid Rescue Analgesia - Morphine Equivalence (mg)

    Time frame: 25-48 hours

    Dosages of 1 to 2 mg per dose were titrated to patient comfort according to institutional standards and at the investigator's discretion. Once patients could tolerate oral medication, they were offered oral morphine (15 mg tablets) as rescue analgesia if necessary. The dose for patients who weighed less than 75kg was 15mg every 3 to 4 hours as needed for pain control. The dose for patients who weighed 75kg or more was 1-2 tablets (15-30 mg) every 3-4 hours for pain control. Morphine was the preferred rescue medication.

  3. Total Use of Opioid Rescue Analgesia - Morphine Equivalence (mg)

    Time frame: 49-72 Hours

    Dosages of 1 to 2 mg per dose were titrated to patient comfort according to institutional standards and at the investigator's discretion. Once patients could tolerate oral medication, they were offered oral morphine (15 mg tablets) as rescue analgesia if necessary. The dose for patients who weighed less than 75kg was 15mg every 3 to 4 hours as needed for pain control. The dose for patients who weighed 75kg or more was 1-2 tablets (15-30 mg) every 3-4 hours for pain control. Morphine was the preferred rescue medication.

  4. Total Use of Opioid Rescue Analgesia Morphine Equivalence (mg)

    Time frame: 0-48 hours)

    Dosages of 1 to 2 mg per dose were titrated to patient comfort according to institutional standards and at the investigator's discretion. Once patients could tolerate oral medication, they were offered oral morphine (15 mg tablets) as rescue analgesia if necessary. The dose for patients who weighed less than 75kg was 15mg every 3 to 4 hours as needed for pain control. The dose for patients who weighed 75kg or more was 1-2 tablets (15-30 mg) every 3-4 hours for pain control. Morphine was the preferred rescue medication.

  5. Total Use of Opioid Rescue Analgesia - Morphine Equivalence (mg)

    Time frame: 0-72 hours

    Dosages of 1 to 2 mg per dose were titrated to patient comfort according to institutional standards and at the investigator's discretion. Once patients could tolerate oral medication, they were offered oral morphine (15 mg tablets) as rescue analgesia if necessary. The dose for patients who weighed less than 75kg was 15mg every 3 to 4 hours as needed for pain control. The dose for patients who weighed 75kg or more was 1-2 tablets (15-30 mg) every 3-4 hours for pain control. Morphine was the preferred rescue medication.

Sponsors and collaborators

Lead sponsor

Innocoll

Industry

Collaborators

  • Premier Research

Registry information

Official study title

A Phase II, Single-dose, Open-label Study to Investigate the Feasibility and Efficacy of the CollaRx® Bupivacaine Implant (200 mg Bupivacaine Hydrochloride) in Men After Laparoscopic Inguinal or Umbilical Herniorrhaphy

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 19, 2010
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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