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

NCT01224145 | Completed Phase 2 Results

• 1 other identifier: INN-CB-011
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hernia; Postoperative Pain

Outcome Measures

Primary Outcomes (5)

• Total Use of Opioid Analgesia - Morphine Equivalence (mg)

  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.

  0 to 24 hours after surgery

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

  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.

  25-48 hours

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

  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.

  49-72 Hours

• Total Use of Opioid Rescue Analgesia Morphine Equivalence (mg)

  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.

  0-48 hours)

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

  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.

  0-72 hours

Study Arms (1)

Drug: Bupivacaine Collagen Sponge

EXPERIMENTAL

bupivacaine collagen sponges

Drug: 5x5cm bupivacaine collagen sponges

Interventions

5x5cm bupivacaine collagen sponges DRUG

Also known as: Bupivacaine collagen implant

Drug: Bupivacaine Collagen Sponge

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innocoll: lead
• Premier Research: collaborator

Study Sites (1)

Research Concepts

Bellaire, Texas, United States

Location

Related Publications (1)

• 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.

  PMID: 23390367 RESULT

MeSH Terms

Conditions

Hernia; Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Charlene A. Tucker, MS Executive Director, Medical Writing and Document Management
• Organization: Innocoll

ctucker@innocoll.com

484-406-5211

Study Officials

• David Prior

  Innocoll

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: laparoscope for bupivacaine sponge (200 mg bupivacaine hydrochloride) placement in laparoscopic hernia repair.

Study Record Dates

• First Submitted: October 18, 2010
• First Posted: October 19, 2010
• Study Start: March 22, 2011
• Primary Completion: June 20, 2011
• Study Completion: June 20, 2011
• Last Updated: November 4, 2020
• Results First Posted: November 4, 2020

Record last verified: 2020-10

Locations

US (1)