Clinical trial NCT01224145: Assess the Feasibility and Efficacy of the CollaRx® Bupivacaine Implant Laparoscopic Inguinal or Umbilical Herniorrhaphy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hernia
Postoperative Pain
Lead sponsor: Innocoll
Sponsor class: INDUSTRY
Collaborators: name: Premier Research Group plc
First posted: 2010-10-19
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: laparoscope for bupivacaine sponge (200 mg bupivacaine hydrochloride) placement in laparoscopic hernia repair.
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total Use of Opioid Analgesia - Morphine Equivalence (mg)
timeFrame: 0 to 24 hours after surgery
measure: Total Use of Opioid Rescue Analgesia - Morphine Equivalence (mg)
timeFrame: 25-48 hours
measure: Total Use of Opioid Rescue Analgesia - Morphine Equivalence (mg)
timeFrame: 49-72 Hours
measure: Total Use of Opioid Rescue Analgesia Morphine Equivalence (mg)
timeFrame: 0-48 hours)
measure: Total Use of Opioid Rescue Analgesia - Morphine Equivalence (mg)
timeFrame: 0-72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bellaire
country: United States
facility: Research Concepts
state: Texas
Study officials:
affiliation: Innocoll
name: David Prior
role: STUDY_DIRECTOR
References:
citation: 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.