Clinical trial NCT01220024: Safety and Efficacy of CollaRx® Bupivacaine Implant in Men After Open Laparotomy Herniorrhaphy
Official title: A Phase II, Randomized, Single Dose, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety Profile of the CollaRx® Bupivacaine Implant (200 mg Bupivacaine Hydrochloride) in Men After Open Laparotomy Herniorrhaphy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Herniorrhaphy
Postoperative Pain
Inguinal Hernia
Lead sponsor: Innocoll
Sponsor class: INDUSTRY
Collaborators: name: Premier Research Group plc
First posted: 2010-10-13
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess pain intensity for the first 72 hrs after after aggravated movement (cough)following open laparotomy inguinal herniorrhaphy in patient who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.

Detailed description: Inguinal herniorrhaphy is a common surgery; and common surgical methods used include laparoscopic and open placement of synthetic mesh. The use of synthetic mesh can greatly reduce the risk of hernia recurrence regardless of the method used for its placement. Managing postoperative pain and preventing morbidity after open mesh herniorrhaphy remain considerable medical challenges.

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 study will assess pain intensity after surgery in patients who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.

Eligibility criteria: Inclusion Criteria:

* Man ≥ 18 years
* Body mass index (BMI) ≥ 19 and ≤ 40 kg/m2.
* Has a planned unilateral inguinal herniorrhaphy (open laparotomy, tension free technique) to be performed according to standard surgical technique under general anesthesia.

Exclusion Criteria:

* Has a known hypersensitivity to amide local anesthetics, opioids, or bovine products.
* Scheduled for bilateral inguinal herniorrhaphy.
* Undergone a prior herniorrhaphy on the side scheduled for repair.
* Undergone major surgery within 3 mos of the scheduled herniorrhaphy.
* Has cardiac arrhythmias or atrioventricular (AV) conduction disorders.
* Concomitantly uses antiarrhythmics (eg, amiodarone, lidocaine), propranolol, or strong/moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers (eg, macrolide antibiotics and grapefruit juice).
* Used long acting analgesics within 24 hours of surgery. Short acting analgesics such as acetaminophen may be used on the day of surgery but are subject to preoperative restrictions for oral intake.

Primary outcomes:
measure: Sum of Pain Intensity Defined as Area Under the Curve (AUC) of 100-mm VAS PI Scores.
timeFrame: 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.
Secondary outcomes:
measure: Sum of Pain Intensity (SPI) After Aggravated Movement (Cough)
timeFrame: 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.
measure: Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest
timeFrame: 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.
measure: Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough)
timeFrame: 1,2,4,6,8,10,12,24,48 and 72 hours
measure: Pain Intensity VAS Scores Over Time at Rest
timeFrame: 1,2,4,6,8,10,12,24,48 and 72 hours
measure: Mean Sum of Pain Intensity (SPI) Categorical Scores After Aggravated Movement
timeFrame: 1,2,4,6,8,10,12,24,48 and 72 hours
Other outcomes:
Locations:
city: Bellaire
country: United States
state: Texas
Study officials:
affiliation: Innocoll
name: David Prior
role: STUDY_DIRECTOR
References:
citation: Cusack SL, Jaros M, Kuss M, Minkowitz HS, Winkle P, Hemsen L. Clinical evaluation of XaraColl((R)), a bupivacaine-collagen implant, for postoperative analgesia in two multicenter, randomized, double-blind, placebo-controlled pilot studies. J Pain Res. 2012;5:217-25. doi: 10.2147/JPR.S33453. Epub 2012 Jun 27.