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Efficacy and Safety of the CollaRx Bupivacaine Implant Compared to the ON-Q Painbuster Following Abdominal Hysterectomy

Information source: Innocoll
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain, Postoperative

Intervention: Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant) (Device); ON-Q PainBuster Post-op Pain relief System (Device)

Phase: Phase 2

Status: Completed

Sponsored by: Innocoll

Official(s) and/or principal investigator(s):
David Prior, Study Director, Affiliation: Innocoll


The purpose of this study is to determine whether the CollaRx Bupivacaine Implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 96 hours after abdominal hysterectomy when compared to the ON-Q PainBuster Post-op Pain Relief System.

Clinical Details

Official title: A Phase II, Randomized, Single-dose, Unblinded Study to Compare the Efficacy and Safety of the CollaRx Bupivacaine Implant With the ON-Q PainBuster Post-op Pain Relief System in Women Following Abdominal Hysterectomy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Total amount of opioid rescue analgesia used

Secondary outcome:

Total amount of opioid rescue analgesia used

The total amount of opioid rescue analgesia used

Pain intensity rating on the Visual Analogue Scale (VAS)

Pain intensity on a 4-point scale

Pain relief on a 5-point scale

Patient global evaluation of study treatment on a 5-point scale

Changes in vital sign measurements

The incidence of treatment emergent Adverse Events

Patient questionnaire

Detailed description: Hysterectomy is the second most common surgery among women in the United States (US). Abdominal hysterectomy surgery may be performed to treat benign tumors, such as fibroids, heavy periods, painful periods and chronic pelvic pain. The most common route for performing hysterectomy is through an incision in the abdominal wall; however, about 20% are performed vaginally. Laparoscopic assisted vaginal hysterectomy is performed when warranted. Bupivacaine is a local anesthetic (pain medication) 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 cattle 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. The ON Q system consists of 1 elastometric pump with a fill volume of 270 mL containing 0. 25% bupivacaine; 1 soaker catheter measuring 12. 5 cm in size; and a fill port, tubing, clamp, filter and flow restrictor. The pump provides positive pressure and is portable. It may be attached to the patient's dressing or placed in a carrying pouch. The catheter is inserted directly into the surgical wound providing a continuous flow of bupivacaine into the wound. A capillary flow restricting orifice located at the end of the tubing controls the flow rate. This study will compare the total narcotic use in patients with the CollaRx Bupivacaine Implant with the total narcotic use in patients with the ON Q PainBuster Post op Pain Relief System after abdominal hysterectomy.


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Female.


Inclusion Criteria:

- Must be a woman who is ≥ 18 and ≤ 75 years of age.

- Has a body mass index (BMI) > 19 and < 40 kg/m2.

- Has planned an elective total abdominal hysterectomy for reasons other than

malignancies (such as uterine adenocarcinoma, cervical cancer or leiomyosarcoma) to be performed according to standard surgical technique using a standard incision and under general anesthesia with the following caveats:

- Laparoscopic procedures or supraumbilical or Maylard incisions will not be


- A nonlaparoscopic incision for benign nonhysterectomy gynecological procedures

(such as myomectomy or adnexal surgery) is acceptable if the surgical indication is not to treat pelvic pain.

- No concomitant vaginal procedures such as anterior and posterior colporrhaphy

(A&P repairs) are allowed. An abdominal urethropexy and an incidental appendectomy will be allowed.

- Has a risk classification of I, II or III according to the American Society of

Anesthesiologists (ASA).

- Is nonpregnant (negative pregnancy test at Screening and Day 0 before surgery) and


- Is free of other physical or mental conditions that, in the opinion of the

Investigator, may confound quantification of postoperative pain resulting from the abdominal hysterectomy.

- Has the ability to read, understand and comply with the study procedures and the use

of the pain scales; is deemed capable of operating a patient controlled analgesia (PCA) device; and is able to communicate meaningfully with the study staff.

- Must voluntarily sign and date an informed consent form (ICF), approved by an

Institutional Review Board (IRB), prior to the conduct of any study specific procedures.

- Must be able to fluently speak and understand English and be able to provide

meaningful written informed consent for the study. Exclusion Criteria:

- Has known hypersensitivity to amide local anesthetics, opioids, bovine products or to

inactive ingredients of the test article or reference product.

- Has cardiac arrhythmias or atrioventricular (AV) conduction disorders.

- Concomitantly uses other amide local anesthetics.

- Concomitantly uses antiarrhythmics (eg, amiodarone), propranolol or strong/moderate

cytochrome P450 (CYP) 3A4 inhibitors or inducers (eg, macrolide antibiotics and grapefruit juice).

- Has 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.

- Has used aspirin or aspirin containing products within 7 days of surgery. Aspirin at

a dose of ≤ 325 mg is allowed for cardiovascular prophylaxis if the patient has been on a stable dose regimen for ≥ 30 days prior to Screening.

- Has undergone major surgery within 3 months of the scheduled hysterectomy.

- Requires the use of Seprafilm® or other absorbable adhesion barriers for the

scheduled hysterectomy.

- Requires any additional surgical procedures either related or unrelated to the

abdominal hysterectomy during the same hospitalization (except for the specific allowed procedures noted in the Inclusion Criteria).

- Is required to receive neuraxial (spinal or epidural) opioid analgesics during the


- Has known or suspected history of alcohol or drug abuse or misuse within 3 years of

Screening or evidence of tolerance or physical dependency on opioid analgesics or sedative hypnotic medications.

- Has used opioids or tramadol on an extended daily basis (> 7 days) prior to surgery.

Patients who, in the Investigator's opinion, are developing opioid tolerance are to be excluded.

Locations and Contacts

Visions Clinical Research, Boynton Beach, Florida 33472, United States
Additional Information

Starting date: September 2008
Last updated: April 29, 2013

Page last updated: August 23, 2015

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