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

This study has been completed.
Sponsor:
Collaborator:
Premier Research Group plc
Information provided by (Responsible Party):
Innocoll Technologies
ClinicalTrials.gov Identifier:
NCT00749749
First received: September 8, 2008
Last updated: April 29, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Pain, Postoperative
Device: Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant)
Device: ON-Q PainBuster Post-op Pain relief System
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Innocoll Technologies:

Primary Outcome Measures:
  • Total amount of opioid rescue analgesia used [ Time Frame: 0 to 24 hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total amount of opioid rescue analgesia used [ Time Frame: 0 to 48 hours postoperatively ] [ Designated as safety issue: No ]
  • The total amount of opioid rescue analgesia used [ Time Frame: 0 to 96 hours postoperatively ] [ Designated as safety issue: No ]
  • Pain intensity rating on the Visual Analogue Scale (VAS) [ Time Frame: At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48, 72 and 96 hours after Time 0 ] [ Designated as safety issue: No ]
  • Pain intensity on a 4-point scale [ Time Frame: At 30 minutes and 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48, 72 and 96 hours after Time 0 ] [ Designated as safety issue: No ]
  • Pain relief on a 5-point scale [ Time Frame: At 30 minutes and 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 48, 72 and 96 hours after Time 0 ] [ Designated as safety issue: No ]
  • Patient global evaluation of study treatment on a 5-point scale [ Time Frame: At 96 hours after Time 0 ] [ Designated as safety issue: No ]
  • Changes in vital sign measurements [ Time Frame: Through 96 hours after Time 0 ] [ Designated as safety issue: Yes ]
  • The incidence of treatment emergent Adverse Events [ Time Frame: Through 30 days after surgery ] [ Designated as safety issue: Yes ]
  • Patient questionnaire [ Time Frame: 96 hours postoperatively ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: September 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Three Bupivacaine sponges placed at different levels within the surgical cavity; one deep within the vault, one at the incision line in the peritoneum and one at the dermal incision line.
Device: Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant)
The bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride
Other Name: CollRx Bupivacaine Implant
Active Comparator: 2
Insertion of the ON-Q system catheter into the deep subcutaneous space overlying the fascia.
Device: ON-Q PainBuster Post-op Pain relief System
5 mL/hr per catheter of 0.25% bupivacaine (12.5 mg) for 72 hours(total dose 360 mL [900 mg])

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 allowed.
    • 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 nonlactating.
  • 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 surgery.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749749

Locations
United States, Florida
Visions Clinical Research
Boynton Beach, Florida, United States, 33472
Sponsors and Collaborators
Innocoll Technologies
Premier Research Group plc
Investigators
Study Director: David Prior Innocoll Technologies
  More Information

Publications:
Responsible Party: Innocoll Technologies
ClinicalTrials.gov Identifier: NCT00749749     History of Changes
Other Study ID Numbers: INN-CB-005
Study First Received: September 8, 2008
Last Updated: April 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Innocoll Technologies:
Abdominal Hysterectomy
Postoperative pain

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014