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

NCT00749749 | Completed Phase 2 Results

• 1 other identifier: INN-CB-005
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative

Keywords

Abdominal Hysterectomy; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• Total Amount of Opioid Rescue Analgesia Used

  Higher value means worse outcome - Higher number reflects a need for more analgesia - For the first 24 hours after surgery, patients received IV morphine via a PCA pump as rescue analgesia. Patient demand for morphine was recorded. Measurement recorded in total Morphine Milligrams

  0 to 24 hours postoperatively

Secondary Outcomes (6)

• Total Amount of Opioid Rescue Analgesia Used

  0 to 48 hours postoperatively

• The Total Amount of Opioid Rescue Analgesia Used

  0 to 96 hours postoperatively

• Total Use of Opioid Rescue Analgesia (mg) Over 0 to 72 Hours

  0 to 72 Hours

• Time to First Use of Opioid Rescue Analgesia

  0 to 72 hours

• VAS Pain Intensity Scores Over Time AT REST

  Hour 1, 1.5, 2,3,6,9,12,18,24,36,48,72,96

Study Arms (2)

Bupivacaine collagen sponge

EXPERIMENTAL

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.

Drug: Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant)

ON-ON-Q PainBuster Post-op Pain relief SystemQ system

ACTIVE COMPARATOR

Insertion of the ON-Q system catheter into the deep subcutaneous space overlying the fascia.

Drug: ON-Q PainBuster Post-op Pain relief System

Interventions

Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant) DRUG

The bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride

Also known as: CollRx Bupivacaine Implant

Bupivacaine collagen sponge

ON-Q PainBuster Post-op Pain relief System DRUG

5 mL/hr per catheter of 0.25% bupivacaine (12.5 mg) for 72 hours(total dose 360 mL \[900 mg\])

ON-ON-Q PainBuster Post-op Pain relief SystemQ system

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Innocoll: lead
• Premier Research: collaborator

Study Sites (1)

Visions Clinical Research

Boynton Beach, Florida, 33472, United States

Location

Related Publications (1)

• Cusack SL, Minkowitz HS, Kuss M, Jaros M, Hemsen L. A randomized, multicenter, pilot study comparing the efficacy and safety of a bupivacaine-collagen implant (XaraColl((R))) with the ON-Q PainBuster((R)) Post-op Pain Relief System following open gynecological surgery. J Pain Res. 2012;5:453-61. doi: 10.2147/JPR.S37310. Epub 2012 Nov 2.

  PMID: 23152696 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2008
• First Posted: September 9, 2008
• Study Start: September 10, 2008
• Primary Completion: December 22, 2008
• Study Completion: December 22, 2008
• Last Updated: November 4, 2020
• Results First Posted: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)