Pain, PostoperativePhase 2NCT00749749

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

A Phase 2 study testing Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant) and ON-Q PainBuster Post-op Pain relief System in people with Pain, Postoperative, run by Innocoll at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: Pain, Postoperative
What is being tested?: Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant) and ON-Q PainBuster Post-op Pain relief System
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteUnited States
Study dates: 10 Sep 2008to 22 Dec 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

Show all 12Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Visions Clinical Research
Boynton Beach, Florida, 33472

Other trials in United States

About this study

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

Read the 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.

Conditions: Pain, Postoperative
Being tested: Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant), ON-Q PainBuster Post-op Pain relief System
Keywords: Abdominal Hysterectomy, Postoperative pain
Medical subject headings: Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant)Drug
Also called CollRx Bupivacaine Implant
The bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride
ON-Q PainBuster Post-op Pain relief SystemDrug
5 mL/hr per catheter of 0.25% bupivacaine (12.5 mg) for 72 hours(total dose 360 mL [900 mg])

Study groups in NCT00749749
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: ON-Q PainBuster Post-op Pain relief System

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 0 to 24 hours postoperatively

Secondary outcomes (6)

Total Amount of Opioid Rescue Analgesia Used
Higher score means worse outcome - Higher number means more Analgesia was needed. For the first 24 hours after surgery, patients received IV morphine via a PCA pump as rescue analgesia. Patient demand for morphine was recorded. After 24 hours, patients were offered hydrocodone/acetaminophen (maximum could not exceed 8 tablets per 24 hours of the 5/500 mg tablets [40 mg hydrocodone and 4000 mg acetaminophen]) or similar medication as determined by the Investigator for pain until discharge. If oral medication was insufficient for control of pain, IM or IV morphine could be administered.
Measured: 0 to 48 hours postoperatively
The Total Amount of Opioid Rescue Analgesia Used
Higher score means worse outcome. Higher number means more Analgesia was needed. For the first 24 hours after surgery, patients received IV morphine via a PCA pump as rescue analgesia. Patient demand for morphine was recorded. After 24 hours, patients were offered hydrocodone/acetaminophen (maximum could not exceed 8 tablets per 24 hours of the 5/500 mg tablets [40 mg hydrocodone and 4000 mg acetaminophen]) or similar medication as determined by the Investigator for pain until discharge. If oral medication was insufficient for control of pain, IM or IV morphine could be administered.
Measured: 0 to 96 hours postoperatively
Total Use of Opioid Rescue Analgesia (mg) Over 0 to 72 Hours
Higher score means worse outcome. Higher number means more Analgesia was needed. For the first 24 hours after surgery, patients received IV morphine via a PCA pump as rescue analgesia. Patient demand for morphine was recorded. After 24 hours, patients were offered hydrocodone/acetaminophen (maximum could not exceed 8 tablets per 24 hours of the 5/500 mg tablets [40 mg hydrocodone and 4000 mg acetaminophen]) or similar medication as determined by the Investigator for pain until discharge. If oral medication was insufficient for control of pain, IM or IV morphine could be administered.
Measured: 0 to 72 Hours
Time to First Use of Opioid Rescue Analgesia
Higher score has a better outcome
Measured: 0 to 72 hours
VAS Pain Intensity Scores Over Time AT REST
For the VAS assessment, patients measured their pain intensity at rest using a horizontal 100-mm VAS scale labeled as follows: No Pain (0 mm) as the left anchor and Worst Pain Imaginable (100 mm) as the right anchor.
Measured: Hour 1, 1.5, 2,3,6,9,12,18,24,36,48,72,96
VAS (mm) Pain Intensity Scores Over Time (After Cough)
For the VAS assessment, patients measured their pain intensity after aggravated movement (cough) using a horizontal 100-mm VAS scale labeled as follows: No Pain (0 mm) as the left anchor and Worst Pain Imaginable (100 mm) as the right anchor.
Measured: Hour 1, 1.5, 2,3,6,9,12,18,24,36,48,72,96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Sep 200822 Dec 2008

First posted9 Sep 2008 (estimated)
Study start10 Sep 2008
Primary completion22 Dec 2008
Study completion22 Dec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00749749
Sponsor's protocol ID: INN-CB-005
Status last verified: Nov 2020
First submitted: 8 Sep 2008
Last updated: 4 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 23152696

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00749749
Acronym / sponsor ID: INN-CB-005
Conditions: Pain, Postoperative
Keywords: Abdominal Hysterectomy, Postoperative pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: InnocollIndustry (pharma, biotech, devices)
Collaborators: Premier Research
Study start: 10 Sep 2008
Primary completion: 22 Dec 2008 (actual)
Study completion: 22 Dec 2008 (actual)
First posted: 9 Sep 2008 (estimated)
Results: Posted 4 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Bupivacaine collagen sponge	Experimental	Drug: Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant)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.
ON-ON-Q PainBuster Post-op Pain relief SystemQ system	Active comparator	Drug: ON-Q PainBuster Post-op Pain relief SystemInsertion of the ON-Q system catheter into the deep subcutaneous space overlying the fascia.

Who may qualify

Ages: 18 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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:
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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant)Also: CollRx Bupivacaine ImplantThe bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride	Drug	Bupivacaine collagen sponge
ON-Q PainBuster Post-op Pain relief System5 mL/hr per catheter of 0.25% bupivacaine (12.5 mg) for 72 hours(total dose 360 mL [900 mg])	Drug	ON-ON-Q PainBuster Post-op Pain relief SystemQ system

Primary outcome

Total Amount of Opioid Rescue Analgesia Used
Time frame: 0 to 24 hours postoperatively
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

6 secondary outcomes

Total Amount of Opioid Rescue Analgesia Used
Time frame: 0 to 48 hours postoperatively
The Total Amount of Opioid Rescue Analgesia Used
Time frame: 0 to 96 hours postoperatively
Total Use of Opioid Rescue Analgesia (mg) Over 0 to 72 Hours
Time frame: 0 to 72 Hours
Time to First Use of Opioid Rescue Analgesia
Time frame: 0 to 72 hours
VAS Pain Intensity Scores Over Time AT REST
Time frame: Hour 1, 1.5, 2,3,6,9,12,18,24,36,48,72,96
VAS (mm) Pain Intensity Scores Over Time (After Cough)
Time frame: Hour 1, 1.5, 2,3,6,9,12,18,24,36,48,72,96

Results and safety

Results posted to the registry on 4 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bupivacaine Collagen Sponge	14	14
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System	13	13

Primary outcome: Total Amount of Opioid Rescue Analgesia Used

Time frame: 0 to 24 hours postoperatively. Mean (Standard Deviation). Unit: Morphine Milligrams

Measure	Bupivacaine Collagen Sponge n = 14	ON-ON-Q PainBuster Post-op Pain Relief SystemQ System n = 13
Value	46.85 (21.57)	67.03 (32.416)

Population analysed: Intent-to-Treat Population

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Information regarding AEs was collected from the time of hospital admission through Day 30. Normal postoperative sequelae were not considered to be AEs unless they occurred in a more severe form, as judged by the Investigator. Information on AEs was also collected during the Day 8 and Day 30 follow-up calls.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bupivacaine Collagen Sponge	0 of 14 (0%)	7 of 14 (50%)	0 of 14
ON-ON-Q PainBuster Post-op Pain Relief SystemQ System	0 of 13 (0%)	9 of 13 (69.2%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23152696Cusack 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Prior study director

Innocoll

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Amount of Opioid Rescue Analgesia Used (time frame: 0 to 24 hours postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00749749, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.