Postoperative PainPhase 2NCT00624910
Efficacy and Safety of a Collagen Bupivacaine Implant in Women Following Abdominal Hysterectomy
A Phase 2 study testing Bupivacaine Collagen Sponge (CollaRx®) in people with Postoperative Pain, run by Innocoll at 1 site in United States.
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 24 hours after abdominal hysterectomy surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bupivacaine Collagen Sponge (CollaRx®)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2007to 5 Sep 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
- Have a body mass index (BMI) > 19 and < 40 kg/m2
- Had planned an elective total abdominal hysterectomy for reasons other than malignancies 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 non-hysterectomy gynecological procedures (such as myomectomy or adnexal surgery) is acceptable if the surgical indication is not to treat pelvic pain
- No concomitant vaginal procedures are allowed. An abdominal urethropexy and an incidental appendectomy will be allowed
- Have a risk classification of I, II or III according to the American Society of Anesthesiologists (ASA)
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- Have a negative pregnancy test
- Be free of other physical or mental conditions which may confound assessment of postoperative pain
- Have the ability to read, understand and comply with the study procedures and the use of the pain scales; is capable of operating a patient-controlled analgesia (PCA) device; and is able to communicate meaningfully with the study staff
- Voluntarily sign and date an informed consent form (ICF), prior to the conduct of any study-specific procedures
- Able to fluently speak and understand English and be able to provide meaningful written informed consent for the study
Who cannot join
- Known hypersensitivity to any active or inactive ingredient of the test articles
- Presence of clinically significant cardiac arrhythmias or atrioventricular (AV) conduction disorders
- Concomitant use of other amide local anesthetics
- Concomitant use of antiarrhythmics
- Concomitant use of propanolol
- Concomitant use of strong/moderate CYP3A4 inhibitors or inducers
Show all 29Show fewer
- Has used aspirin or aspirin-containing products within 7 days of surgery.
- Previous major surgery in the last 3 months
- Requires any additional surgical procedures during the same hospitalization (except as noted)
- Received neuraxial (spinal or epidural) opioid analgesics either prior to or during surgery
- Received local anesthetic infiltration of the surgical wound prior to, during or immediately after closure
- Is scheduled to receive local anesthetics via an indwelling catheter after surgery
- Underwent additional procedures during surgery, which may increase the visceral pain
- Has known or suspected history of alcohol or drug abuse or misuse or evidence for tolerance or physical dependency on opioids analgesics or sedative-hypnotic medications
- Uses opioids or tramadol daily for > 7 days prior to test article administration
- Has impaired liver function
- Has any clinically significant unstable condition that could compromise the patient's welfare
- Is at risk for infection or slow wound healing
- Has a chronic painful condition that might confound the assessment of pain associated with the sugery
- Has taken pain medication that could confound the analgesic responses the day of surgery
- Has been treated within 2 weeks of surgery with agents that could affect the analgesic response
- Has been treated with monoamine oxidase inhibitors (MAOIs) or MAOIs have been stopped fewer than 10 days prior to surgery
- Has been treated with corticosteroids or whose treatment with these has been stopped < 7 days prior surgery (inhaled corticosteroids are acceptable)
- Has participated in a clinical trial in the previous 30 days
- Has been hemodynamically unstable at any point in the previous 4 weeks or becomes hemodynamically unstable during surgery
- Required blood transfusion in the previous month, except as related to uterine bleeding caused by uterine fibroids.
- Has hemoglobin levels < 10 g/dL or < 8 g/dL for patients with an anemia secondary to heavy uterine bleeding caused by uterine fibroids.
- Has platelet count < 100,000/mm
- Unreliable or incapable of complying with the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Forsyth Medical Centre - OB Anesthesia
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase II, Single-dose, Blinded, Prospective Study to Investigate the Efficacy and Safety of the CollaRx® Bupivacaine Implant in Women Following Abdominal Hysterectomy or Other Nonlaparoscopic Benign Gynecological Procedure
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 24 hours after abdominal hysterectomy surgery.
Read the detailed description
Hysterectomy is the second most common surgery among women in the United States (US). According to the National Center for Health Statistics, there were 617,000 hysterectomies performed in the US in 2004. Effective postoperative pain management after hysterectomy is important in ensuring that surgical subjects have a smooth and successful recovery after their operation. Morphine and other narcotic pain medications are often used to help control pain after hysterectomy, but the large quantities required can lead to fatigue, nausea and vomiting, as well as the inability to walk around much because of drowsiness. Reducing narcotic pain medication use can reduce these negative side effects.
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 compare the amount of narcotic pain medication required after surgery in patients who receive the CollaRx Bupivacaine implant, a plain collagen implant or no implant at all.
- Conditions
- Postoperative Pain
- Being tested
- Bupivacaine Collagen Sponge (CollaRx®), placebo
- Keywords
- Post Operative Pain, Hysterectomy
- 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®)Drug
Also called CollRx Bupivacaine Implant
The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
placeboDrug
The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure Receives: Drug: Bupivacaine Collagen Sponge (CollaRx®) |
| 2 | Placebo comparator | A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure Receives: Drug: placebo |
| 3 | No intervention | The patient will recieve the standard of care, but no implant during surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Use of Opioid Rescue Analgesia
Total use of opioid rescue analgesia (mg equivalent) -higher score means more analgesia was needed and worse outcome
Measured: 0 to 24 hours postoperatively
Secondary outcomes (7)
Total Use of Opioid Rescue Analgesia
Total use of opioid rescue analgesia (mg equivalent) -higher score means more analgesia was needed and worse outcome
Measured: 0 to 48 hours postoperatively
Total Use of Opioid Rescue Analgesia
Total use of opioid rescue analgesia (mg equivalent) -higher score means more analgesia was needed and worse outcome
Measured: 0 to 72 hours postoperatively
Pain Intensity Rating on a Visual Analog Scale (at Rest)
Pain intensity rating on a Visual Analog Scale (at rest). Lowest score possible is "0" with the highest score possible being "100". Higher number means more pain reported.
Measured: At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operatively
Time to First Use of Opioid Rescue Analgesia
Time to first use of opioid rescue analgesia - lower number means worse outcome
Measured: Actual time assessed during post operative period
Pain Intensity Rating on a Visual Analog Scale (After Cough)
Pain intensity rating on a Visual Analog Scale (after cough). Lowest score possible is "0" with the highest score possible being "100". Higher number means more pain reported.
Measured: At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operatively
Pain Intensity Rating on a 4-point Likert Scale (at Rest)
For the 4-point categorical scale assessment, patients measured their pain intensity at rest using a numerical scale where: 0 = "none," 1 = "mild," 2 = "moderate" and 3 = "severe."
Measured: At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operatively
Pain Intensity Rating on a 4-point Likert Scale (After Cough)
For the 4-point categorical scale assessment, patients measured their pain intensity after aggravated movement (cough) using a numerical scale where: 0 = "none," 1 = "mild," 2 = "moderate" and 3 = "severe."
Measured: At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study start27 Dec 2007
- Primary completion5 Sep 2008
- Study completion5 Sep 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.
- Other trials for Postoperative PainStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innocoll
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Responsible party
- Sponsor
- Investigators
- David Prior, Study director, Innocoll
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624910
- Sponsor's protocol ID
- INN-CB-002
- Status last verified
- Jul 2021
- First submitted
- 19 Feb 2008
- Last updated
- 23 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-dose, Blinded, Prospective Study to Investigate the Efficacy and Safety of the CollaRx® Bupivacaine Implant in Women Following Abdominal Hysterectomy or Other Nonlaparoscopic Benign Gynecological Procedure
- ClinicalTrials.gov ID
- NCT00624910
- Acronym / sponsor ID
- INN-CB-002
- Conditions
- Postoperative Pain
- Keywords
- Post Operative Pain, Hysterectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- InnocollIndustry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- 27 Dec 2007 (actual)
- Primary completion
- 5 Sep 2008 (actual)
- Study completion
- 5 Sep 2008 (actual)
- First posted
- 28 Feb 2008 (estimated)
- Results
- Posted 12 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 24 hours after abdominal hysterectomy surgery.
Detailed description
Hysterectomy is the second most common surgery among women in the United States (US). According to the National Center for Health Statistics, there were 617,000 hysterectomies performed in the US in 2004. Effective postoperative pain management after hysterectomy is important in ensuring that surgical subjects have a smooth and successful recovery after their operation. Morphine and other narcotic pain medications are often used to help control pain after hysterectomy, but the large quantities required can lead to fatigue, nausea and vomiting, as well as the inability to walk around much because of drowsiness. Reducing narcotic pain medication use can reduce these negative side effects.
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 compare the amount of narcotic pain medication required after surgery in patients who receive the CollaRx Bupivacaine implant, a plain collagen implant or no implant at all.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Bupivacaine Collagen Sponge (CollaRx®)A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure |
| 2 | Placebo comparator | Drug: placeboA total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure |
| 3 | No intervention | –The patient will recieve the standard of care, but no implant during surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Have a body mass index (BMI) > 19 and < 40 kg/m2
- Had planned an elective total abdominal hysterectomy for reasons other than malignancies to be performed according to standard surgical technique using a standard incision and under general anesthesia with the following caveats:
- Have a risk classification of I, II or III according to the American Society of Anesthesiologists (ASA)
- Have a negative pregnancy test
- Be free of other physical or mental conditions which may confound assessment of postoperative pain
Key exclusion criteria (29 listed)
- Known hypersensitivity to any active or inactive ingredient of the test articles
- Presence of clinically significant cardiac arrhythmias or atrioventricular (AV) conduction disorders
- Concomitant use of other amide local anesthetics
- Concomitant use of antiarrhythmics
- Concomitant use of propanolol
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®)Also: CollRx Bupivacaine ImplantThe bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision. | Drug | 1 |
| placeboThe placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision. | Drug | 2 |
Primary outcome
Total Use of Opioid Rescue Analgesia
Time frame: 0 to 24 hours postoperatively
Total use of opioid rescue analgesia (mg equivalent) -higher score means more analgesia was needed and worse outcome
7 secondary outcomes
Total Use of Opioid Rescue Analgesia
Time frame: 0 to 48 hours postoperatively
Total Use of Opioid Rescue Analgesia
Time frame: 0 to 72 hours postoperatively
Pain Intensity Rating on a Visual Analog Scale (at Rest)
Time frame: At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operatively
Time to First Use of Opioid Rescue Analgesia
Time frame: Actual time assessed during post operative period
Pain Intensity Rating on a Visual Analog Scale (After Cough)
Time frame: At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operatively
Pain Intensity Rating on a 4-point Likert Scale (at Rest)
Time frame: At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operatively
Pain Intensity Rating on a 4-point Likert Scale (After Cough)
Time frame: At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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?
A Phase 2 study testing Bupivacaine Collagen Sponge (CollaRx®) in people with Postoperative Pain, run by Innocoll at 1 site in United States.
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 11 inclusion and 29 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 23 Jul 2021. 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. Some participants in this study may receive a placebo. 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 12 Jan 2021). 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 Use of Opioid Rescue Analgesia (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?
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 23 Jul 2021.