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| Name | Class |
|---|---|
| Premier Research | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure |
|
| 2 | Placebo Comparator | A 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Collagen Sponge (CollaRx®) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Use of Opioid Rescue Analgesia | Total use of opioid rescue analgesia (mg equivalent) -higher score means more analgesia was needed and worse outcome | 0 to 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Total Use of Opioid Rescue Analgesia | Total use of opioid rescue analgesia (mg equivalent) -higher score means more analgesia was needed and worse outcome | 0 to 48 hours postoperatively |
| Total Use of Opioid Rescue Analgesia |
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Inclusion Criteria:
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
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Prior | Innocoll | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forsyth Medical Centre - OB Anesthesia | Winston-Salem | North Carolina | 27103 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bupivacaine Sponges | A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure Bupivacaine Collagen Sponge (CollaRx®): 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. |
| FG001 | Collagen Sponges | A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure placebo: 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. |
| FG002 | Standard of Care no Implant | The patient will receive the standard of care, but no implant during surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intent-to-Treat Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Bupivacaine Sponges | A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure Bupivacaine Collagen Sponge (CollaRx®): 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Use of Opioid Rescue Analgesia | Total use of opioid rescue analgesia (mg equivalent) -higher score means more analgesia was needed and worse outcome | Intent-to-Treat Population | Posted | Mean | Standard Deviation | mg morphine equivalents | 0 to 24 hours postoperatively |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bupivacaine Sponges | A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure Bupivacaine Collagen Sponge (CollaRx®): 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charlene A. Tucker, MS Executive Director, Medical Writing and Document Management | Innocoll | 484-406-5211 | ctucker@innocoll.com |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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|
|
| placebo | Drug | 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. |
|
Total use of opioid rescue analgesia (mg equivalent) -higher score means more analgesia was needed and worse outcome
| 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. | 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 | 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. | 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." | 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." | At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operatively |
| BG001 | Collagen Sponges | A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure placebo: 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. |
| BG002 | Standard of Care no Implant | The patient will receive the standard of care, but no implant during surgery |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| Collagen Sponges |
A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure placebo: 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. |
| OG002 | Standard of Care no Implant | The patient will receive the standard of care, but no implant during surgery |
|
|
| Secondary | Total Use of Opioid Rescue Analgesia | Total use of opioid rescue analgesia (mg equivalent) -higher score means more analgesia was needed and worse outcome | Intent-to-Treat Population | Posted | Mean | Standard Deviation | mg morphine equivalents | 0 to 48 hours postoperatively |
|
|
|
| Secondary | Total Use of Opioid Rescue Analgesia | Total use of opioid rescue analgesia (mg equivalent) -higher score means more analgesia was needed and worse outcome | Intent-to-Treat Population | Posted | Mean | Standard Deviation | mg morphine equivalents | 0 to 72 hours postoperatively |
|
|
|
| Secondary | 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. | Intent-to-Treat Population | Posted | Mean | Standard Deviation | score on a scale | At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operatively |
|
|
|
| Secondary | Time to First Use of Opioid Rescue Analgesia | Time to first use of opioid rescue analgesia - lower number means worse outcome | Intent-to-Treat Population | Posted | Median | 95% Confidence Interval | Time (Hours) | Actual time assessed during post operative period |
|
|
|
| Secondary | 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. | Intent-to-Treat Population | Posted | Mean | Standard Deviation | score on a scale | At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operatively |
|
|
|
| Secondary | 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." | Intent-to-Treat Population | Posted | Mean | Standard Deviation | score on a scale | At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operatively |
|
|
|
| Secondary | 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." | Intent-to-Treat Population | Posted | Mean | Standard Deviation | score on a scale | At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operatively |
|
|
|
| 0 |
| 28 |
| 2 |
| 28 |
| 21 |
| 28 |
| EG001 | Collagen Sponges | A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure placebo: 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. | 0 | 15 | 0 | 15 | 12 | 15 |
| EG002 | Standard of Care no Implant | The patient will receive the standard of care, but no implant during surgery | 0 | 11 | 1 | 11 | 9 | 11 |
| Abdominal abscess | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Abdominal abscess | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Procedural hypertension | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Oxygen saturation decreased | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Hour 24 |
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| Hour 36 |
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| Hour 48 |
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| Hour 72 |
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