Postoperative Pain
Conditions
Keywords
Post Operative Pain, Hysterectomy
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 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.
Interventions
DRUGBupivacaine 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.
DRUGplacebo
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.
Sponsors
Premier Research
Innocoll
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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: 1. Laparoscopic procedures or supraumbilical or Maylard incisions will not be allowed 2. 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 3. 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) * 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
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Use of Opioid Rescue Analgesia | 0 to 24 hours postoperatively | Total use of opioid rescue analgesia (mg equivalent) -higher score means more analgesia was needed and worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Rating on a Visual Analog Scale (at Rest) | At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operatively | 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. |
| Time to First Use of Opioid Rescue Analgesia | Actual time assessed during post operative period | Time to first use of opioid rescue analgesia - lower number means worse outcome |
| Total Use of Opioid Rescue Analgesia | 0 to 48 hours postoperatively | Total use of opioid rescue analgesia (mg equivalent) -higher score means more analgesia was needed and worse outcome |
| Pain Intensity Rating on a 4-point Likert Scale (at Rest) | At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operatively | 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. |
| Pain Intensity Rating on a 4-point Likert Scale (After Cough) | At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operatively | 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. |
| Pain Intensity Rating on a Visual Analog Scale (After Cough) | At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operatively | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| 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. | 15 |
| Standard of Care no Implant The patient will receive the standard of care, but no implant during surgery | 11 |
| Total | 54 |
Baseline characteristics
| Characteristic | Bupivacaine Sponges | Collagen Sponges | Standard of Care no Implant | Total |
|---|---|---|---|---|
| Age, Continuous | 43.3 years STANDARD_DEVIATION 6.87 | 39.7 years STANDARD_DEVIATION 7.06 | 42.9 years STANDARD_DEVIATION 6.17 | 42.2 years STANDARD_DEVIATION 42.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 7 Participants | 3 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 7 Participants | 7 Participants | 35 Participants |
| Sex: Female, Male Female | 28 Participants | 15 Participants | 11 Participants | 54 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 15 | 0 / 11 |
| other Total, other adverse events | 21 / 28 | 12 / 15 | 9 / 11 |
| serious Total, serious adverse events | 2 / 28 | 0 / 15 | 1 / 11 |
Outcome results
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
Time frame: 0 to 24 hours postoperatively
Population: Intent-to-Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine Sponges | Total Use of Opioid Rescue Analgesia | 53.65 mg morphine equivalents | Standard Deviation 32.78 |
| Collagen Sponges | Total Use of Opioid Rescue Analgesia | 66.56 mg morphine equivalents | Standard Deviation 47.53 |
| Standard of Care no Implant | Total Use of Opioid Rescue Analgesia | 53.73 mg morphine equivalents | Standard Deviation 47.71 |
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.
Time frame: At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operatively
Population: Intent-to-Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupivacaine Sponges | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 18 | 1.8 score on a scale | Standard Deviation 0.73 |
| Bupivacaine Sponges | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 3.0 | 2.1 score on a scale | Standard Deviation 0.8 |
| Bupivacaine Sponges | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 1.0 | 2.2 score on a scale | Standard Deviation 0.95 |
| Bupivacaine Sponges | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 12 | 1.9 score on a scale | Standard Deviation 0.91 |
| Bupivacaine Sponges | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 6.0 | 1.8 score on a scale | Standard Deviation 0.75 |
| Bupivacaine Sponges | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 0.5 | 2.1 score on a scale | Standard Deviation 1.02 |
| Bupivacaine Sponges | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 9.0 | 1.9 score on a scale | Standard Deviation 0.74 |
| Bupivacaine Sponges | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 36 | 1.8 score on a scale | Standard Deviation 0.87 |
| Bupivacaine Sponges | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 1.5 | 2.2 score on a scale | Standard Deviation 0.83 |
| Bupivacaine Sponges | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 72 | 1.3 score on a scale | Standard Deviation 0.68 |
| Bupivacaine Sponges | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 24 | 1.7 score on a scale | Standard Deviation 0.76 |
| Bupivacaine Sponges | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 2.0 | 2.2 score on a scale | Standard Deviation 0.66 |
| Bupivacaine Sponges | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 48 | 1.5 score on a scale | Standard Deviation 0.84 |
| Collagen Sponges | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 72 | 1.3 score on a scale | Standard Deviation 0.49 |
| Collagen Sponges | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 0.5 | 2.2 score on a scale | Standard Deviation 0.83 |
| Collagen Sponges | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 1.0 | 2.5 score on a scale | Standard Deviation 0.78 |
| Collagen Sponges | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 1.5 | 2.2 score on a scale | Standard Deviation 0.8 |
| Collagen Sponges | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 2.0 | 2.0 score on a scale | Standard Deviation 0.93 |
| Collagen Sponges | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 3.0 | 2.1 score on a scale | Standard Deviation 0.88 |
| Collagen Sponges | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 6.0 | 2.1 score on a scale | Standard Deviation 0.74 |
| Collagen Sponges | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 9.0 | 2.1 score on a scale | Standard Deviation 0.8 |
| Collagen Sponges | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 12 | 1.8 score on a scale | Standard Deviation 0.69 |
| Collagen Sponges | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 18 | 1.9 score on a scale | Standard Deviation 0.74 |
| Collagen Sponges | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 24 | 1.8 score on a scale | Standard Deviation 0.77 |
| Collagen Sponges | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 36 | 1.4 score on a scale | Standard Deviation 0.76 |
| Collagen Sponges | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 48 | 1.5 score on a scale | Standard Deviation 0.92 |
| Standard of Care no Implant | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 2.0 | 2.3 score on a scale | Standard Deviation 0.79 |
| Standard of Care no Implant | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 0.5 | 2.4 score on a scale | Standard Deviation 0.84 |
| Standard of Care no Implant | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 18 | 1.7 score on a scale | Standard Deviation 0.76 |
| Standard of Care no Implant | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 1.5 | 2.5 score on a scale | Standard Deviation 0.69 |
| Standard of Care no Implant | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 72 | 1.3 score on a scale | Standard Deviation 0.79 |
| Standard of Care no Implant | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 24 | 1.9 score on a scale | Standard Deviation 0.57 |
| Standard of Care no Implant | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 1.0 | 2.4 score on a scale | Standard Deviation 0.84 |
| Standard of Care no Implant | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 6.0 | 2.1 score on a scale | Standard Deviation 0.57 |
| Standard of Care no Implant | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 48 | 1.5 score on a scale | Standard Deviation 0.69 |
| Standard of Care no Implant | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 9.0 | 2.2 score on a scale | Standard Deviation 0.67 |
| Standard of Care no Implant | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 3.0 | 2.2 score on a scale | Standard Deviation 0.79 |
| Standard of Care no Implant | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 36 | 1.9 score on a scale | Standard Deviation 0.74 |
| Standard of Care no Implant | Pain Intensity Rating on a 4-point Likert Scale (After Cough) | Hour 12 | 2.0 score on a scale | Standard Deviation 0.58 |
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.
Time frame: At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operatively
Population: Intent-to-Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupivacaine Sponges | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 48 | 1.1 score on a scale | Standard Deviation 0.63 |
| Bupivacaine Sponges | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 18 | 1.5 score on a scale | Standard Deviation 0.51 |
| Bupivacaine Sponges | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 6.0 | 1.5 score on a scale | Standard Deviation 0.64 |
| Bupivacaine Sponges | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 1.5 | 2.0 score on a scale | Standard Deviation 0.79 |
| Bupivacaine Sponges | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 12 | 1.4 score on a scale | Standard Deviation 0.75 |
| Bupivacaine Sponges | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 9.0 | 1.4 score on a scale | Standard Deviation 0.63 |
| Bupivacaine Sponges | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 0.5 | 1.8 score on a scale | Standard Deviation 1 |
| Bupivacaine Sponges | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 1.0 | 2.0 score on a scale | Standard Deviation 0.95 |
| Bupivacaine Sponges | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 36 | 1.3 score on a scale | Standard Deviation 0.82 |
| Bupivacaine Sponges | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 2.0 | 2.0 score on a scale | Standard Deviation 0.62 |
| Bupivacaine Sponges | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 72 | 0.9 score on a scale | Standard Deviation 0.69 |
| Bupivacaine Sponges | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 24 | 1.3 score on a scale | Standard Deviation 0.75 |
| Bupivacaine Sponges | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 3.0 | 1.7 score on a scale | Standard Deviation 0.71 |
| Collagen Sponges | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 9.0 | 1.5 score on a scale | Standard Deviation 0.83 |
| Collagen Sponges | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 0.5 | 2.0 score on a scale | Standard Deviation 1 |
| Collagen Sponges | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 1.0 | 2.2 score on a scale | Standard Deviation 0.69 |
| Collagen Sponges | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 1.5 | 2.0 score on a scale | Standard Deviation 0.88 |
| Collagen Sponges | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 2.0 | 1.7 score on a scale | Standard Deviation 0.7 |
| Collagen Sponges | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 3.0 | 1.6 score on a scale | Standard Deviation 0.74 |
| Collagen Sponges | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 6.0 | 1.3 score on a scale | Standard Deviation 0.96 |
| Collagen Sponges | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 12 | 1.1 score on a scale | Standard Deviation 0.64 |
| Collagen Sponges | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 18 | 1.1 score on a scale | Standard Deviation 0.74 |
| Collagen Sponges | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 24 | 1.1 score on a scale | Standard Deviation 0.7 |
| Collagen Sponges | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 36 | 0.8 score on a scale | Standard Deviation 0.43 |
| Collagen Sponges | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 48 | 0.9 score on a scale | Standard Deviation 0.7 |
| Collagen Sponges | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 72 | 0.6 score on a scale | Standard Deviation 0.63 |
| Standard of Care no Implant | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 18 | 1.4 score on a scale | Standard Deviation 0.79 |
| Standard of Care no Implant | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 2.0 | 2.0 score on a scale | Standard Deviation 0.77 |
| Standard of Care no Implant | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 48 | 0.9 score on a scale | Standard Deviation 0.83 |
| Standard of Care no Implant | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 24 | 1.5 score on a scale | Standard Deviation 0.82 |
| Standard of Care no Implant | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 1.5 | 2.1 score on a scale | Standard Deviation 0.83 |
| Standard of Care no Implant | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 0.5 | 2.2 score on a scale | Standard Deviation 1.03 |
| Standard of Care no Implant | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 36 | 1.4 score on a scale | Standard Deviation 0.52 |
| Standard of Care no Implant | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 9.0 | 1.8 score on a scale | Standard Deviation 0.83 |
| Standard of Care no Implant | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 6.0 | 1.6 score on a scale | Standard Deviation 0.52 |
| Standard of Care no Implant | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 1.0 | 2.2 score on a scale | Standard Deviation 0.79 |
| Standard of Care no Implant | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 12 | 1.7 score on a scale | Standard Deviation 0.76 |
| Standard of Care no Implant | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 3.0 | 1.9 score on a scale | Standard Deviation 0.88 |
| Standard of Care no Implant | Pain Intensity Rating on a 4-point Likert Scale (at Rest) | Hour 72 | 1.1 score on a scale | Standard Deviation 0.7 |
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.
Time frame: At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operatively
Population: Intent-to-Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupivacaine Sponges | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 1.0 | 68.2 score on a scale | Standard Deviation 32.96 |
| Bupivacaine Sponges | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 1.5 | 68.2 score on a scale | Standard Deviation 29.49 |
| Bupivacaine Sponges | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 2.0 | 66.0 score on a scale | Standard Deviation 24.96 |
| Bupivacaine Sponges | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 3.0 | 53.9 score on a scale | Standard Deviation 29.02 |
| Bupivacaine Sponges | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 6.0 | 48.3 score on a scale | Standard Deviation 27.73 |
| Bupivacaine Sponges | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 9.0 | 52.8 score on a scale | Standard Deviation 27.69 |
| Bupivacaine Sponges | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 12 | 52.5 score on a scale | Standard Deviation 24.56 |
| Bupivacaine Sponges | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 18 | 55.8 score on a scale | Standard Deviation 25.4 |
| Bupivacaine Sponges | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 24 | 46.8 score on a scale | Standard Deviation 26.65 |
| Bupivacaine Sponges | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 36 | 51.2 score on a scale | Standard Deviation 28.06 |
| Bupivacaine Sponges | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 48 | 40.7 score on a scale | Standard Deviation 29.3 |
| Bupivacaine Sponges | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 72 | 28.0 score on a scale | Standard Deviation 25.97 |
| Collagen Sponges | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 72 | 28.6 score on a scale | Standard Deviation 27.94 |
| Collagen Sponges | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 1.0 | 73.8 score on a scale | Standard Deviation 33.55 |
| Collagen Sponges | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 12 | 49.1 score on a scale | Standard Deviation 26.22 |
| Collagen Sponges | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 24 | 52.0 score on a scale | Standard Deviation 32.14 |
| Collagen Sponges | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 1.5 | 67.3 score on a scale | Standard Deviation 34.05 |
| Collagen Sponges | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 9.0 | 49.8 score on a scale | Standard Deviation 29.12 |
| Collagen Sponges | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 48 | 46.8 score on a scale | Standard Deviation 27.24 |
| Collagen Sponges | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 2.0 | 61.3 score on a scale | Standard Deviation 32.17 |
| Collagen Sponges | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 18 | 46.7 score on a scale | Standard Deviation 28.79 |
| Collagen Sponges | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 6.0 | 64.7 score on a scale | Standard Deviation 31.63 |
| Collagen Sponges | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 3.0 | 58.0 score on a scale | Standard Deviation 32.82 |
| Collagen Sponges | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 36 | 32.0 score on a scale | Standard Deviation 23.81 |
| Standard of Care no Implant | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 3.0 | 59.0 score on a scale | Standard Deviation 30.29 |
| Standard of Care no Implant | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 6.0 | 53.2 score on a scale | Standard Deviation 29.86 |
| Standard of Care no Implant | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 36 | 58.2 score on a scale | Standard Deviation 34.69 |
| Standard of Care no Implant | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 9.0 | 63.1 score on a scale | Standard Deviation 22.64 |
| Standard of Care no Implant | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 12 | 55.0 score on a scale | Standard Deviation 27.19 |
| Standard of Care no Implant | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 18 | 45.3 score on a scale | Standard Deviation 28.08 |
| Standard of Care no Implant | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 48 | 38.0 score on a scale | Standard Deviation 27.8 |
| Standard of Care no Implant | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 1.0 | 72.6 score on a scale | Standard Deviation 31.01 |
| Standard of Care no Implant | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 1.5 | 73.8 score on a scale | Standard Deviation 27.44 |
| Standard of Care no Implant | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 24 | 59.1 score on a scale | Standard Deviation 30.58 |
| Standard of Care no Implant | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 2.0 | 72.9 score on a scale | Standard Deviation 26.08 |
| Standard of Care no Implant | Pain Intensity Rating on a Visual Analog Scale (After Cough) | Hour 72 | 40.1 score on a scale | Standard Deviation 30.85 |
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.
Time frame: At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours post operatively
Population: Intent-to-Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupivacaine Sponges | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 1.0 | 58.5 score on a scale | Standard Deviation 33.59 |
| Bupivacaine Sponges | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 1.5 | 60.1 score on a scale | Standard Deviation 29.88 |
| Bupivacaine Sponges | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 2.0 | 54.2 score on a scale | Standard Deviation 23.92 |
| Bupivacaine Sponges | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 3.0 | 47.0 score on a scale | Standard Deviation 28.27 |
| Bupivacaine Sponges | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 6.0 | 38.5 score on a scale | Standard Deviation 24.47 |
| Bupivacaine Sponges | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 9.0 | 36.2 score on a scale | Standard Deviation 25.22 |
| Bupivacaine Sponges | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 12 | 36.1 score on a scale | Standard Deviation 24.79 |
| Bupivacaine Sponges | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 18 | 41.6 score on a scale | Standard Deviation 22.45 |
| Bupivacaine Sponges | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 24 | 33.3 score on a scale | Standard Deviation 24.71 |
| Bupivacaine Sponges | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 36 | 32.6 score on a scale | Standard Deviation 23.27 |
| Bupivacaine Sponges | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 48 | 26.4 score on a scale | Standard Deviation 20.41 |
| Bupivacaine Sponges | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 72 | 18.6 score on a scale | Standard Deviation 16.03 |
| Collagen Sponges | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 72 | 14.7 score on a scale | Standard Deviation 17.43 |
| Collagen Sponges | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 1.0 | 63.0 score on a scale | Standard Deviation 30.08 |
| Collagen Sponges | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 12 | 32.4 score on a scale | Standard Deviation 26.4 |
| Collagen Sponges | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 24 | 32.0 score on a scale | Standard Deviation 31.07 |
| Collagen Sponges | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 1.5 | 61.3 score on a scale | Standard Deviation 31.48 |
| Collagen Sponges | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 9.0 | 39.9 score on a scale | Standard Deviation 31.49 |
| Collagen Sponges | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 48 | 26.7 score on a scale | Standard Deviation 26.91 |
| Collagen Sponges | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 2.0 | 50.3 score on a scale | Standard Deviation 28.93 |
| Collagen Sponges | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 18 | 29.8 score on a scale | Standard Deviation 29.78 |
| Collagen Sponges | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 6.0 | 43.3 score on a scale | Standard Deviation 32.49 |
| Collagen Sponges | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 3.0 | 46.2 score on a scale | Standard Deviation 31.8 |
| Collagen Sponges | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 36 | 18.7 score on a scale | Standard Deviation 18.4 |
| Standard of Care no Implant | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 3.0 | 46.4 score on a scale | Standard Deviation 31.57 |
| Standard of Care no Implant | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 6.0 | 34.7 score on a scale | Standard Deviation 27.17 |
| Standard of Care no Implant | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 36 | 41.8 score on a scale | Standard Deviation 39.03 |
| Standard of Care no Implant | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 9.0 | 44.0 score on a scale | Standard Deviation 31.07 |
| Standard of Care no Implant | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 12 | 38.4 score on a scale | Standard Deviation 32.21 |
| Standard of Care no Implant | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 18 | 24.0 score on a scale | Standard Deviation 24.64 |
| Standard of Care no Implant | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 48 | 22.2 score on a scale | Standard Deviation 29.41 |
| Standard of Care no Implant | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 1.0 | 66.5 score on a scale | Standard Deviation 30.29 |
| Standard of Care no Implant | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 1.5 | 61.3 score on a scale | Standard Deviation 32.68 |
| Standard of Care no Implant | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 24 | 41.7 score on a scale | Standard Deviation 39.29 |
| Standard of Care no Implant | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 2.0 | 61.9 score on a scale | Standard Deviation 28.39 |
| Standard of Care no Implant | Pain Intensity Rating on a Visual Analog Scale (at Rest) | Hour 72 | 27.7 score on a scale | Standard Deviation 29.57 |
Secondary
Time to First Use of Opioid Rescue Analgesia
Time to first use of opioid rescue analgesia - lower number means worse outcome
Time frame: Actual time assessed during post operative period
Population: Intent-to-Treat Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bupivacaine Sponges | Time to First Use of Opioid Rescue Analgesia | 0.9 Time (Hours) |
| Collagen Sponges | Time to First Use of Opioid Rescue Analgesia | 0.9 Time (Hours) |
| Standard of Care no Implant | Time to First Use of Opioid Rescue Analgesia | 0.4 Time (Hours) |
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
Time frame: 0 to 72 hours postoperatively
Population: Intent-to-Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine Sponges | Total Use of Opioid Rescue Analgesia | 78.13 mg morphine equivalents | Standard Deviation 40.304 |
| Collagen Sponges | Total Use of Opioid Rescue Analgesia | 88.60 mg morphine equivalents | Standard Deviation 55.84 |
| Standard of Care no Implant | Total Use of Opioid Rescue Analgesia | 73.28 mg morphine equivalents | Standard Deviation 36.308 |
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
Time frame: 0 to 48 hours postoperatively
Population: Intent-to-Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine Sponges | Total Use of Opioid Rescue Analgesia | 67.78 mg morphine equivalents | Standard Deviation 37.195 |
| Collagen Sponges | Total Use of Opioid Rescue Analgesia | 80.87 mg morphine equivalents | Standard Deviation 51.085 |
| Standard of Care no Implant | Total Use of Opioid Rescue Analgesia | 66.03 mg morphine equivalents | Standard Deviation 32.41 |