Pain, Postoperative
Conditions
Keywords
Abdominal Hysterectomy, Postoperative pain
Brief summary
The purpose of this study is to determine whether the CollaRx Bupivacaine Implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 96 hours after abdominal hysterectomy when compared to the ON-Q PainBuster Post-op Pain Relief System.
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.
Interventions
DRUGBupivacaine Collagen Sponge (CollaRx Bupivacaine Implant)
The bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride
5 mL/hr per catheter of 0.25% bupivacaine (12.5 mg) for 72 hours(total dose 360 mL \[900 mg\])
Sponsors
Premier Research
Innocoll
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Must be a woman who is ≥ 18 and ≤ 75 years of age. * Has a body mass index (BMI) \> 19 and \< 40 kg/m2. * Has planned an elective total abdominal hysterectomy for reasons other than malignancies (such as uterine adenocarcinoma, cervical cancer or leiomyosarcoma) to be performed according to standard surgical technique using a standard incision and under general anesthesia with the following caveats: * Laparoscopic procedures or supraumbilical or Maylard incisions will not be allowed. * A nonlaparoscopic incision for benign nonhysterectomy gynecological procedures (such as myomectomy or adnexal surgery) is acceptable if the surgical indication is not to treat pelvic pain. * No concomitant vaginal procedures such as anterior and posterior colporrhaphy (A&P repairs) are allowed. An abdominal urethropexy and an incidental appendectomy will be allowed. * Has a risk classification of I, II or III according to the American Society of Anesthesiologists (ASA). * Is nonpregnant (negative pregnancy test at Screening and Day 0 before surgery) and nonlactating. * Is free of other physical or mental conditions that, in the opinion of the Investigator, may confound quantification of postoperative pain resulting from the abdominal hysterectomy. * Has the ability to read, understand and comply with the study procedures and the use of the pain scales; is deemed capable of operating a patient controlled analgesia (PCA) device; and is able to communicate meaningfully with the study staff. * Must voluntarily sign and date an informed consent form (ICF), approved by an Institutional Review Board (IRB), prior to the conduct of any study specific procedures. * Must be able to fluently speak and understand English and be able to provide meaningful written informed consent for the study.
Exclusion criteria
* Has known hypersensitivity to amide local anesthetics, opioids, bovine products or to inactive ingredients of the test article or reference product. * Has cardiac arrhythmias or atrioventricular (AV) conduction disorders. * Concomitantly uses other amide local anesthetics. * Concomitantly uses antiarrhythmics (eg, amiodarone), propranolol or strong/moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers (eg, macrolide antibiotics and grapefruit juice). * Has used long acting analgesics within 24 hours of surgery. Short acting analgesics such as acetaminophen may be used on the day of surgery but are subject to preoperative restrictions for oral intake. * Has used aspirin or aspirin containing products within 7 days of surgery. Aspirin at a dose of ≤ 325 mg is allowed for cardiovascular prophylaxis if the patient has been on a stable dose regimen for ≥ 30 days prior to Screening. * Has undergone major surgery within 3 months of the scheduled hysterectomy. * Requires the use of Seprafilm® or other absorbable adhesion barriers for the scheduled hysterectomy. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Amount of Opioid Rescue Analgesia Used | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Total Amount of Opioid Rescue Analgesia Used | 0 to 96 hours postoperatively | 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. |
| Total Use of Opioid Rescue Analgesia (mg) Over 0 to 72 Hours | 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. |
| Total Amount of Opioid Rescue Analgesia Used | 0 to 48 hours postoperatively | 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. |
| VAS Pain Intensity Scores Over Time AT REST | Hour 1, 1.5, 2,3,6,9,12,18,24,36,48,72,96 | 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. |
| VAS (mm) Pain Intensity Scores Over Time (After Cough) | Hour 1, 1.5, 2,3,6,9,12,18,24,36,48,72,96 | 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. |
| Time to First Use of Opioid Rescue Analgesia | 0 to 72 hours | Higher score has a better outcome |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bupivacaine Collagen Sponge 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.
Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant): The bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride | 14 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System Insertion of the ON-Q system catheter into the deep subcutaneous space overlying the fascia.
ON-Q PainBuster Post-op Pain relief System: 5 mL/hr per catheter of 0.25% bupivacaine (12.5 mg) for 72 hours(total dose 360 mL \[900 mg\]) | 13 |
| Total | 27 |
Baseline characteristics
| Characteristic | ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | Total | Bupivacaine Collagen Sponge |
|---|---|---|---|
| Age, Continuous | 43.4 years STANDARD_DEVIATION 41 | 43.3 years STANDARD_DEVIATION 9.15 | 43.3 years STANDARD_DEVIATION 11.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 19 Participants | 11 Participants |
| Sex: Female, Male Female | 13 Participants | 27 Participants | 14 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 13 |
| other Total, other adverse events | 7 / 14 | 9 / 13 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 |
Outcome results
Primary
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
Time frame: 0 to 24 hours postoperatively
Population: Intent-to-Treat Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine Collagen Sponge | Total Amount of Opioid Rescue Analgesia Used | 46.85 Morphine Milligrams | Standard Deviation 21.57 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | Total Amount of Opioid Rescue Analgesia Used | 67.03 Morphine Milligrams | Standard Deviation 32.416 |
Secondary
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.
Time frame: 0 to 96 hours postoperatively
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine Collagen Sponge | The Total Amount of Opioid Rescue Analgesia Used | 67.87 Morphine equivalents | Standard Deviation 28.175 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | The Total Amount of Opioid Rescue Analgesia Used | 90.77 Morphine equivalents | Standard Deviation 46.114 |
Secondary
Time to First Use of Opioid Rescue Analgesia
Higher score has a better outcome
Time frame: 0 to 72 hours
Population: Intent-to-Treat Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bupivacaine Collagen Sponge | Time to First Use of Opioid Rescue Analgesia | 0.78 Hours |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | Time to First Use of Opioid Rescue Analgesia | 0.57 Hours |
Secondary
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.
Time frame: 0 to 48 hours postoperatively
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine Collagen Sponge | Total Amount of Opioid Rescue Analgesia Used | 55.43 Morphine equivalents | Standard Deviation 22.77 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | Total Amount of Opioid Rescue Analgesia Used | 74.85 Morphine equivalents | Standard Deviation 35.381 |
Secondary
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.
Time frame: 0 to 72 Hours
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupivacaine Collagen Sponge | Total Use of Opioid Rescue Analgesia (mg) Over 0 to 72 Hours | 61.98 Morphine equivalents | Standard Deviation 25.27 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | Total Use of Opioid Rescue Analgesia (mg) Over 0 to 72 Hours | 85.36 Morphine equivalents | Standard Deviation 41.887 |
Secondary
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.
Time frame: Hour 1, 1.5, 2,3,6,9,12,18,24,36,48,72,96
Population: Intent-to-Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupivacaine Collagen Sponge | VAS (mm) Pain Intensity Scores Over Time (After Cough) | Hour 2.0 | 73.8 units on a scale | Standard Deviation 26.25 |
| Bupivacaine Collagen Sponge | VAS (mm) Pain Intensity Scores Over Time (After Cough) | Hour 18 | 44.5 units on a scale | Standard Deviation 29.46 |
| Bupivacaine Collagen Sponge | VAS (mm) Pain Intensity Scores Over Time (After Cough) | hour 6.0 | 61.9 units on a scale | Standard Deviation 33.51 |
| Bupivacaine Collagen Sponge | VAS (mm) Pain Intensity Scores Over Time (After Cough) | Hour 24 | 49.3 units on a scale | Standard Deviation 32.63 |
| Bupivacaine Collagen Sponge | VAS (mm) Pain Intensity Scores Over Time (After Cough) | Hour 1.5 | 76.5 units on a scale | Standard Deviation 24.54 |
| Bupivacaine Collagen Sponge | VAS (mm) Pain Intensity Scores Over Time (After Cough) | Hour 36 | 47.0 units on a scale | Standard Deviation 32.11 |
| Bupivacaine Collagen Sponge | VAS (mm) Pain Intensity Scores Over Time (After Cough) | Hour 9.0 | 51.5 units on a scale | Standard Deviation 33.07 |
| Bupivacaine Collagen Sponge | VAS (mm) Pain Intensity Scores Over Time (After Cough) | Hour 48 | 34.2 units on a scale | Standard Deviation 27.31 |
| Bupivacaine Collagen Sponge | VAS (mm) Pain Intensity Scores Over Time (After Cough) | Hour 3.0 | 62.1 units on a scale | Standard Deviation 26.52 |
| Bupivacaine Collagen Sponge | VAS (mm) Pain Intensity Scores Over Time (After Cough) | Hour 72 | 27.4 units on a scale | Standard Deviation 24.79 |
| Bupivacaine Collagen Sponge | VAS (mm) Pain Intensity Scores Over Time (After Cough) | Hour 12 | 43.6 units on a scale | Standard Deviation 33.33 |
| Bupivacaine Collagen Sponge | VAS (mm) Pain Intensity Scores Over Time (After Cough) | Hour 96 | 27.1 units on a scale | Standard Deviation 23.7 |
| Bupivacaine Collagen Sponge | VAS (mm) Pain Intensity Scores Over Time (After Cough) | Hour 1 | 84.4 units on a scale | Standard Deviation 21.41 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | VAS (mm) Pain Intensity Scores Over Time (After Cough) | Hour 96 | 19.1 units on a scale | Standard Deviation 28.24 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | VAS (mm) Pain Intensity Scores Over Time (After Cough) | Hour 1 | 86.1 units on a scale | Standard Deviation 21.72 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | VAS (mm) Pain Intensity Scores Over Time (After Cough) | Hour 1.5 | 79.8 units on a scale | Standard Deviation 25.33 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | VAS (mm) Pain Intensity Scores Over Time (After Cough) | Hour 2.0 | 84.6 units on a scale | Standard Deviation 24.19 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | VAS (mm) Pain Intensity Scores Over Time (After Cough) | Hour 3.0 | 77.1 units on a scale | Standard Deviation 31.4 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | VAS (mm) Pain Intensity Scores Over Time (After Cough) | hour 6.0 | 65.8 units on a scale | Standard Deviation 28.5 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | VAS (mm) Pain Intensity Scores Over Time (After Cough) | Hour 9.0 | 52.5 units on a scale | Standard Deviation 28.08 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | VAS (mm) Pain Intensity Scores Over Time (After Cough) | Hour 12 | 38.9 units on a scale | Standard Deviation 25.87 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | VAS (mm) Pain Intensity Scores Over Time (After Cough) | Hour 18 | 50.7 units on a scale | Standard Deviation 30.59 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | VAS (mm) Pain Intensity Scores Over Time (After Cough) | Hour 24 | 40.3 units on a scale | Standard Deviation 26.04 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | VAS (mm) Pain Intensity Scores Over Time (After Cough) | Hour 36 | 27.8 units on a scale | Standard Deviation 20.27 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | VAS (mm) Pain Intensity Scores Over Time (After Cough) | Hour 48 | 27.9 units on a scale | Standard Deviation 19.67 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | VAS (mm) Pain Intensity Scores Over Time (After Cough) | Hour 72 | 34.6 units on a scale | Standard Deviation 30 |
Secondary
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.
Time frame: Hour 1, 1.5, 2,3,6,9,12,18,24,36,48,72,96
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupivacaine Collagen Sponge | VAS Pain Intensity Scores Over Time AT REST | Hour 2 | 61.5 units on a scale | Standard Deviation 26.92 |
| Bupivacaine Collagen Sponge | VAS Pain Intensity Scores Over Time AT REST | Hour 18 | 44.5 units on a scale | Standard Deviation 29.46 |
| Bupivacaine Collagen Sponge | VAS Pain Intensity Scores Over Time AT REST | Hour 6 | 49.9 units on a scale | Standard Deviation 32.15 |
| Bupivacaine Collagen Sponge | VAS Pain Intensity Scores Over Time AT REST | Hour 24 | 49.3 units on a scale | Standard Deviation 32.63 |
| Bupivacaine Collagen Sponge | VAS Pain Intensity Scores Over Time AT REST | Hour 1.5 | 66.3 units on a scale | Standard Deviation 24.96 |
| Bupivacaine Collagen Sponge | VAS Pain Intensity Scores Over Time AT REST | Hour 36 | 47.0 units on a scale | Standard Deviation 32.11 |
| Bupivacaine Collagen Sponge | VAS Pain Intensity Scores Over Time AT REST | Hour 9 | 38.1 units on a scale | Standard Deviation 29.37 |
| Bupivacaine Collagen Sponge | VAS Pain Intensity Scores Over Time AT REST | Hour 48 | 34.2 units on a scale | Standard Deviation 27.31 |
| Bupivacaine Collagen Sponge | VAS Pain Intensity Scores Over Time AT REST | Hour 3 | 52.2 units on a scale | Standard Deviation 21.71 |
| Bupivacaine Collagen Sponge | VAS Pain Intensity Scores Over Time AT REST | Hour 72 | 27.4 units on a scale | Standard Deviation 24.79 |
| Bupivacaine Collagen Sponge | VAS Pain Intensity Scores Over Time AT REST | Hour 12 | 43.6 units on a scale | Standard Deviation 33.33 |
| Bupivacaine Collagen Sponge | VAS Pain Intensity Scores Over Time AT REST | Hour 96 | 27.1 units on a scale | Standard Deviation 23.7 |
| Bupivacaine Collagen Sponge | VAS Pain Intensity Scores Over Time AT REST | Hour 1.0 | 75.2 units on a scale | Standard Deviation 21.32 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | VAS Pain Intensity Scores Over Time AT REST | Hour 96 | 19.1 units on a scale | Standard Deviation 28.24 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | VAS Pain Intensity Scores Over Time AT REST | Hour 1.0 | 74.5 units on a scale | Standard Deviation 22.75 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | VAS Pain Intensity Scores Over Time AT REST | Hour 1.5 | 66.5 units on a scale | Standard Deviation 28.65 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | VAS Pain Intensity Scores Over Time AT REST | Hour 2 | 68.6 units on a scale | Standard Deviation 26.52 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | VAS Pain Intensity Scores Over Time AT REST | Hour 3 | 60.9 units on a scale | Standard Deviation 29.85 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | VAS Pain Intensity Scores Over Time AT REST | Hour 6 | 45.8 units on a scale | Standard Deviation 24.49 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | VAS Pain Intensity Scores Over Time AT REST | Hour 9 | 35.8 units on a scale | Standard Deviation 24.48 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | VAS Pain Intensity Scores Over Time AT REST | Hour 12 | 38.9 units on a scale | Standard Deviation 25.87 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | VAS Pain Intensity Scores Over Time AT REST | Hour 18 | 50.7 units on a scale | Standard Deviation 30.59 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | VAS Pain Intensity Scores Over Time AT REST | Hour 24 | 40.3 units on a scale | Standard Deviation 26.04 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | VAS Pain Intensity Scores Over Time AT REST | Hour 36 | 27.8 units on a scale | Standard Deviation 20.27 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | VAS Pain Intensity Scores Over Time AT REST | Hour 48 | 27.9 units on a scale | Standard Deviation 19.67 |
| ON-ON-Q PainBuster Post-op Pain Relief SystemQ System | VAS Pain Intensity Scores Over Time AT REST | Hour 72 | 34.6 units on a scale | Standard Deviation 30 |