Herniorrhaphy, Inguinal Hernia, Postoperative Pain
Conditions
Brief summary
This study will assess pain intensity for the first 72 hrs after after aggravated movement (cough)following open laparotomy inguinal herniorrhaphy in patient who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.
Detailed description
Inguinal herniorrhaphy is a common surgery; and common surgical methods used include laparoscopic and open placement of synthetic mesh. The use of synthetic mesh can greatly reduce the risk of hernia recurrence regardless of the method used for its placement. Managing postoperative pain and preventing morbidity after open mesh herniorrhaphy remain considerable medical challenges. 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 assess pain intensity after surgery in patients who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.
Interventions
Drug: Bupivacaine Collagen Sponge
Drug: Placebo Collagen Sponge
Sponsors
Premier Research
Innocoll
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Man ≥ 18 years * Body mass index (BMI) ≥ 19 and ≤ 40 kg/m2. * Has a planned unilateral inguinal herniorrhaphy (open laparotomy, tension free technique) to be performed according to standard surgical technique under general anesthesia.
Exclusion criteria
* Has a known hypersensitivity to amide local anesthetics, opioids, or bovine products. * Scheduled for bilateral inguinal herniorrhaphy. * Undergone a prior herniorrhaphy on the side scheduled for repair. * Undergone major surgery within 3 mos of the scheduled herniorrhaphy. * Has cardiac arrhythmias or atrioventricular (AV) conduction disorders. * Concomitantly uses antiarrhythmics (eg, amiodarone, lidocaine), propranolol, or strong/moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers (eg, macrolide antibiotics and grapefruit juice). * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sum of Pain Intensity Defined as Area Under the Curve (AUC) of 100-mm VAS PI Scores. | 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours. | The primary efficacy variable was SPI defined as area under the curve (AUC) of 100-mm VAS pain intensity scores after aggravated movement (cough) from 1 to 72 hours after surgery. Minimum score is 0. Maximum score is 7200. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. A lower score means a better outcome or less pain reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sum of Pain Intensity (SPI) After Aggravated Movement (Cough) | 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours. | Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100) at each time point. A lower score is better which means the patient experience lower pain. The score is calculated using the number of hours \* the VAS score. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. For each measure outcome - the minimum score is 0 and the maximum score is 100\* the number of hours in that period. |
| Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest | 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours. | Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100) at each time point. A lower score is better which means the patient experience lower pain. The score is calculated using the number of hours \* the VAS score. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. For each measure outcome - the minimum score is 0 and the maximum score is 100\* the number of hours in that period. |
| Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) | 1,2,4,6,8,10,12,24,48 and 72 hours | Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100). Patients were asked during multiple time points to provide a score on this VAS scale. The lower the sore the better the outcome. Higher score is a worse outcome |
| Pain Intensity VAS Scores Over Time at Rest | 1,2,4,6,8,10,12,24,48 and 72 hours | Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100). Patients were asked during multiple time points to provide a score on this VAS scale. Lower score is better. Higher score means more pain. Time points are summarized independently |
| Mean Sum of Pain Intensity (SPI) Categorical Scores After Aggravated Movement | 1,2,4,6,8,10,12,24,48 and 72 hours | Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100) for each timepoint. (timepoints 1,2,4,6,8,10,12,24,48 and 72 hours ) Patients were asked during multiple time points to provide a score on this VAS scale. For 1 to 24 hours the highest score possible would be 800. For 1 to 48 hours the highest score possible would be 900. For 1 to 72 hours the highest score possible would be 1000. A mean Lower score is better. A mean Higher score is a worse outcome. |
Countries
United States
Participant flow
Recruitment details
medical investigative sites
Participants by arm
| Arm | Count |
|---|---|
| 2, 5x5cm Bupivacaine Collagen Sponges Bupivacaine Collagen Sponge: Drug: Bupivacaine Collagen Sponge | 25 |
| 2, Placebo Collagen Sponges Placebo collagen Sponge: Drug: Placebo Collagen Sponge | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | 2, 5x5cm Bupivacaine Collagen Sponges | 2, Placebo Collagen Sponges | Total |
|---|---|---|---|
| Age, Continuous | 47.8 years STANDARD_DEVIATION 12.3 | 41.7 years STANDARD_DEVIATION 14.9 | 44.7 years STANDARD_DEVIATION 13.9 |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 25 Participants | 25 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 15 / 25 | 17 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Sum of Pain Intensity Defined as Area Under the Curve (AUC) of 100-mm VAS PI Scores.
The primary efficacy variable was SPI defined as area under the curve (AUC) of 100-mm VAS pain intensity scores after aggravated movement (cough) from 1 to 72 hours after surgery. Minimum score is 0. Maximum score is 7200. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. A lower score means a better outcome or less pain reported.
Time frame: 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.
Population: Intent-to-treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2, 5x5cm Bupivacaine Collagen Sponges | Sum of Pain Intensity Defined as Area Under the Curve (AUC) of 100-mm VAS PI Scores. | 2810.4 score on a scale*hour | Standard Deviation 1693.43 |
| 2, Placebo Collagen Sponges | Sum of Pain Intensity Defined as Area Under the Curve (AUC) of 100-mm VAS PI Scores. | 3484.5 score on a scale*hour | Standard Deviation 1806.68 |
Secondary
Mean Sum of Pain Intensity (SPI) Categorical Scores After Aggravated Movement
Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100) for each timepoint. (timepoints 1,2,4,6,8,10,12,24,48 and 72 hours ) Patients were asked during multiple time points to provide a score on this VAS scale. For 1 to 24 hours the highest score possible would be 800. For 1 to 48 hours the highest score possible would be 900. For 1 to 72 hours the highest score possible would be 1000. A mean Lower score is better. A mean Higher score is a worse outcome.
Time frame: 1,2,4,6,8,10,12,24,48 and 72 hours
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2, 5x5cm Bupivacaine Collagen Sponges | Mean Sum of Pain Intensity (SPI) Categorical Scores After Aggravated Movement | 1 to 24 hours | 40.6 score on a scale | Standard Deviation 13.64 |
| 2, 5x5cm Bupivacaine Collagen Sponges | Mean Sum of Pain Intensity (SPI) Categorical Scores After Aggravated Movement | 1 to 48 hours | 83.3 score on a scale | Standard Deviation 29.63 |
| 2, 5x5cm Bupivacaine Collagen Sponges | Mean Sum of Pain Intensity (SPI) Categorical Scores After Aggravated Movement | 1 to 72 hours | 118.9 score on a scale | Standard Deviation 44.8 |
| 2, Placebo Collagen Sponges | Mean Sum of Pain Intensity (SPI) Categorical Scores After Aggravated Movement | 1 to 24 hours | 45.6 score on a scale | Standard Deviation 13.84 |
| 2, Placebo Collagen Sponges | Mean Sum of Pain Intensity (SPI) Categorical Scores After Aggravated Movement | 1 to 48 hours | 90.2 score on a scale | Standard Deviation 27.86 |
| 2, Placebo Collagen Sponges | Mean Sum of Pain Intensity (SPI) Categorical Scores After Aggravated Movement | 1 to 72 hours | 128.8 score on a scale | Standard Deviation 46.12 |
Secondary
Pain Intensity VAS Scores Over Time at Rest
Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100). Patients were asked during multiple time points to provide a score on this VAS scale. Lower score is better. Higher score means more pain. Time points are summarized independently
Time frame: 1,2,4,6,8,10,12,24,48 and 72 hours
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2, 5x5cm Bupivacaine Collagen Sponges | Pain Intensity VAS Scores Over Time at Rest | Hour 1 | 31.6 score on a scale | Standard Deviation 29.2 |
| 2, 5x5cm Bupivacaine Collagen Sponges | Pain Intensity VAS Scores Over Time at Rest | Hour 2 | 33.2 score on a scale | Standard Deviation 25.2 |
| 2, 5x5cm Bupivacaine Collagen Sponges | Pain Intensity VAS Scores Over Time at Rest | Hour 4 | 31.6 score on a scale | Standard Deviation 24.6 |
| 2, 5x5cm Bupivacaine Collagen Sponges | Pain Intensity VAS Scores Over Time at Rest | Hour 6 | 33.5 score on a scale | Standard Deviation 25.45 |
| 2, 5x5cm Bupivacaine Collagen Sponges | Pain Intensity VAS Scores Over Time at Rest | Hour 8 | 47.3 score on a scale | Standard Deviation 25.33 |
| 2, 5x5cm Bupivacaine Collagen Sponges | Pain Intensity VAS Scores Over Time at Rest | Hour 10 | 44.0 score on a scale | Standard Deviation 25.93 |
| 2, 5x5cm Bupivacaine Collagen Sponges | Pain Intensity VAS Scores Over Time at Rest | Hour 12 | 47.6 score on a scale | Standard Deviation 28.47 |
| 2, 5x5cm Bupivacaine Collagen Sponges | Pain Intensity VAS Scores Over Time at Rest | Hour 24 | 49.3 score on a scale | Standard Deviation 26.92 |
| 2, 5x5cm Bupivacaine Collagen Sponges | Pain Intensity VAS Scores Over Time at Rest | Hour 48 | 36.3 score on a scale | Standard Deviation 27.85 |
| 2, 5x5cm Bupivacaine Collagen Sponges | Pain Intensity VAS Scores Over Time at Rest | Hour 72 | 30.7 score on a scale | Standard Deviation 27.23 |
| 2, Placebo Collagen Sponges | Pain Intensity VAS Scores Over Time at Rest | Hour 24 | 51.5 score on a scale | Standard Deviation 26.65 |
| 2, Placebo Collagen Sponges | Pain Intensity VAS Scores Over Time at Rest | Hour 1 | 73.4 score on a scale | Standard Deviation 22.61 |
| 2, Placebo Collagen Sponges | Pain Intensity VAS Scores Over Time at Rest | Hour 10 | 52.0 score on a scale | Standard Deviation 30.41 |
| 2, Placebo Collagen Sponges | Pain Intensity VAS Scores Over Time at Rest | Hour 2 | 60.6 score on a scale | Standard Deviation 22.81 |
| 2, Placebo Collagen Sponges | Pain Intensity VAS Scores Over Time at Rest | Hour 72 | 38.3 score on a scale | Standard Deviation 30.16 |
| 2, Placebo Collagen Sponges | Pain Intensity VAS Scores Over Time at Rest | Hour 4 | 57.0 score on a scale | Standard Deviation 24.79 |
| 2, Placebo Collagen Sponges | Pain Intensity VAS Scores Over Time at Rest | Hour 12 | 55.2 score on a scale | Standard Deviation 29.72 |
| 2, Placebo Collagen Sponges | Pain Intensity VAS Scores Over Time at Rest | Hour 6 | 58.8 score on a scale | Standard Deviation 26.05 |
| 2, Placebo Collagen Sponges | Pain Intensity VAS Scores Over Time at Rest | Hour 48 | 47.2 score on a scale | Standard Deviation 29.78 |
| 2, Placebo Collagen Sponges | Pain Intensity VAS Scores Over Time at Rest | Hour 8 | 54.3 score on a scale | Standard Deviation 27.49 |
Secondary
Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough)
Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100). Patients were asked during multiple time points to provide a score on this VAS scale. The lower the sore the better the outcome. Higher score is a worse outcome
Time frame: 1,2,4,6,8,10,12,24,48 and 72 hours
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2, 5x5cm Bupivacaine Collagen Sponges | Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) | Hour 1 | 31.4 units on a scale | Standard Deviation 28.59 |
| 2, 5x5cm Bupivacaine Collagen Sponges | Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) | Hour 2 | 32.6 units on a scale | Standard Deviation 24.88 |
| 2, 5x5cm Bupivacaine Collagen Sponges | Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) | Hour 4 | 31.2 units on a scale | Standard Deviation 26.1 |
| 2, 5x5cm Bupivacaine Collagen Sponges | Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) | Hour 6 | 33.2 units on a scale | Standard Deviation 24.95 |
| 2, 5x5cm Bupivacaine Collagen Sponges | Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) | Hour 8 | 47.0 units on a scale | Standard Deviation 24.83 |
| 2, 5x5cm Bupivacaine Collagen Sponges | Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) | Hour 10 | 43.4 units on a scale | Standard Deviation 25.54 |
| 2, 5x5cm Bupivacaine Collagen Sponges | Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) | Hour 12 | 46.7 units on a scale | Standard Deviation 28.18 |
| 2, 5x5cm Bupivacaine Collagen Sponges | Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) | Hour 24 | 49.2 units on a scale | Standard Deviation 26.37 |
| 2, 5x5cm Bupivacaine Collagen Sponges | Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) | Hour 48 | 36.0 units on a scale | Standard Deviation 27.31 |
| 2, 5x5cm Bupivacaine Collagen Sponges | Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) | Hour 72 | 29.8 units on a scale | Standard Deviation 27 |
| 2, Placebo Collagen Sponges | Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) | Hour 24 | 51.5 units on a scale | Standard Deviation 26.65 |
| 2, Placebo Collagen Sponges | Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) | Hour 1 | 73.4 units on a scale | Standard Deviation 22.61 |
| 2, Placebo Collagen Sponges | Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) | Hour 10 | 52.0 units on a scale | Standard Deviation 30.41 |
| 2, Placebo Collagen Sponges | Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) | Hour 2 | 60.6 units on a scale | Standard Deviation 22.81 |
| 2, Placebo Collagen Sponges | Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) | Hour 72 | 38.3 units on a scale | Standard Deviation 30.16 |
| 2, Placebo Collagen Sponges | Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) | Hour 4 | 57.0 units on a scale | Standard Deviation 24.79 |
| 2, Placebo Collagen Sponges | Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) | Hour 12 | 28.18 units on a scale | Standard Deviation 29.72 |
| 2, Placebo Collagen Sponges | Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) | Hour 6 | 58.8 units on a scale | Standard Deviation 26.05 |
| 2, Placebo Collagen Sponges | Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) | Hour 48 | 47.2 units on a scale | Standard Deviation 29.78 |
| 2, Placebo Collagen Sponges | Pain Intensity Visual Analog Pain Scale Scores Over Time After Aggravated Movement (Cough) | Hour 8 | 54.3 units on a scale | Standard Deviation 27.49 |
Secondary
Sum of Pain Intensity (SPI) After Aggravated Movement (Cough)
Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100) at each time point. A lower score is better which means the patient experience lower pain. The score is calculated using the number of hours \* the VAS score. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. For each measure outcome - the minimum score is 0 and the maximum score is 100\* the number of hours in that period.
Time frame: 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.
Population: Intent-to-Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2, 5x5cm Bupivacaine Collagen Sponges | Sum of Pain Intensity (SPI) After Aggravated Movement (Cough) | 1 to 24 hours | 996.3 score on a scale*hour | Standard Deviation 503.65 |
| 2, 5x5cm Bupivacaine Collagen Sponges | Sum of Pain Intensity (SPI) After Aggravated Movement (Cough) | 25 to 48 hours | 1021.8 score on a scale*hour | Standard Deviation 604.71 |
| 2, 5x5cm Bupivacaine Collagen Sponges | Sum of Pain Intensity (SPI) After Aggravated Movement (Cough) | 1 to 48 hours | 2018.2 score on a scale*hour | Standard Deviation 1092.85 |
| 2, 5x5cm Bupivacaine Collagen Sponges | Sum of Pain Intensity (SPI) After Aggravated Movement (Cough) | 49 to 72 hours | 792.2 score on a scale*hour | Standard Deviation 633.88 |
| 2, Placebo Collagen Sponges | Sum of Pain Intensity (SPI) After Aggravated Movement (Cough) | 49 to 72 hours | 1027.4 score on a scale*hour | Standard Deviation 713.6 |
| 2, Placebo Collagen Sponges | Sum of Pain Intensity (SPI) After Aggravated Movement (Cough) | 1 to 24 hours | 1270.4 score on a scale*hour | Standard Deviation 566.52 |
| 2, Placebo Collagen Sponges | Sum of Pain Intensity (SPI) After Aggravated Movement (Cough) | 1 to 48 hours | 2457.2 score on a scale*hour | Standard Deviation 1155.63 |
| 2, Placebo Collagen Sponges | Sum of Pain Intensity (SPI) After Aggravated Movement (Cough) | 25 to 48 hours | 1186.7 score on a scale*hour | Standard Deviation 647.4 |
Secondary
Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest
Measured on a Visual Analog Pain Scale (VAS) with the lowest possible value of 0 and highest 100 (0 - 100) at each time point. A lower score is better which means the patient experience lower pain. The score is calculated using the number of hours \* the VAS score. This represents the AUC (Area Under the Curve) of the pain intensities when calculated with the trapezoidal rule. For each measure outcome - the minimum score is 0 and the maximum score is 100\* the number of hours in that period.
Time frame: 1, 2, 4, 6, 8, 10, 12, 24, 48, and 72 hours.
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2, 5x5cm Bupivacaine Collagen Sponges | Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest | 25 to 48 hours | 754.7 score on a scale*hour | Standard Deviation 538.41 |
| 2, 5x5cm Bupivacaine Collagen Sponges | Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest | 49 to 72 hours | 567.0 score on a scale*hour | Standard Deviation 565.64 |
| 2, 5x5cm Bupivacaine Collagen Sponges | Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest | 1 to 48 hours | 1496.4 score on a scale*hour | Standard Deviation 978.74 |
| 2, 5x5cm Bupivacaine Collagen Sponges | Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest | 1 to 72 hours | 2063.4 score on a scale*hour | Standard Deviation 1511.89 |
| 2, 5x5cm Bupivacaine Collagen Sponges | Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest | 1 to 24 hours | 741.6 score on a scale*hour | Standard Deviation 452.29 |
| 2, Placebo Collagen Sponges | Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest | 1 to 72 hours | 2035.0 score on a scale*hour | Standard Deviation 1271.12 |
| 2, Placebo Collagen Sponges | Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest | 1 to 24 hours | 856.6 score on a scale*hour | Standard Deviation 486.95 |
| 2, Placebo Collagen Sponges | Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest | 25 to 48 hours | 677.2 score on a scale*hour | Standard Deviation 455.96 |
| 2, Placebo Collagen Sponges | Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest | 1 to 48 hours | 1533.8 score on a scale*hour | Standard Deviation 875.52 |
| 2, Placebo Collagen Sponges | Sum of Pain Intensity (SPI) Using a Visual Analog Scale (VAS) When at Rest | 49 to 72 hours | 501.3 score on a scale*hour | Standard Deviation 451.92 |