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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Drug: Bupivacaine Collagen Sponge
Drug: Placebo Collagen Sponge
Unnamed facility
Bellaire, Texas, United States
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.
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.
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.
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
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Time frame: 1,2,4,6,8,10,12,24,48 and 72 hours
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
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