Efficacy and Safety of A Collagen Bupivacaine Implant in Women Following Abdominal Hysterectomy
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|ClinicalTrials.gov Identifier: NCT00624910|
Recruitment Status : Completed
First Posted : February 28, 2008
Last Update Posted : March 23, 2012
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Drug: Bupivacaine Collagen Sponge (CollaRx®) Drug: placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Phase II, Single Dose, Blinded, Prospective Study to Investigate the Efficacy and Safety of the CollaRx® Bupivacaine Implant in Women Following Abdominal Hysterectomy or Other Nonlaparoscopic Benign Gynecological Procedure|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure
Drug: 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.
Other Name: CollRx Bupivacaine Implant
Placebo Comparator: 2
A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure
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.
No Intervention: 3
The patient will recieve the standard of care, but no implant during surgery
- Total use of opioid rescue analgesia [ Time Frame: 0 to 24 hours postoperatively ]
- Total use of opioid rescue analgesia [ Time Frame: 0 to 48 hours postoperatively ]
- Total use of opioid rescue analgesia [ Time Frame: 0 to 72 hours postoperatively ]
- Pain intensity rating on a Visual Analog Scale [ Time Frame: 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 [ Time Frame: At 1, 1.5, 2, 3, 6, 9, 12, 18, 24, 36, 48 and 72 hours postoperatively ]
- Time to first use of opioid rescue analgesia [ Time Frame: Actual time assessed during post operative period ]
- Treatment emergent adverse events [ Time Frame: 0-72 hours postoperatively ]
- Vital signs - heart rate, respiration rate, systolic and diastolic blood pressure and body temperature [ Time Frame: 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 18, 24, 36, 48 and 72 hours postoperatively ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00624910
|United States, North Carolina|
|Forsyth Medical Centre - OB Anesthesia|
|Winston Salem, North Carolina, United States, 27103|
|Study Director:||David Prior||Innocoll|