CPL-01, an investigational long-acting ropivacaine, demonstrates safety and efficacy in open inguinal hernia repair.

BACKGROUND: There is an unmet medical need for effective nonopioid analgesics that can decrease pain while reducing systemic opioid use. CPL-01, an extended-release injectable formulation of ropivacaine, is designed to safely provide analgesia and reduce or eliminate opioid use in the postoperative period. METHODS: Subjects undergoing open inguinal hernia with mesh were prospectively randomized to 1 of 3 doses of CPL-01 (10, 20, or 30 ml of 2% CPL-01, n = 14, 12, and 14, respectively), Naropin (150 mg, n = 40), or saline placebo (n = 13) infiltrated into the surgical site prior to closure. Pain and rescue medication usage was assessed, and Numeric Rating Scale (NRS) pain scores were adjusted for opioid usage using windowed worst observation carried forward (wWOCF) imputation. The primary efficacy endpoint was the mean area under the curve (AUC) of the NRS pain intensity scores with activity. RESULTS: Ninety-three subjects were treated, and 91 subjects completed 72 h of post-operative monitoring. Subjects who received the highest dose of CPL-01 in Cohort 3 showed a clinically meaningful reduction in postoperative pain intensity scores, which was the lowest value for any treatment in all cohorts, showing a trend towards statistical significance as compared to the pooled placebo group (p = 0.08), and numerically better than the 40 subjects who received Naropin. Opioid use through 72 h in subjects who received CPL-01 in Cohort 3 was approximately half of that shown in the placebo and Naropin groups; approximately 2/3 of the CPL-01 subjects (9/14) required no opioids at all through the first 72 h after the operation. More CPL-01 subjects avoided severe pain and were ready for discharge earlier than other groups. CPL-01 was safe and well-tolerated, with no clinically meaningful safety signals, and showed predictable and consistent extended-release pharmacokinetics. CONCLUSION: Results suggest that CPL-01 may be the first long-acting ropivacaine to address postoperative pain while reducing the need for opioids.

An infrared ureteral stent to aid in laparoscopic retroperitoneal lymph node dissection.

PURPOSE: We used an infrared ureteral stent to aid in laparoscopic retroperitoneal lymph node dissection. MATERIALS AND METHODS: The patient was slender 31-year-old male. An infrared light emitting stent was used. RESULTS: With easy visualization of the ureter laparoscopic retroperineal lymph node dissection required 268 minutes. CONCLUSIONS: The infrared ureteral stent decreases the operative time of laparoscopic retroperitoneal lymph node dissection and makes it a safer and more acceptable treatment option.

Assessment of the feasibility and impact of shared decision making in prostate cancer.

OBJECTIVES: To assess the feasibility and patient impact of using standardized video presentations concerning alternative treatments for managing localized prostate cancer. METHODS: One hundred eleven men with newly diagnosed localized prostate cancer were shown a video tape concerning the risks and benefits of four treatment options: radical surgery, external beam radiation, hormonal therapy, and watchful waiting. The impact of the video presentation was assessed using a questionnaire completed by the patient before and after viewing the video and again following a discussion with his treating physician. RESULTS: Patients demonstrated significant increases in their understanding of treatment options to manage prostate cancer after viewing the video presentation. Treating physicians confirmed the increased sophistication of their patients' knowledge of their disease and the potential outcomes associated with alternative treatments. CONCLUSIONS: Standardized video presentations of treatment alternatives for prostate cancer can be incorporated into busy office practices. Both patients and physicians benefit from the increased level of understanding that allows physician/patient discussions to focus on the critical risk/benefit tradeoffs rather than simply describing treatment alternatives.

The prevalence of cystic abnormalities of the prostate involving the ejaculatory ducts as detected by transrectal ultrasound.

PURPOSE: To determine the prevalence of cystic lesions of the prostate involving the ejaculatory ducts using transrectal ultrasound (TRUS). MATERIALS AND METHODS: The prevalence of cystic lesions of the prostate involving the ejaculatory ducts was determined in a prostate cancer screening group and also in an "at risk" population of men with infertility. RESULTS: Cystic lesions of the prostate involving the ejaculatory ducts as detected by TRUS were detected in 5.0% (20 of 400 consecutive men) in a prostate cancer screening population. In contrast, these abnormalities were present in 17.0% (23/135) of the "at risk" infertile men who had TRUS performed. CONCLUSIONS: This is the largest series to date defining the prevalence of TRUS-identified cystic lesions of the prostate in a non-infertility population. While cystic lesions of the prostate involving the ejaculatory duct are uncommon in an otherwise healthy and fertile male, their prevalence increases in infertile men whose examination and semen analyses make them "at risk" for having ductal obstruction.