Efficacy and safety of 0.75% ropivacaine instillation into subinguinal wound in patients after bilateral microsurgical varicocelectomy: a bi-center, randomized, double-blind, placebo-controlled trial

Abstract

Objective

To evaluate the efficacy and safety of 0.75% ropivacaine instillation into inguinal wound in patients who have undergone bilateral microsurgical varicocelectomy.

Patients and methods

Eighty-five men who were screened for bilateral varicoceles from March 2015 to July 2016 were randomized for the treatment. All patients underwent inguinal varicocelectomy by general anesthesia. After ligation of the internal spermatic veins from the spermatic cord, additional delivery of testis through inguinal incision site was done to ligate external spermatic veins and gubernacular veins. Before repairing external oblique aponeurosis, 6 mL of 0.75% ropivacaine and 6 mL of normal saline were instilled under the fascia and around the funiculus (spermatic cord) by a randomized and double-blind method. Visual analog scale (VAS) pain score and Prince Henry Pain Score (PHPS) were used for evaluating operative sites at 1, 2, 4, and 8 hours and 7 days after surgery. Safety and tolerability were evaluated throughout the course of this study by assessing adverse events.

Results

A total of 55 men completed the study. Of these 55 men, 31 received instillation of ropivacaine on the left operative site, while 24 received instillation of ropivacaine on the right operative site. VAS pain scores and PHPS in the ropivacaine-instilled operative site were significantly lower compared to those obtained with placebo at 2, 4, and 8 hours after surgery. In general, instillation of ropivacaine was safe and well tolerated in patients.

Conclusion

Ropivacaine instillation into inguinal surgical site wound significantly reduced postoperative pain after microsurgical varicocelectomy.

Keywords:

• pain
• ropivacaine
• microsurgical varicocelectomy

Acknowledgments

We thank the members of the Medical Device Clinical Trial Center of Chonbuk National University Hospital for helpful discussion. This study was supported by fund from the Biomedical Research Institute of Chonbuk National University Hospital, Jeonju, Republic of Korea. However, Biomedical Research Institute of Chonbuk National University Hospital had no role in study design, data collection, data management, data analysis, data interpretation, manuscript preparation, manuscript reviewing, or approval of this manuscript.

Disclosure

The authors report no conflicts of interest in this work.