Dataset Information

Dorsal penile nerve block alleviates pain in men undergoing rigid cystoscopy: A single-center, randomized, double-blind, and placebo-controlled trial.

ABSTRACT:

Objective

To assess the effectiveness and safety of dorsal penile nerve block (DPNB) compared with tetracaine gel in analgesia for men undergoing rigid cystoscopy.

Patients and methods

This study was conducted as a prospective, randomized, double-blind, placebo-controlled, and single-center trial. Men undergoing diagnostic rigid cystoscopy were randomly allocated into one of three groups (n = 86 each): (1) tetracaine gel group (DPNB with saline), (2) DPNB group (DPNB with ropivacaine + plain lubricant), and (3) combination group (DPNB with ropivacaine + tetracaine gel). The primary outcome was visual analog scale (VAS) for pain at cystoscopic inspection of the external sphincter.

Results

VAS (median [interquartile]) at inspection of the external sphincter was significantly lower in both DPNB and combination groups than that in tetracaine gel group (4 [3-6] and 4 [3-5] vs 6 [5-7], P < .0001), with a 33% reduction of median VAS. Overall pain level during procedure was significantly alleviated in the DPNB and combination groups with more stabilized HR and MAP when compared with tetracaine gel group. No adverse events were observed during DPNB including penile hematoma, erection, local anesthetic toxicosis or incompletion of cystoscopy.

Conclusion

Our study suggests analgesia provided by DPNB with or without tetracaine gel instilled is superior to that provided by tetracaine gel alone in men undergoing diagnostic rigid cystoscopy.

Clinical trials registration

ClinicalTrials.gov registration number: NCT02502487.

SUBMITTER: Qiu Y

PROVIDER: S-EPMC8988839 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundPain is common in men undergoing rigid cystoscopy. Even with the application of a lubricant containing 2 % lidocaine, about 76 % of men suffer from mild to severe pain when undergoing rigid cystoscopy. The most painful part of the procedure for men is when the cystoscope passes through the membranous urethra. Song et al. (Neurourol Urodyn 29:592-5, 2010) did autopsies on males and found that the dorsal nerve of the penis (DNP), the terminal branch of the pudendal nerve, innervates the membranous urethra in 53.3 % of specimens. In addition, the urethral mucosa has branches of innervated DNP. Dorsal penile nerve block (DPNB) is usually used for circumcision in children, and it has been shown to provide effective analgesia for penile surgeries. In this study, we hypothesized that DPNB could reduce the overall pain level in men during rigid cystoscopy.Methods/designThe trial is a prospective, randomized, double-blind, placebo-controlled, single-center trial to evaluate the effectiveness and safety of DPNB in analgesia for men undergoing rigid cystoscopy. Participants will be enrolled and randomly allocated into one of three groups according to the different analgesia regimens: 1) tetracaine gel group (DPNB with saline), 2) DPNB group (DPNB with ropivacaine plus plain lubricant), 3) combination group (DPNB with ropivacaine plus tetracaine gel). The primary outcome of this study is the visual analog scale (VAS, 0-10) for pain at cystoscopic inspection of the external sphincter. VAS scores evaluated at other time points serve as secondary outcomes. Vital signs are secondary outcomes that address the discomfort and pain during the procedure. Furthermore, the incidence of adverse events as secondary outcomes will also be recorded for evaluation of the safety of DPNB in rigid cystoscopy. Clinical assessments will be evaluated prior to DPNB, at administration of the lubricant gel, at cystoscopic inspection of the penile and bulbar urethra, external sphincter, prostate, and bladder, as well as at withdrawal of the cystoscope.DiscussionThis research will determine the effectiveness and safety of DPNB in men undergoing rigid cystoscopy. The results of this trial may have important implications for exploring the role of DPNB in analgesia for cystoscopy in men.Trial registrationClinicalTrials.gov identifier NCT02502487 (6 Jul 2015).

Project description:Catheter-related bladder discomfort (CRBD) is a distressing symptom complex after surgery, especially in male patients who have had urinary catheterization under general anesthesia. In this prospective, randomized, controlled trial, we compared dorsal penile nerve block (DPNB) with 0.33% ropivacaine with intravenous tramadol 1.5?mg?kg(-1) in prevention of CRBD, as well as the incidences of postoperative side effects. Fifty-eight male patients aged 18 to 50 years, undergoing elective liver surgery and limb surgery with urinary catheterization, were enrolled and divided randomly into 2 groups. In the DPNB group, patients were given dorsal penile nerve block with 15?mL of 0.33% ropivacaine, and in the tramadol intravenous administration (TRAM) group, patients were given 1.5?mg?kg(-1) tramadol after the completion of surgery before extubation. The primary outcome was the incidence of CRBD, and the secondary outcomes included the severity of CRBD, postoperative side effects, postoperative pain, and the acceptance of urinary catheterization. Patients were evaluated upon arrival to postanesthetic care unit (PACU), at 0.5, 1, 2, 4, and 6?hours after patients' arrival in the PACU for outcomes. The incidence of CRBD was significantly lower in the DPNB group than in the TRAM group, either upon arrival to PACU (10.3% vs 37.9%, P?=?0.015), or at 0.5?hours (3.4% vs 34.5%, P?=?0.003), 1?hours (3.4% vs 37.9%, P?=?0.001), 2?hours (6.9% vs 34.5%, P?=?0.010), and 4?hours (6.9% vs 27.6%, P?=?0.039) after patients' arrival in PACU. Compared with the TRAM group, the severity of postoperative CRBD upon arrival to PACU (P?=?0.011) and at 0.5?hours (P?=?0.005), 1?hours (P?=?0.002), 2?hours (P?=?0.005), 4?hours (P?=?0.017), and 6?hours (P?=?0.047) after patients' arrival in PACU were all significantly reduced in the DPNB group. The incidences of postoperative nausea, vomiting, dizziness, and sedation were decreased significantly in the DPNB group compared with the TRAM group (P?<?0.05). The acceptance of urinary catheterization was 93.1% (27/29 patients) in the DPNB group and 58.6% (17/29 patients) in the TRAM group, respectively (P?<?0.001).DPNB with ropivacaine has a better effect for CRBD reduction and less side effects than intravenous tramadol administration. The trial has been registered at www.clinicaltrials.gov (NCT01721031).

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