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Dorsal penile nerve block for rigid cystoscopy in men: study protocol for a randomized controlled trial.

ABSTRACT: Pain 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.The 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.This 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.ClinicalTrials.gov identifier NCT02502487 (6 Jul 2015).

SUBMITTER: Qiu Y

PROVIDER: S-EPMC4797248 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature

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Dorsal penile nerve block for rigid cystoscopy in men: study protocol for a randomized controlled trial.

Qiu Yan Y Hu An-Min AM Liu Jin J Du Gui-Zhi GZ

Trials 20160318 1

<h4>Background</h4>Pain 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, innerv ...[more]

PMID: 26988368

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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).

Project description:BackgroundWorldwide, one of the most common surgical procedures in the pediatric population is circumcision. There is no consent on the best anesthesiologic approach. This study aimed to investigate ultrasound-guided dorsal penile nerve block (DPNB) plus sedation in spontaneous breathing as a time-saving, safe, effective, and opioid-sparing technique.AimsThe primary outcome was the assessment of the time from the end of surgery and the discharge to the post-anesthesia care unit. Secondary outcomes were to evaluate the cumulative dosages of opioids, differences in pain levels between the two groups, and complications at the awakening, 4 h and 72 h after surgery, respectively.MethodsThis was a prospective study with a retrospective control group, approved by the Friuli-Venezia Giulia Ethics Committee. Children in the intervention group received an ultrasound-guided DPNB under sedation and spontaneous breathing. With the probe positioned transversally at the base of the penis using an in-plane approach with a modified technique, local anesthetic was injected under the deep fascia of the penis.ResultsWe recruited 70 children who underwent circumcision at the University Hospital of Udine, Italy, from 1 January 2016 to 1 October 2021: 35 children in the ultrasound-guided DPNB group and 35 children in the control group. Children who received ultrasound-guided DPNB had a statistically significant lower time to discharge from the operating room, did not require mechanical ventilation, maintained spontaneous breathing at all times, received fewer opioids, had lower mean intraoperative arterial pressures, and lower pain levels immediately after surgery.ConclusionUltrasound-guided DPNB associated with sedation and spontaneous breathing is a time-saving, opioid-sparing, safe, and effective strategy for the management of intraoperative and postoperative pain in children undergoing circumcision.Clinical trial registration: ClinicalTrial.gov (NCT04475458, 17 July 2020).

Project description:Hip fractures are very painful leading to lengthy hospital stays. Conventional methods of treating pain are limited. Non-steroidal anti-inflammatories are relatively contraindicated and opioids have significant side effects.Regional anaesthesia holds promise but results from these techniques are inconsistent. Trials to date have been inconclusive with regard to which blocks to use and for how long. Interpatient variability remains a problem.This is a single centre study conducted at Queen's Medical Centre, Nottingham; a large regional trauma centre in England. It is a pragmatic, parallel arm, randomized controlled trial. Sample size will be 150 participants (75 in each group). Randomization will be web-based, using computer generated concealed tables (service provided by Nottingham University Clinical Trials Unit). There is no blinding. Intervention will be a femoral nerve block (0.5 mls/kg 0.25% levo-bupivacaine) followed by ropivacaine (0.2% 5 ml/hr-1) infused via a femoral nerve catheter until 48 hours post-surgery. The control group will receive standard care. Participants will be aged over 70 years, cognitively intact (abbreviated mental score of seven or more), able to provide informed consent, and admitted directly through the Emergency Department from their place of residence. Primary outcomes will be cumulative ambulation score (from day 1 to 3 postoperatively) and cumulative dynamic pain scores (day 1 to 3 postoperatively). Secondary outcomes will be cumulative dynamic pain score preoperatively, cumulative side effects, cumulative calorific and protein intake, EUROQOL EQ-5D score, length of stay, and rehabilitation outcome (measured by mobility score).Many studies have shown the effectiveness of regional blockade in neck of femur fractures, but the techniques used have varied. This study aims to identify whether early and continuous femoral nerve block can be effective in relieving pain and enhancing mobilization.Trial registration.The trial is registered with the European clinical trials database Eudract ref: 2010-023871-25. (17/02/2011).ISRCTN92946117. Registered 26 October 2012.

Project description:BACKGROUND:The number of patients operated on for total knee arthroplasty (TKA) is growing worldwide. Outpatient surgery is defined by a length of stay (LOS) in the hospital of less than 12?h. This can be limited for TKA, with the efficient management of pain and perioperative complications, such as blood loss, affecting a safe hospital discharge. Outpatient TKA with a suitable protocol, including multimodal measures, could improve the success rate of this procedure. Among the main measures, single-shot sciatic nerve block in association with continuous femoral nerve block for pain control needs to be evaluated in outpatient TKA. Furthermore, to promote the safety of the postoperative period and to accelerate rehabilitation, patients who undergo ambulatory TKA could be discharged to a rehabilitation center on the day of surgery to screen adverse events and to optimize the rehabilitation process. This study is designed to assess the benefits of sciatic nerve block in postoperative pain relief for outpatient TKA. METHODS/DESIGN:This randomized prospective controlled study will be conducted in the knee unit of the teaching hospital of the Nice university and will include 40 patients undergoing primary unilateral outpatient TKA, discharged the day of surgery to a private rehabilitation center for enhanced recovery after surgery, after a hospital stay of less than 12?h. Before surgery, all patients will receive a continuous femoral nerve block with 2?mg/ml ropivacaine 20?ml, and then patients will be randomly assigned to receive or not receive a single-shot sciatic nerve block with 2?mg/ml ropivacaine, 20?ml. The primary outcome measure is the success rate of outpatient TKA. This rate is defined by patients discharged from the hospital to a rehabilitation center the day of surgery with no re-hospitalization due to insufficient pain control before the fifth postoperative day. Secondary outcomes include the incidence of major and minor adverse events during the first five postoperative days and measurement of the quality of recovery using the Knee injury and Osteoarthritis Outcome Score and the new International Knee Society scores plus the Quality of Recovery-40 questionnaire. DISCUSSION:The assessment of anesthesia and rehabilitation protocols enabling major orthopedic surgery, such as TKA, is necessary. This randomized controlled study will address the hypothesis that a suitable multimodal protocol including sciatic nerve block could improve pain control and thus improve the success rate of outpatient TKA. TRIAL REGISTRATION:EudraCT, 2016-000226-19. Registered on 15 April 2016.

Dataset Information

Dorsal penile nerve block for rigid cystoscopy in men: study protocol for a randomized controlled trial.

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Dorsal penile nerve block for rigid cystoscopy in men: study protocol for a randomized controlled trial.

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