Prevention of catheter-related bladder discomfort - pudendal nerve block with ropivacaine versus intravenous tramadol: study protocol for a randomized controlled trial.

Jing-Yi Li,Ren Liao

doi:10.1186/s13063-016-1575-y

Abstract

BackgroundCatheter-related bladder discomfort (CRBD) is a common distressing symptom complex during the postoperative period, especially after urologic procedures with a relatively greater size urinary catheter. In this study, we will enroll male patients undergoing elective prostate surgery with urinary catheterization under general anesthesia, and we will compare the efficacy of pudendal nerve block (PNB) and intravenous tramadol in CRBD prevention.Methods/designThis trial is a prospective, randomized controlled trial that will test the superiority of bilateral PNB with 0.33 % ropivacaine compared with intravenous tramadol 1.5 mg/kg for CRBD prevention. A total of 94 male patients undergoing elective prostate surgery with urinary catheterization after anesthesia induction will be randomized to receive either bilateral PNB with 0.33 % ropivacaine (the PNB group) or intravenous tramadol 1.5 mg/kg (the tramadol group) after the completion of surgery. The primary outcome is the incidence of CRBD. The most important secondary outcome is the severity of postoperative CRBD, and other secondary outcomes include Numeric Rating Scale (NRS) score for postoperative pain; incidence of postoperative side effects such as postoperative nausea/vomiting, sedation, dizziness, and dry mouth; postoperative requirement for tramadol as a rescue treatment for CRBD and sufentanil as a rescue analgesic for postoperative pain; and NRS score for acceptance of an indwelling urinary catheter.DiscussionThis trial is planned to test the superiority of PNB with 0.33 % ropivacaine compared with intravenous tramadol 1.5 mg/kg. It may provide a basis for a new clinical practice for the prevention of CRBD.Trial registrationClinicalTrials.gov identifier NCT02683070. Registered on 11 February 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1575-y) contains supplementary material, which is available to authorized users.

Highlights

Catheter-related bladder discomfort (CRBD) is a common distressing symptom complex during the postoperative period, especially after urologic procedures with a relatively greater size urinary catheter
This trial is planned to test the superiority of pudendal nerve block (PNB) with 0.33 % ropivacaine compared with intravenous tramadol 1.5 mg/kg
On the basis of the anatomical and physiological proof for nerve innervation, with the support of clinical experience, we designed this trial with the hypothesis that PNB has a CRBD-reductive effect with less side effects related to systemic administration of antimuscarinic agents than PNB with ropivacaine and intravenous tramadol, and we aim to provide a novel and effective way to reduce the incidence of CRBD and with a better outcome

Summary

Introduction

Catheter-related bladder discomfort (CRBD) is a common distressing symptom complex during the postoperative period, especially after urologic procedures with a relatively greater size urinary catheter. Catheter-related bladder discomfort (CRBD) in patients with urinary catheterization during operation is frequently reported in the postanesthesia care unit (PACU) [1]. It is a distressing symptom complex characterized as a burning sensation or stabbing pain with an urge to void or as discomfort from the suprapubic area to the urethra [2]. In spite of their beneficial effect on CRBD, systemic administration of these agents is associated with side effects such as nausea or vomiting, sedation, dizziness, or other unpleasant complications, which may result in reduced quality of recovery. It is important in clinical practice to establish an effective treatment for CRBD with reduced adverse effects

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