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

ABSTRACT: 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. 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.This 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.This 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.ClinicalTrials.gov identifier NCT02683070 . Registered on 11 February 2016.

SUBMITTER: Li JY

PROVIDER: S-EPMC5020438 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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

Li Jing-Yi JY Liao Ren R

Trials 20160913 1

<h4>Background</h4>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. 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.<h4>Methods/design</h4>This trial is ...[more]

PMID: 27618967

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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).

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

Publications

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

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