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NCT Number: NCT01721031

DPNB for Prevention of CRDB

Catheter-related bladder discomfort (CRBD) secondary to an indwelling urinary catheter is defined as an urge to void or discomfort in the supra-pubic region. This symptom complex may cause patient agitated and exacerbated postoperative pain. In clinic, dorsal penile nerve block (DPNB) was applied for penile surgery including circumcision and some anterior urethra surgery. The investigators hypothesize that DPNB relive CRBD for male patients with indwelling urinary catheter under general anesthesia.

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Key information

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

About this study

CRBD is not uncommon in the postoperative period, especially in male patients who have had urinary catheterization after anesthetic induction under general anesthesia, and this symptom complex may cause patient agitated and exacerbated postoperative pain. According to the previous study, i.v. tramadol 1.5 mg/kg administered 30 min before extubation results in reduction in the incidence and severity of CRBD. In clinical practice, tramadol is associated with side effects including nausea, vomiting, sedation, etc. Clinically, dorsal penile nerve block (DPNB) was applied in penile surgery, and got satisfactory pain relief effect postoperatively without side effects related to tramadol. Besides, we observed patients underwent urethra surgery with urinary catheter left in situ seldom complained of CRBD if DPNB and RB performed at the end of operation. We hypothesized that DPNB could relieve DPNB for male patient with indwelling urinary catheter insertion after induction of general anesthesia.

In this study we compare the efficacy of dorsal penile nerve block (DPNB) with 0.33% ropivacaine and intravenous tramadol 1.5mg/kg in prevention of CRBD, as well as the incidences of side effects postoperatively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent signed
  • Male adult patient, aged 18~50 years old, ASA I~III
  • Surgery under general anesthesia

Exclusion criteria

  • Bladder dysfunction, such as overactive bladder
  • A history of bladder outflow obstruction
  • Prostate disease, such as benign prostate hyperplasia, etc.
  • Disturbance of central nervous system

Treatment and study plan

DPNB

Procedure

Patients receive DPNB 30min before extubation at the end of operation

Tramadol

Drug

Patients receive intravenous tramadol 1.5mg/kg 30min before extubation at the end of operation.

Primary outcomes

  1. Incidence and severity of CRBD

    Time frame: up to 6 months

Secondary outcomes

  1. Visual analogue scale (VAS) for postoperative pain

    Time frame: up to 6 months

  2. Postoperative fentanyl requirement

    Time frame: up to 6 months

  3. Side effects

    Time frame: up to 6 months

    • the level of sedation.
    • postoperative nausea vomiting (PONV)
    • incidence of respiratory depression
    • incidence of agitation, and delirium

Other outcomes

  1. Acceptance of indwelling urinary catheter

    Time frame: up to 6 months

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

Comparison of Dorsal Penile Nerve Block With 0.33% Ropivacaine and Intravenous Tramadol for Prevention of Catheter-related Bladder Discomfort: Study Protocol for a Randomized Controlled Trial

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 2, 2012
Registry last updated
Sep 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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