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DPNB for Prevention of CRDB

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by West China Hospital
Information provided by (Responsible Party):
Ren Liao, West China Hospital Identifier:
First received: October 27, 2012
Last updated: October 7, 2015
Last verified: October 2015
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.

Condition Intervention Phase
Indwelling Urinary Catheter
Male Patients
General Anesthesia
Procedure: DPNB
Drug: Tramadol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by West China Hospital:

Primary Outcome Measures:
  • Incidence and severity of CRBD [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual analogue scale (VAS) for postoperative pain [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
  • Postoperative fentanyl requirement [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
  • Side effects [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
    1. the level of sedation.
    2. postoperative nausea vomiting (PONV)
    3. incidence of respiratory depression
    4. incidence of agitation, and delirium

Other Outcome Measures:
  • Acceptance of indwelling urinary catheter [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DPNB
Patients receive DPNB 30min before extubation at the end of operation.
Procedure: DPNB
Patients receive DPNB 30min before extubation at the end of operation
Active Comparator: Tramadol
Patients receive intravenous tramadol 1.5mg/kg 30min before extubation at the end of operation.
Drug: Tramadol
Patients receive intravenous tramadol 1.5mg/kg 30min before extubation at the end of operation.

Detailed Description:

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.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01721031

Contact: Ren Liao, M.D. +86-18980602177

China, Sichuan
West China Hospital, Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
Contact: Ren Liao, M.D.    +86-18980602177   
Principal Investigator: Ren Liao, M.D.         
Sponsors and Collaborators
West China Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ren Liao, Doctor, Associate professor, West China Hospital Identifier: NCT01721031     History of Changes
Other Study ID Numbers: DPNB120928  LRWCHA 
Study First Received: October 27, 2012
Last Updated: October 7, 2015
Health Authority: China: State Food and Drug Administration, P.R.China

Keywords provided by West China Hospital:
Catheter Related Bladder Discomfort
Dorsal Penile Nerve Block

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on October 21, 2016