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DPNB for Prevention of CRDB

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ClinicalTrials.gov Identifier: NCT01721031
Recruitment Status : Unknown
Verified October 2015 by Ren Liao, West China Hospital.
Recruitment status was:  Recruiting
First Posted : November 2, 2012
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Ren Liao, West China Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Indwelling Urinary Catheter Male Patients General Anesthesia Procedure: DPNB Drug: Tramadol Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2012
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Incidence and severity of CRBD [ Time Frame: up to 6 months ]

Secondary Outcome Measures :
  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 ]
    1. the level of sedation.
    2. postoperative nausea vomiting (PONV)
    3. incidence of respiratory depression
    4. incidence of agitation, and delirium


Other Outcome Measures:
  1. Acceptance of indwelling urinary catheter [ Time Frame: up to 6 months ]


Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01721031


Contacts
Contact: Ren Liao, M.D. +86-18980602177 liaoren7733@163.com

Locations
China, Sichuan
West China Hospital, Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
Contact: Ren Liao, M.D.    +86-18980602177    liaoren7733@163.com   
Principal Investigator: Ren Liao, M.D.         
Sponsors and Collaborators
West China Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ren Liao, Doctor, Associate professor, West China Hospital
ClinicalTrials.gov Identifier: NCT01721031     History of Changes
Other Study ID Numbers: DPNB120928
LRWCHA ( Other Identifier: WestChinaH )
First Posted: November 2, 2012    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015

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

Additional relevant MeSH terms:
Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents