DPNB for Prevention of CRDB

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ren Liao, West China Hospital
ClinicalTrials.gov Identifier:
NCT01721031
First received: October 27, 2012
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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) plus ring block (RB) was applied for penile surgery including circumcision and some anterior urethra surgery. The investigators hypothesize that DPNB plus RB relive CRBD for male patients with indwelling urinary catheter under general anesthesia.


Condition Intervention Phase
Indwelling Urinary Catheter
Male Patients
General Anesthesia
Procedure: DPNB plus RB
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 Plus Ring Block With 0.33% Ropivacaine and Intravenous Tramadol for Prevention of Catheter-related Bladder Discomfort

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 (April 1,2013) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual analogue scale (VAS) for postoperative pain [ Time Frame: up to 6 months (April 1, 2013) ] [ Designated as safety issue: No ]
  • Postoperative fentanyl requirement [ Time Frame: up to 6 months (April 1, 2013) ] [ Designated as safety issue: No ]
  • Side effects [ Time Frame: up to 6 months (April 1, 2013) ] [ 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 (April 1, 2013) ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: October 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DPNB
Patients receive DPNB plus RB 30min before extubation at the end of operation.
Procedure: DPNB plus RB
Patients receive DPNB plus RB 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) plus ring block (RB) 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 plus RB 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) plus ring block (RB) with 0.33% ropivacaine and intravenous tramadol 1.5mg/kg in prevention of CRBD, as well as the incidences of side effects postoperatively.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01721031

Locations
China, Sichuan
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
West China Hospital
  More Information

No publications provided

Responsible Party: Ren Liao, Doctor, Associate professor, West China Hospital
ClinicalTrials.gov Identifier: NCT01721031     History of Changes
Other Study ID Numbers: DPNB120928, LRWCHA
Study First Received: October 27, 2012
Last Updated: February 12, 2014
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:
Tramadol
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid

ClinicalTrials.gov processed this record on July 24, 2014