DPNB for Prevention of CRDB

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-01

Study Completion Date

2015-12-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Indwelling Urinary Catheter Male Patients General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DPNB

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

Group Type EXPERIMENTAL

DPNB

Intervention Type PROCEDURE

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

Tramadol

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

Group Type ACTIVE_COMPARATOR

Tramadol

Intervention Type DRUG

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

Interventions

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DPNB

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

Intervention Type PROCEDURE

Tramadol

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No