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DPNB for Prevention of CRDB

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01721031
Enrollment
58
Registered
2012-11-02
Start date
2013-04-01
Completion date
2015-12-15
Last updated
2018-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia, Indwelling Urinary Catheter, Male Patients

Keywords

Catheter Related Bladder Discomfort, Dorsal Penile Nerve Block

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.

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.

Interventions

PROCEDUREDPNB

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

DRUGTramadol

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

Sponsors

West China Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frame
Incidence and severity of CRBDup to 6 months

Secondary

MeasureTime frameDescription
Visual analogue scale (VAS) for postoperative painup to 6 months
Postoperative fentanyl requirementup to 6 months
Side effectsup to 6 months1. the level of sedation. 2. postoperative nausea vomiting (PONV) 3. incidence of respiratory depression 4. incidence of agitation, and delirium

Other

MeasureTime frame
Acceptance of indwelling urinary catheterup to 6 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026