DPNB for Prevention of CRDB

General Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01721031
• Other study ID #: DPNB120928
• Secondary ID: LRWCHA
• Status: Completed
• Phase: Phase 3
• Start date: April 1, 2013
• Est. completion date: December 15, 2015

Study information

• Verified date: September 2018
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 15, 2015
• Est. primary completion date: December 1, 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• General Anesthesia
• Indwelling Urinary Catheter
• Male Patients

Intervention

Procedure:
• DPNB
Patients receive DPNB 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.

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptance of indwelling urinary catheter		up to 6 months
Primary	Incidence and severity of CRBD		up to 6 months
Secondary	Visual analogue scale (VAS) for postoperative pain		up to 6 months
Secondary	Postoperative fentanyl requirement		up to 6 months
Secondary	Side effects	the level of sedation.; postoperative nausea vomiting (PONV); incidence of respiratory depression; incidence of agitation, and delirium	up to 6 months