DPNB for Prevention of CRDB

Sichuan University

Status and phase: Completed; Phase 3

Conditions: Indwelling Urinary Catheter; General Anesthesia; Male Patients

Treatments: Procedure: DPNB; Drug: Tramadol

Study type: Interventional

Funder types: Other

Identifiers

NCT01721031

LRWCHA (Other Identifier)

DPNB120928

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

DPNB

Experimental group

Description:

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

Treatment:

Procedure: DPNB

Tramadol

Active Comparator group

Description:

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

Treatment:

Drug: Tramadol