Clinical trial NCT01721031: DPNB for Prevention of CRDB
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Indwelling Urinary Catheter
Male Patients
General Anesthesia
Keywords: Catheter Related Bladder Discomfort
Dorsal Penile Nerve Block
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2012-11-02
Enrollment: 58
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Incidence and severity of CRBD
timeFrame: up to 6 months
Secondary outcomes:
measure: Visual analogue scale (VAS) for postoperative pain
timeFrame: up to 6 months
measure: Postoperative fentanyl requirement
timeFrame: up to 6 months
measure: Side effects
timeFrame: up to 6 months
Other outcomes:
measure: Acceptance of indwelling urinary catheter
timeFrame: up to 6 months
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
References:
citation: Li JY, Yi ML, Liao R. Dorsal Penile Nerve Block With Ropivacaine-Reduced Postoperative Catheter-Related Bladder Discomfort in Male Patients After Emergence of General Anesthesia: A Prospective, Randomized, Controlled Study. Medicine (Baltimore). 2016 Apr;95(15):e3409. doi: 10.1097/MD.0000000000003409.
citation: Li JY, Liao R. Dorsal penile nerve block with ropivacaine versus intravenous tramadol for the prevention of catheter-related bladder discomfort: study protocol for a randomized controlled trial. Trials. 2015 Dec 30;16:596. doi: 10.1186/s13063-015-1130-2.