DPNB for Prevention of CRDB

Phase 3

Completed

• Conditions: Indwelling Urinary Catheter; Male Patients; General Anesthesia
• Interventions: Drug: Tramadol; Procedure: DPNB

• Registration Number: NCT01721031
• Lead Sponsor: West China Hospital

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.

Study Timeline

• Study First Submitted: 2012-10-27
• Study First Submitted QC: 2012-11-01
• Study First Posted: 2012-11-02
• Study Start: 2013-04-01
• Primary Completion: 2015-12-01
• Study Completion: 2015-12-15
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tramadol	Tramadol	Patients receive intravenous tramadol 1.5mg/kg 30min before extubation at the end of operation.
DPNB	DPNB	Patients receive DPNB 30min before extubation at the end of operation.

Primary Outcome Measures

Name	Time	Method
Incidence and severity of CRBD	up to 6 months

Secondary Outcome Measures

Name	Time	Method
Visual analogue scale (VAS) for postoperative pain	up to 6 months
Postoperative fentanyl requirement	up to 6 months
Side effects	up to 6 months	1. the level of sedation.; 2. postoperative nausea vomiting (PONV); 3. incidence of respiratory depression; 4. incidence of agitation, and delirium

Trial Locations

Locations (1)

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China