Viewing Study NCT01721031



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Last Modification Date: 2024-10-26 @ 10:58 AM
Study NCT ID: NCT01721031
Status: COMPLETED
Last Update Posted: 2018-09-17
First Post: 2012-10-27

Brief Title: DPNB for Prevention of CRDB
Sponsor: West China Hospital
Organization: West China Hospital

Study Overview

Official Title: Comparison of Dorsal Penile Nerve Block With 033 Ropivacaine and Intravenous Tramadol for Prevention of Catheter-related Bladder Discomfort Study Protocol for a Randomized Controlled Trial
Status: COMPLETED
Status Verified Date: 2018-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 iv tramadol 15 mgkg 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 033 ropivacaine and intravenous tramadol 15mgkg in prevention of CRBD as well as the incidences of side effects postoperatively

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
LRWCHA OTHER WestChinaH None