DPNB for Prevention of CRDB
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
2 other identifiers
interventional
58
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2013
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2012
CompletedFirst Posted
Study publicly available on registry
November 2, 2012
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2015
CompletedSeptember 17, 2018
September 1, 2018
2.7 years
October 27, 2012
September 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence and severity of CRBD
up to 6 months
Secondary Outcomes (3)
Visual analogue scale (VAS) for postoperative pain
up to 6 months
Postoperative fentanyl requirement
up to 6 months
Side effects
up to 6 months
Other Outcomes (1)
Acceptance of indwelling urinary catheter
up to 6 months
Study Arms (2)
DPNB
EXPERIMENTALPatients receive DPNB 30min before extubation at the end of operation.
Tramadol
ACTIVE COMPARATORPatients receive intravenous tramadol 1.5mg/kg 30min before extubation at the end of operation.
Interventions
Eligibility Criteria
You may qualify if:
- Informed consent signed
- Male adult patient, aged 18\~50 years old, ASA I\~III
- Surgery under general anesthesia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Related Publications (2)
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.
PMID: 27082620DERIVEDLi 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.
PMID: 26715519DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor, Associate professor
Study Record Dates
First Submitted
October 27, 2012
First Posted
November 2, 2012
Study Start
April 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 15, 2015
Last Updated
September 17, 2018
Record last verified: 2018-09