DPNB for Prevention of CRDB | NCT01721031

Studies
DPNB for Prevention of CRDB

NCT01721031

Sponsor

West China Hospital

Status

Completed

Last Update Posted

Sep 17, 2018Actual

Enrollment

58Actual

Phase

Phase 3

Conditions

Indwelling Urinary Catheter
Male Patients
General Anesthesia

Interventions

DPNB
Tramadol

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
LRWCHA	Other Identifier	WestChinaH

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2013Actual

Primary Completion Date

Dec 1, 2015Actual

Completion Date

Dec 15, 2015Actual

First Submitted Date

Oct 27, 2012

First Submission Date that Met QC Criteria

Nov 1, 2012

First Posted Date

Nov 2, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2018

Last Update Posted Date

Sep 17, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ren Liao, Doctor, Associate professor, West China HospitalPrincipal Investigator

Lead Sponsor

West China HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DPNB	Experimental	Patients receive DPNB 30min before extubation at the end of operation.	Procedure: DPNB
Tramadol	Active Comparator	Patients receive intravenous tramadol 1.5mg/kg 30min before extubation at the end of operation.	Drug: Tramadol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DPNB	Procedure	Patients receive DPNB 30min before extubation at the end of operation	DPNB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence and severity of CRBD		up to 6 months

Secondary Outcomes

Measure	Description	Time Frame
Visual analogue scale (VAS) for postoperative pain		up to 6 months
Postoperative fentanyl requirement		up to 6 months
Side effects

Other Outcomes

Measure	Description	Time Frame
Acceptance of indwelling urinary catheter		up to 6 months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
West China Hospital, Sichuan University		Chengdu	Sichuan	610041	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27082620	Derived	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.
26715519	Derived

ID	Term
D003511	Cyclohexanols
D000441	Hexanols
D005233	Fatty Alcohols
D000438	Alcohols
D009930