Ultrasound Guided Pudendal Block in Transurethral Prostatectomies
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pudendal nerve block
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Postoperative focused on measuring pudendal nerve block, postoperative pain, bladder spasm
Eligibility Criteria
Inclusion Criteria:
- ASA I,II,III status
- Who were scheduled to have elective transurethral resection of the prostate
Exclusion Criteria:
- Chronic renal failure
- coagulopathy
- active anorectal disease
- active urinary tract infection
- uncontrolled diabetes
Sites / Locations
- Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
pudendal nerve block
no nerve block
Arm Description
USG guided pudendal nerve block performed under general anesthesia
Control group without nerve block
Outcomes
Primary Outcome Measures
postoperative bladder spasm
Postoperative bladder spasm (Severity of bladder discomfort will record as severe(behavioral responses such as strong vocal response, flailing limbs),moderate (not accompanied by any behavioral responses) and no bladder discomfort.
Secondary Outcome Measures
postoperative pain
VAS score (0-10)
Full Information
NCT ID
NCT01501279
First Posted
December 20, 2011
Last Updated
June 10, 2016
Sponsor
Diskapi Teaching and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01501279
Brief Title
Ultrasound Guided Pudendal Block in Transurethral Prostatectomies
Official Title
Ultrasound Guided Pudendal Block in Transurethral Prostatectomies
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The pudendal nerve conveys sensory, motor, sympathetic fibres to the perineum, bladder neck and proximal urethra. Pain management during transurethral procedures is a major concern.Patients who have been catheterized under anesthesia complained of urgency in the postoperative period because of catheter-related bladder irritation. We want to investigate that the effect of pudendal block to postoperative pain, bladder spasm and patient comfort in transurethral prostatectomies
Detailed Description
Outcome measures USG guided transperineal pudendal block success Postoperative pain score (VAS score) Postoperative bladder spasm (Severity of bladder discomfort will record as severe(behavioral responses such as strong vocal response, flailing limbs),moderate (not accompanied by any behavioral responses) and no bladder discomfort.
Postoperative patient's comfort (poor, sufficient, good)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
pudendal nerve block, postoperative pain, bladder spasm
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pudendal nerve block
Arm Type
Experimental
Arm Description
USG guided pudendal nerve block performed under general anesthesia
Arm Title
no nerve block
Arm Type
No Intervention
Arm Description
Control group without nerve block
Intervention Type
Procedure
Intervention Name(s)
Pudendal nerve block
Intervention Description
the pudendal nerve block is going to be performed to the medial of ischial tuberosity with USG guidance in lithotomy position
Primary Outcome Measure Information:
Title
postoperative bladder spasm
Description
Postoperative bladder spasm (Severity of bladder discomfort will record as severe(behavioral responses such as strong vocal response, flailing limbs),moderate (not accompanied by any behavioral responses) and no bladder discomfort.
Time Frame
postoperative 12 h
Secondary Outcome Measure Information:
Title
postoperative pain
Description
VAS score (0-10)
Time Frame
postoperative 12 h
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA I,II,III status
Who were scheduled to have elective transurethral resection of the prostate
Exclusion Criteria:
Chronic renal failure
coagulopathy
active anorectal disease
active urinary tract infection
uncontrolled diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derya Özkan, MD
Organizational Affiliation
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Taylan Akkaya, MD
Organizational Affiliation
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nihat Karakoyunlu, MD
Organizational Affiliation
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Urology Clinic
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Julide Ergil, MD
Organizational Affiliation
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. AnesthesiologyClinic
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hamit Ersoy, MD
Organizational Affiliation
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 3. Urology Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
City
Ankara
ZIP/Postal Code
06110
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Ultrasound Guided Pudendal Block in Transurethral Prostatectomies
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