Ultrasound Guided Pudendal Block in Transurethral Prostatectomies
This study is currently recruiting participants.
Verified December 2011 by Diskapi Teaching and Research Hospital
Sponsor:
Diskapi Teaching and Research Hospital
Information provided by (Responsible Party):
derya özkan, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier:
NCT01501279
First received: December 20, 2011
Last updated: December 28, 2011
Last verified: December 2011
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Purpose
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
| Condition | Intervention |
|---|---|
|
Pain, Postoperative |
Procedure: Pudendal nerve block |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Ultrasound Guided Pudendal Block in Transurethral Prostatectomies |
Further study details as provided by Diskapi Teaching and Research Hospital:
Primary Outcome Measures:
- postoperative bladder spasm [ Time Frame: postoperative 12 h ] [ Designated as safety issue: Yes ]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 [ Time Frame: postoperative 12 h ] [ Designated as safety issue: Yes ]VAS score (0-10)
| Estimated Enrollment: | 40 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: pudendal nerve block
USG guided pudendal nerve block performed under general anesthesia
|
Procedure: Pudendal nerve block
the pudendal nerve block is going to be performed to the medial of ischial tuberosity with USG guidance in lithotomy position
|
|
No Intervention: no nerve block
Control group without nerve block
|
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)
Eligibility| Ages Eligible for Study: | 50 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501279
Locations
| Turkey | |
| Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic | Recruiting |
| Ankara, Turkey, 06110 | |
| Contact: Derya Özkan, MD +903125962553 derya_z@yahoo.com | |
| Principal Investigator: Derya Özkan, MD | |
Sponsors and Collaborators
Diskapi Teaching and Research Hospital
Investigators
| Principal Investigator: | Derya Özkan, MD | Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic |
| Study Director: | Taylan Akkaya, MD | Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic |
| Study Chair: | Julide Ergil, MD | Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic |
| Study Chair: | Nihat Karakoyunlu, MD | Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 3. Urology Clinic |
| Study Chair: | Hamit Ersoy, MD | Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 3. Urology Clinic |
More Information
No publications provided
| Responsible Party: | derya özkan, consultant MD, Diskapi Teaching and Research Hospital |
| ClinicalTrials.gov Identifier: | NCT01501279 History of Changes |
| Other Study ID Numbers: | Diskapi2011 |
| Study First Received: | December 20, 2011 |
| Last Updated: | December 28, 2011 |
| Health Authority: | Turkey: Ethics Committee |
Keywords provided by Diskapi Teaching and Research Hospital:
|
pudendal nerve block postoperative pain bladder spasm |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013