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Ultrasound Guided Pudendal Block in Transurethral Prostatectomies

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01501279
First Posted: December 29, 2011
Last Update Posted: June 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
derya özkan, Diskapi Teaching and Research Hospital
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Ultrasound Guided Pudendal Block in Transurethral Prostatectomies

Further study details as provided by derya özkan, Diskapi Teaching and Research Hospital:

Primary Outcome Measures:
  • postoperative bladder spasm [ Time Frame: postoperative 12 h ]
    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 ]
    VAS score (0-10)


Enrollment: 40
Study Start Date: December 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01501279


Locations
Turkey
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
Ankara, Turkey, 06110
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: Nihat Karakoyunlu, MD Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Urology Clinic
Study Chair: Julide Ergil, MD Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. AnesthesiologyClinic
Study Chair: Hamit Ersoy, MD Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 3. Urology Clinic
  More Information

Responsible Party: derya özkan, consultant MD, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier: NCT01501279     History of Changes
Other Study ID Numbers: Diskapi2011
First Submitted: December 20, 2011
First Posted: December 29, 2011
Last Update Posted: June 13, 2016
Last Verified: December 2011

Keywords provided by derya özkan, Diskapi Teaching and Research Hospital:
pudendal nerve block
postoperative pain
bladder spasm

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms