Ultrasound Guided Pudendal Block in Transurethral Prostatectomies

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Diskapi Teaching and Research Hospital.
Recruitment status was  Recruiting
Sponsor:
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
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014