Ultrasound Guided Pudendal Block in Transurethral Prostatectomies

Pain, Postoperative Clinical Trial

Official title:

Ultrasound Guided Pudendal Block in Transurethral Prostatectomies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01501279
• Other study ID #: Diskapi2011
• Status: Completed
• Phase: N/A
• First received: December 20, 2011
• Last updated: June 10, 2016
• Start date: December 2011
• Est. completion date: April 2013

Study information

• Verified date: December 2011
• Source: Diskapi Teaching and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
Turkey	Ministry of health Diskapi Yildirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	postoperative 12 h	Yes
Secondary	postoperative pain	VAS score (0-10)	postoperative 12 h	Yes