Ultrasound Guided Pudendal Block in Transurethral Prostatectomies

NCT01501279 | Completed DMC

• 1 other identifier: Diskapi2011
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Pain, Postoperative

Keywords

pudendal nerve block; postoperative pain; bladder spasm

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• postoperative pain

  postoperative 12 h

Study Arms (2)

pudendal nerve block

EXPERIMENTAL

USG guided pudendal nerve block performed under general anesthesia

Procedure: Pudendal nerve block

no nerve block

NO INTERVENTION

Control group without nerve block

Interventions

Pudendal nerve block PROCEDURE

the pudendal nerve block is going to be performed to the medial of ischial tuberosity with USG guidance in lithotomy position

pudendal nerve block

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I,II,III status
• Who were scheduled to have elective transurethral resection of the prostate

You may not qualify if:

• Chronic renal failure
• coagulopathy
• active anorectal disease
• active urinary tract infection
• uncontrolled diabetes

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic

Ankara, 06110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Derya Özkan, MD

  Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic

  PRINCIPAL INVESTIGATOR

• Taylan Akkaya, MD

  Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: consultant MD

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 29, 2011
• Study Start: December 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: June 13, 2016

Record last verified: 2011-12

Locations

TU (1)