Ultrasound Guided Pudendal Block in Transurethral Prostatectomies

NCT ID: NCT01501279

Last Updated: 2016-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-04-30

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

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)

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

pudendal nerve block

USG guided pudendal nerve block performed under general anesthesia

Group Type: EXPERIMENTAL

Pudendal nerve block

Intervention Type: PROCEDURE

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

no nerve block

Control group without nerve block

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pudendal nerve block

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

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Diskapi Teaching and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

derya özkan

consultant MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Derya Özkan, MD

Role: PRINCIPAL_INVESTIGATOR

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

Taylan Akkaya, MD

Role: STUDY_DIRECTOR

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

Nihat Karakoyunlu, MD

Role: STUDY_CHAIR

Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Urology Clinic

Julide Ergil, MD

Role: STUDY_CHAIR

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

Hamit Ersoy, MD

Role: STUDY_CHAIR

Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 3. Urology Clinic

Locations

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

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Diskapi2011

Identifier Type: -

Identifier Source: org_study_id