## Protocol Section
### Identification Module
**NCT ID:** NCT01501279

**Brief Title:** Ultrasound Guided Pudendal Block in Transurethral Prostatectomies

**Official Title:** Ultrasound Guided Pudendal Block in Transurethral Prostatectomies

#### Organization Study ID Info
**ID:** Diskapi2011
#### Organization
**Class:** OTHER
**Full Name:** Diskapi Teaching and Research Hospital
### Status Module
#### Completion Date
**Date:** 2013-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-06-13

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-06-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-04

**Type:** ACTUAL

#### Start Date
**Date:** 2011-12

**Status Verified Date:** 2011-12

#### Study First Post Date
**Date:** 2011-12-29
**Type:** ESTIMATED
**Study First Submit Date:** 2011-12-20
**Study First Submit QC Date:** 2011-12-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Diskapi Teaching and Research Hospital

#### Responsible Party

**Investigator Affiliation:** Diskapi Teaching and Research Hospital

**Investigator Full Name:** derya özkan

**Investigator Title:** consultant MD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Pain, Postoperative

**Keywords:**

- pudendal nerve block

- postoperative pain

- bladder spasm

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** USG guided pudendal nerve block performed under general anesthesia

**Intervention Names:**

- Procedure: Pudendal nerve block

**Label:** pudendal nerve block

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Control group without nerve block

**Label:** no nerve block

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- pudendal nerve block

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

**Name:** Pudendal nerve block

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** postoperative bladder spasm

**Time Frame:** postoperative 12 h

#### Secondary Outcomes

**Description:** VAS score (0-10)

**Measure:** postoperative pain

**Time Frame:** postoperative 12 h

### Eligibility Module

**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

**Maximum Age:** 80 Years

**Minimum Age:** 50 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ankara

**Country:** Turkey

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

**Zip:** 06110

#### Overall Officials

**Official 1:**

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

**Name:** Derya Özkan, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

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

**Name:** Taylan Akkaya, MD

**Role:** STUDY_DIRECTOR

**Official 3:**

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

**Name:** Nihat Karakoyunlu, MD

**Role:** STUDY_CHAIR

**Official 4:**

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

**Name:** Julide Ergil, MD

**Role:** STUDY_CHAIR

**Official 5:**

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

**Name:** Hamit Ersoy, MD

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC05

- Name: Musculoskeletal Diseases

### Condition Browse Module - Browse Leaves

- ID: M13069

- Name: Pain, Postoperative

- Relevance: HIGH

- As Found: Pain, Postoperative

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M15837

- Name: Spasm

- Relevance: LOW

- As Found: Unknown

- ID: M12077

- Name: Muscle Cramp

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010149

- Term: Pain, Postoperative

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
