Pain, PostoperativeNCT01501279
Ultrasound Guided Pudendal Block in Transurethral Prostatectomies
A study testing Pudendal nerve block in people with Pain, Postoperative, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Pudendal nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2011to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I,II,III status
- Who were scheduled to have elective transurethral resection of the prostate
Who cannot join
- Chronic renal failure
- coagulopathy
- active anorectal disease
- active urinary tract infection
- uncontrolled diabetes
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
Ankara, 06110
About this study
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
Read the 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
- Being tested
- Pudendal nerve block
- Keywords
- pudendal nerve block, postoperative pain, bladder spasm
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pudendal nerve blockProcedure or surgery
the pudendal nerve block is going to be performed to the medial of ischial tuberosity with USG guidance in lithotomy position
| Study group | Role | What they receive |
|---|---|---|
| pudendal nerve block | Experimental | USG guided pudendal nerve block performed under general anesthesia Receives: Procedure: Pudendal nerve block |
| no nerve block | No intervention | Control group without nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: postoperative 12 h
Secondary outcomes (1)
postoperative pain
VAS score (0-10)
Measured: postoperative 12 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, derya özkan, Diskapi Teaching and Research Hospital
- Investigators
- Derya Özkan, MD, Principal investigator, Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology ClinicTaylan Akkaya, MD, Study director, Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology ClinicNihat Karakoyunlu, MD, Study chair, Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Urology ClinicJulide Ergil, MD, Study chair, Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. AnesthesiologyClinicHamit Ersoy, MD, Study chair, Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 3. Urology Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501279
- Sponsor's protocol ID
- Diskapi2011
- Status last verified
- Dec 2011
- First submitted
- 20 Dec 2011
- Last updated
- 13 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Pudendal Block in Transurethral Prostatectomies
- ClinicalTrials.gov ID
- NCT01501279
- Acronym / sponsor ID
- Diskapi2011
- Conditions
- Pain, Postoperative
- Keywords
- pudendal nerve block, postoperative pain, bladder spasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 29 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pudendal nerve block | Experimental | Procedure: Pudendal nerve blockUSG guided pudendal nerve block performed under general anesthesia |
| no nerve block | No intervention | –Control group without nerve block |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I,II,III status
- Who were scheduled to have elective transurethral resection of the prostate
Key exclusion criteria (5 listed)
- Chronic renal failure
- coagulopathy
- active anorectal disease
- active urinary tract infection
- uncontrolled diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pudendal nerve blockthe pudendal nerve block is going to be performed to the medial of ischial tuberosity with USG guidance in lithotomy position | Procedure or surgery | pudendal nerve block |
Primary outcome
postoperative bladder spasm
Time frame: postoperative 12 h
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.
1 secondary outcome
postoperative pain
Time frame: postoperative 12 h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derya Özkan, MD principal investigator
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
Taylan Akkaya, MD study director
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital 1. Anesthesiology Clinic
Nihat Karakoyunlu, MD study chair
Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital Urology Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pudendal nerve block in people with Pain, Postoperative, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative bladder spasm (time frame: postoperative 12 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2016.