Pain, PostoperativeSESPBNCT06127394
Efficacy of Sacral Erector Spinae Plane Block (SESPB) on Postoperative Pain and Catheter-related Bladder Discomfort
A study testing Sacral ESP Block and Pudendal Block in people with Pain, Postoperative, run by Giresun University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to evaluate the catheter related bladder discomfort in patients who will undergoing TUR-P operation. The main questions it aims to answer are: Is sacral ESPB effective on the pudendal nerve dermatome? Is sacral ESPB as useful as pudendal block on CRBD? Participants will be divided… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Sacral ESP Block and Pudendal Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Nov 2023to 15 Dec 2023
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologist (ASA) Physical status 1-3
Who cannot join
- American Society of Anesthesiologist (ASA) Physical status 4-5
- Refused to participate in the study
- Known allergy to local anaesthetic
- Where regional anaesthesia is contraindicated
- With known neurological, haematological or muscular disease
- Patients with infection or anatomical changes in the lumbo-sacral region
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Giresun Research and Training Hospital
Merkez, Giresun, 28100
About this study
Official title: Comparison of the Efficacy of Sacral Erector Spinae Plane Block (SESPB) and Pudendal Block on Postoperative Pain and Catheter-related Bladder Discomfort (CRBD) in Patients Undergoing Trans-urethral Resection of the Prostate (TUR-P).
The goal of this clinical trial is to evaluate the catheter related bladder discomfort in patients who will undergoing TUR-P operation. The main questions it aims to answer are:
- Is sacral ESPB effective on the pudendal nerve dermatome?
- Is sacral ESPB as useful as pudendal block on CRBD? Participants will be divided into two groups and the first group will receive sacral espb after TUR-p operation and the second group will receive pudendal block. Investigators will be present for 24 hours
- catheter related bladder discomfort
- post-operative pain,
- additional analgesic needs will be questioned and the difference between the two groups will be evaluated.
Read the detailed description
This is a prospective,randomised,double-blind, single-centre,study aiming to compare the effectiveness of US guided bilateral sacral ESPB and US guided bilateral pudendal block on CRBD and pain after TUR-P. 54 patients will be included in the study and divided into two groups. All patients will be standardly monitored and will receive general anaesthesia. At the end of the cases, sacral ESPB will be applied to the first group and pudendal block to the second group, and the patients and the data questioner physician will be blinded to the study.
Primary and secondary outcomes will be questioned for 24 hours and statistics will be made according to the result.
- Conditions
- Pain, Postoperative
- Being tested
- Sacral ESP Block, Pudendal Block
- Keywords
- regional block, pudendal block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral ESP BlockProcedure or surgery
Sacral ESPB median approach, 40 ml %0,25 Bupivacaine
Pudendal BlockProcedure or surgery
Bilateral pudendal block, 10 ml %0,25 bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| espb group | Experimental | Block will be performed with median technique at the level of sacral 2nd vertebrae. Receives: Procedure: Sacral ESP Block |
| pudendal group | Active comparator | Bilateral transperineal block will be performed Receives: Procedure: Pudendal Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter related bladder discomfort, 0:no discomfort 4:worst discomfort
It was evaluated with a 4-point scoring system developed and first used by Agarwall et al. . No symptoms: 0, Mild: mild discomfort that can be tolerated, Moderate: discomfort is present but not accompanied by behavioural reactions, Severe: discomfort is very severe and accompanied by body movements indicating that the patient cannot bear it.
Measured: baseline ,and 24 hours
Secondary outcomes (1)
Numerical Rating Scale,0 :no pain 10:worst pain
The NRS score of the patients was "0: no pain, 10: the most severe pain experienced". An NRS value of 4 and above indicates that the pain is severe and rescue analgesia is required.
Measured: baseline, and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start12 Nov 2023
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giresun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilge Olgun Keles, Giresun University
- Investigators
- Bilge Olgun Keleş, Principal investigator, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127394
- Sponsor's protocol ID
- 2023/07
- Acronym
- SESPB
- Status last verified
- May 2024
- First submitted
- 7 Nov 2023
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Sacral Erector Spinae Plane Block (SESPB) and Pudendal Block on Postoperative Pain and Catheter-related Bladder Discomfort (CRBD) in Patients Undergoing Trans-urethral Resection of the Prostate (TUR-P).
- ClinicalTrials.gov ID
- NCT06127394
- Acronym / sponsor ID
- SESPB / 2023/07
- Conditions
- Pain, Postoperative
- Keywords
- regional block, pudendal block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Giresun UniversityUniversity, hospital or other
- Study start
- 12 Nov 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 13 Nov 2023 (actual)
- 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 goal of this clinical trial is to evaluate the catheter related bladder discomfort in patients who will undergoing TUR-P operation. The main questions it aims to answer are:
- Is sacral ESPB effective on the pudendal nerve dermatome?
- Is sacral ESPB as useful as pudendal block on CRBD? Participants will be divided into two groups and the first group will receive sacral espb after TUR-p operation and the second group will receive pudendal block. Investigators will be present for 24 hours
- catheter related bladder discomfort
- post-operative pain,
- additional analgesic needs will be questioned and the difference between the two groups will be evaluated.
Detailed description
This is a prospective,randomised,double-blind, single-centre,study aiming to compare the effectiveness of US guided bilateral sacral ESPB and US guided bilateral pudendal block on CRBD and pain after TUR-P. 54 patients will be included in the study and divided into two groups. All patients will be standardly monitored and will receive general anaesthesia. At the end of the cases, sacral ESPB will be applied to the first group and pudendal block to the second group, and the patients and the data questioner physician will be blinded to the study.
Primary and secondary outcomes will be questioned for 24 hours and statistics will be made according to the result.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| espb group | Experimental | Procedure: Sacral ESP BlockBlock will be performed with median technique at the level of sacral 2nd vertebrae. |
| pudendal group | Active comparator | Procedure: Pudendal BlockBilateral transperineal block will be performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologist (ASA) Physical status 1-3
Key exclusion criteria (6 listed)
- American Society of Anesthesiologist (ASA) Physical status 4-5
- Refused to participate in the study
- Known allergy to local anaesthetic
- Where regional anaesthesia is contraindicated
- With known neurological, haematological or muscular disease
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 |
|---|---|---|
| Sacral ESP BlockSacral ESPB median approach, 40 ml %0,25 Bupivacaine | Procedure or surgery | espb group |
| Pudendal BlockBilateral pudendal block, 10 ml %0,25 bupivacaine | Procedure or surgery | pudendal group |
Primary outcome
Catheter related bladder discomfort, 0:no discomfort 4:worst discomfort
Time frame: baseline ,and 24 hours
It was evaluated with a 4-point scoring system developed and first used by Agarwall et al. . No symptoms: 0, Mild: mild discomfort that can be tolerated, Moderate: discomfort is present but not accompanied by behavioural reactions, Severe: discomfort is very severe and accompanied by body movements indicating that the patient cannot bear it.
1 secondary outcome
Numerical Rating Scale,0 :no pain 10:worst pain
Time frame: baseline, and 24 hours
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 17 May 2024.
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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.
Bilge Olgun Keleş principal investigator
Giresun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacral ESP Block and Pudendal Block in people with Pain, Postoperative, run by Giresun University 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 1 inclusion and 6 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 17 May 2024. 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?
Catheter related bladder discomfort, 0:no discomfort 4:worst discomfort (time frame: baseline ,and 24 hours). 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 17 May 2024.