Efficacy of Sacral Erector Spinae Plane Block (SESPB) on Postoperative Pain and Catheter-related Bladder Discomfort

Study Overview
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Brief Summary
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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
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This is a randomised, controlled, double-blind, single-centre, randomised, controlled, 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.

Official Title
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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).

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Procedure: Sacral ESP Block
* Procedure: Pudendal Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - American Society of Anesthesiologist (ASA) Physical status 1-3 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: espb group<br>Block will be performed with median technique at the level of sacral 2nd vertebrae. | Procedure: Sacral ESP Block<br>* Sacral ESPB median approach, 40 ml %0,25 Bupivacaine<br>|
| Active Comparator: pudendal group<br>Bilateral transperineal block will be performed | Procedure: Pudendal Block<br>* Bilateral pudendal block, 10 ml %0,25 bupivacaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline ,and 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline, and 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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regional block, pudendal block