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

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Procedure: Pudendal Block; Procedure: Sacral ESP Block

• Registration Number: NCT06127394
• Lead Sponsor: Giresun University

Brief 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 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 Timeline

• Study First Submitted: 2023-11-07
• Study First Submitted QC: 2023-11-07
• Study Start: 2023-11-12
• Study First Posted: 2023-11-13
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pudendal group	Pudendal Block	Bilateral transperineal block will be performed
espb group	Sacral ESP Block	Block will be performed with median technique at the level of sacral 2nd vertebrae.

Primary Outcome Measures

Name	Time	Method
Catheter related bladder discomfort, 0:no discomfort 4:worst discomfort	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.

Secondary Outcome Measures

Name	Time	Method
Numerical Rating Scale,0 :no pain 10:worst pain	baseline, and 24 hours	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.

Trial Locations

Locations (1)

Giresun Research and Training Hospital; 🇹🇷 Merkez, Giresun, Turkey