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

NCT ID: NCT06127394

Last Updated: 2024-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-12

Study Completion Date

2023-12-15

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 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

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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espb group

Block will be performed with median technique at the level of sacral 2nd vertebrae.

Group Type EXPERIMENTAL

Sacral ESP Block

Intervention Type PROCEDURE

Sacral ESPB median approach, 40 ml %0,25 Bupivacaine

pudendal group

Bilateral transperineal block will be performed

Group Type ACTIVE_COMPARATOR

Pudendal Block

Intervention Type PROCEDURE

Bilateral pudendal block, 10 ml %0,25 bupivacaine

Interventions

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Sacral ESP Block

Sacral ESPB median approach, 40 ml %0,25 Bupivacaine

Intervention Type PROCEDURE

Pudendal Block

Bilateral pudendal block, 10 ml %0,25 bupivacaine

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Giresun University

OTHER

Sponsor Role lead

Responsible Party

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Bilge Olgun Keles

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bilge Olgun Keleş

Role: PRINCIPAL_INVESTIGATOR

Giresun University

Locations

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Giresun Research and Training Hospital

Merkez, Giresun, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2023/07

Identifier Type: -

Identifier Source: org_study_id

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