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Completed

NCT Number: NCT06127394

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

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Giresun Research and Training Hospital

Merkez, Giresun, 28100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sacral ESP Block

Procedure

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

Pudendal Block

Procedure

Bilateral pudendal block, 10 ml %0,25 bupivacaine

Primary outcomes

  1. 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.

Secondary outcomes

  1. Numerical Rating Scale,0 :no pain 10:worst pain

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Giresun University

Other

Registry information

Official study 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).

Acronym: SESPB

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 13, 2023
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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