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

Pain, Postoperative Clinical Trial

— SESPB  

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06127394
• Other study ID #: 2023/07
• Status: Completed
• Phase: N/A
• Start date: November 12, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: May 2024
• Source: Giresun University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• Sacral ESP Block
Sacral ESPB median approach, 40 ml %0,25 Bupivacaine
• Pudendal Block
Bilateral pudendal block, 10 ml %0,25 bupivacaine

Locations

Country	Name	City	State
Turkey	Giresun Research and Training Hospital	Merkez	Giresun

Sponsors (1)

Lead Sponsor	Collaborator
Giresun University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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