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

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).

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Procedure: Sacral ESP Block; Procedure: Pudendal Block

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Giresun
    • Merkez, Giresun, Turkey, 28100
      • Giresun Research and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Giresun University
• Investigators: Principal Investigator: Bilge Olgun Keleş, Giresun University

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2023
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: November 7, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: regional block; pudendal block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2023/07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No