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

NCT06127394 | Completed DMC

• 1 other identifier: 2023/07
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

regional block; pudendal block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Numerical Rating Scale,0 :no pain 10:worst pain

  baseline, and 24 hours

Study Arms (2)

espb group

EXPERIMENTAL

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

Procedure: Sacral ESP Block

pudendal group

ACTIVE COMPARATOR

Bilateral transperineal block will be performed

Procedure: Pudendal Block

Interventions

Sacral ESP Block PROCEDURE

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

espb group

Pudendal Block PROCEDURE

Bilateral pudendal block, 10 ml %0,25 bupivacaine

pudendal group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only males have got prostate
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- American Society of Anesthesiologist (ASA) Physical status 1-3

You may not qualify if:

• 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

Sponsors & Collaborators

• Giresun University: lead

Study Sites (1)

Giresun Research and Training Hospital

Merkez, Giresun, 28100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Bilge Olgun Keleş

  Giresun University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: November 12, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

TU (1)