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

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).

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06127394
Acronym
SESPB
Enrollment
54
Registered
2023-11-13
Start date
2023-11-12
Completion date
2023-12-15
Last updated
2024-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

regional block, pudendal block

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.

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.

Interventions

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

Bilateral pudendal block, 10 ml %0,25 bupivacaine

Sponsors

Giresun University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Catheter related bladder discomfort, 0:no discomfort 4:worst discomfortbaseline ,and 24 hoursIt 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

MeasureTime frameDescription
Numerical Rating Scale,0 :no pain 10:worst painbaseline, and 24 hoursThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026