Tokyo, Sept. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063059) titled 'A Study Comparing Ketamine plus Tramadol Combination Therapy with Caudal Block for Preventing Catheter-Related Bladder Discomfort after HoLEP: A Prospective Non-Inferiority Trial' on Sept. 28.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Ohara General Hospital

Condition: Condition - Benign Prostatic Hyperplasia (BPH) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate whether a pharmacological strategy using low-dose ketamine combined with tramadol is non-inferior to sacral epidural block in reducing the incidence of moderate to severe catheter-related bladder discomfort (CRBD) within the first 18 hours after holmium laser enucleation of the prostate (HoLEP) performed under general anesthesia. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intervention Name: Ketamine + Tramadol administration Intervention Type: Drug Description: To prevent postoperative catheter-related bladder discomfort (CRBD) and postoperative pain, patients receive intravenous ketamine 0.25 mg/kg and tramadol 1.5 mg/kg approximately 30 minutes before the end of surgery. Anesthesia induction and maintenance are performed using general anesthesia. Duration: Single administration, approximately 30 minutes before the end of surgery Frequency: One-time Route: Intravenous (IV) Purpose: Prevention of postoperative CRBD and management of postoperative pain Interventions/Control_2 - Intervention Name: Caudal (sacral) epidural block Intervention Type: Procedure Description: After tracheal intubation under general anesthesia, patients are placed in the left lateral decubitus position and receive a caudal epidural block with 20 mL of 0.25% ropivacaine combined with 0.1 mg fentanyl. A 22G, 80-mm curved Huber-type disposable needle is used. General anesthesia maintenance is the same as in the experimental group. The block is performed to prevent postoperative CRBD. Duration: Single administration during surgery after tracheal intubation Frequency: One-time Route: Caudal epidural injection Purpose: Prevention of postoperative CRBD

Eligibility: Age-lower limit - 20 years-old < Age-upper limit - Not applicable Gender - Male Key inclusion criteria - (1)Patients who are capable of providing informed consent. (2)Patients with normal coagulation parameters and no evidence of infection at the puncture site. (3)Patients with no known allergy or hypersensitivity to ketamine or tramadol. Key exclusion criteria - (1)Patients in whom epidural anesthesia (sacral block) cannot be performed due to coagulation disorders, infection at the puncture site, or other contraindications. (2)Patients who do not wish to participate in this study. (3)Patients who refuse or have a predetermined preference for a specific anesthesia method and therefore do not consent to study allocation. Target Size - 110

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 11 Month 21 Day Date of IRB - 2025 Year 11 Month 21 Day Anticipated trial start date - 2025 Year 12 Month 01 Day Last follow-up date - 2028 Year 12 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068470

Disclaimer: Curated by HT Syndication.