UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063059 |
|---|---|
| Receipt number | R000068470 |
| Scientific Title | A Prospective Non-Inferiority Trial Comparing the Efficacy of Ketamine plus Tramadol versus Caudal Block for Preventing Post-Operative Catheter-Related Bladder Discomfort following Holmium Laser Enucleation of the Prostate (HoLEP) |
| Date of disclosure of the study information | 2026/09/28 |
| Last modified on | 2026/09/28 16:22:22 |
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Basic information
Public title
A Study Comparing Ketamine plus Tramadol Combination Therapy with Caudal Block for Preventing Catheter-Related Bladder Discomfort after HoLEP: A Prospective Non-Inferiority Trial
Acronym
Ketamine plus tramadol vs caudal block for CRBD after HoLEP Trial
Scientific Title
A Prospective Non-Inferiority Trial Comparing the Efficacy of Ketamine plus Tramadol versus Caudal Block for Preventing Post-Operative Catheter-Related Bladder Discomfort following Holmium Laser Enucleation of the Prostate (HoLEP)
Scientific Title:Acronym
CRBD-HoLEP Non-Inferiority Trial (Ketamine plus tramadol vs Caudal block)
Region
| Japan |
Condition
Condition
Benign Prostatic Hyperplasia (BPH)
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the incidence of moderate to severe catheter-related bladder discomfort (CRBD) within the first 18 hours after surgery. CRBD severity will be evaluated using a standardized four-grade scale (none, mild, moderate, severe). The proportion of patients experiencing moderate or severe CRBD will be compared between the ketamine-tramadol group and the sacral epidural block group to assess non-inferiority within a 15% margin.
Key secondary outcomes
Secondary outcomes include the time-course of CRBD severity at 0, 4, 6, 12, and 18 hours postoperatively; intraoperative opioid consumption; the incidence of PONV; the use of rescue analgesics; patient satisfaction; and adverse events related to either intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
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
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Chiaki |
| Middle name | |
| Last name | Nemoto |
Organization
Ohara General Hospital
Division name
Department of Anesthesia
Zip code
960-8611
Address
6-1 Ohomachi, Fukushima
TEL
024-526-0300
hippo.hippo1970@gmail.com
Public contact
Name of contact person
| 1st name | Chiaki |
| Middle name | |
| Last name | Nemoto |
Organization
Ohara General Hospital
Division name
Department of Anesthesia
Zip code
960-8611
Address
6-1 Ohomachi, Fukushima
TEL
024-526-0300
Homepage URL
hippo.hippo1970@gmail.com
Sponsor or person
Institute
Ohara General Hospital
Institute
Department
Personal name
Funding Source
Organization
Ohara General Hospital
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ohara General Hospital
Address
6-1 Ohomachi, Fukushima
Tel
024-526-0300
hippo.hippo1970@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 26 | Day |
Last modified on
| 2026 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068470
