UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054259 |
|---|---|
| Receipt number | R000061963 |
| Scientific Title | Trans-perineal Ultrasound Guided Pudendal Nerve Block and Post-Hemorrhoidectomy Voiding complications |
| Date of disclosure of the study information | 2024/04/25 |
| Last modified on | 2024/04/25 18:24:34 |
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Basic information
Public title
Trans-perineal Ultrasound Guided Pudendal Nerve Block and Post-Hemorrhoidectomy Voiding complications
Acronym
US pudendal nerve block for Post-Hemorrhoidectomy Voiding complications
Scientific Title
Trans-perineal Ultrasound Guided Pudendal Nerve Block and Post-Hemorrhoidectomy Voiding complications
Scientific Title:Acronym
US pudendal nerve block for Post-Hemorrhoidectomy Voiding complications
Region
| Asia(except Japan) |
Condition
Condition
The study will include adult patients of both gender, suffering of hemorrhoids grade 3-4 and planned open hemorrhoidectomy (Milligan-Morgan hemorrhoidectomy) under general anesthesia.
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study hypothesizes that US guided trans-perineal approach is a safe applicable technique that would decrease the incidence of PHUR (primary outcome). Secondary variables will include; postoperative pain scores, postoperative voiding symptoms, postoperative analgesia consumption.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
the incidence of post-haemorhdectomy urinary retentin (primary outcome) measured in the irst 24 hours after surgery
Key secondary outcomes
Secondary variables will include; postoperative pain scores, postoperative voiding symptoms, postoperative analgesia consumption.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
While the patient is in lithotomy position, US guided pudendal nerve block will be eprformed using bupivecaine 0.25 % 5 ml on each side
Interventions/Control_2
perineal local anesthetic infiltration( lidocaine 1% 10 ml).
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
adult patients of both gender,
suffering of hemorrhoids grade 3-4 and
planned open hemorrhoidectomy (Milligan-Morgan hemorrhoidectomy)
under general anesthesia
Key exclusion criteria
Patients with known allergy to bupivacaine,
redo surgery,
preoperative voiding problems,
prostatic hyperplasia,
neurological disease affecting voiding control or patient ability to communicate will be excluded from the study.
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Fahd |
| Middle name | Saeed |
| Last name | Alamry |
Organization
King khalid University-Abha-KSa
Division name
Surgery department
Zip code
62521
Address
Abha-Asir-KSA
TEL
+966504782778
fsalamri@kku.edu.sa
Public contact
Name of contact person
| 1st name | Alrefaey |
| Middle name | K |
| Last name | Alrefaey |
Organization
Mansoura University- Egypt
Division name
Anestheia department
Zip code
35516
Address
Mansoura-Egypt
TEL
00201064203475
Homepage URL
refa3ey2@mans.edu.eg
Sponsor or person
Institute
King Khalid University-Abha-Asir-KSA
Institute
Department
Personal name
Funding Source
Organization
self funded
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee at King Khalid University
Address
Abha-Asir-KSA
Tel
00966504782778
ecm@kku.edu.sa
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
| 2024 | Year | 04 | Month | 25 | 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
Deprsonalised individual patient data is planned for sharing to any researcher or institution covered by ethical committee or similar through contacting email refa3ey22yahoo.com within 12 month of study comletion
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 25 | Day |
Last modified on
| 2024 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061963
