- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03853460
Bilateral Quadraus LUMBORUM Block in Patients Under Going Cystectomy
November 2, 2019 updated by: Rasha Hamed, Assiut University
ultrasound guided quadratus lumborum will be given for patients under going partial or complete urinary bladder removal.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
ultrasound guided quadratus lumborum will be given for patients under going partial or complete urinary bladder removal.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Assiut, Egypt, 71111
- Recruiting
- Assiut University
-
Contact:
- rasha hamed, MD
- Phone Number: 0882413201
- Email: amira_salem2015@yahoo.com
-
Asyut, Egypt, 71111
- Recruiting
- Faculty of medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- elective surgery
- patients between 30 and 60 years
Exclusion Criteria:
- coagulopathy
- infection at insertion site
- patient refusal
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: epidural group
ULTRASOUND GUIDED thoracic epidural at T 12 WILL BE INSERTED before anaesthesia induction
|
ultrasound low frequency probe will be used to determine the depth of the posterior complex to assists placement of midline thoracic epidural
|
|
ACTIVE_COMPARATOR: quadus lumborum group
bilateral ultrasound guided quadratus lumborum catheter will be inserted before anaesthesia induction
|
ultrasound guided placement of bilateral quadratus lumborum catheters
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain score
Time Frame: 24 hours
|
Visual analogue score from 0 to 10 will be used to assess pain postoperative.
0 means no pain.
10 is worst pain
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
anaesthetic consumption
Time Frame: 4 hours
|
calculating the total anaesthetic MAC consumed
|
4 hours
|
|
diaphragmatic excursion
Time Frame: 24 hours
|
assessment of diaphragmatic excursion preoperative and postoperative using low frequency ultrasound probe
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 30, 2019
Primary Completion (ANTICIPATED)
May 30, 2020
Study Completion (ANTICIPATED)
December 30, 2020
Study Registration Dates
First Submitted
February 20, 2019
First Submitted That Met QC Criteria
February 22, 2019
First Posted (ACTUAL)
February 25, 2019
Study Record Updates
Last Update Posted (ACTUAL)
November 5, 2019
Last Update Submitted That Met QC Criteria
November 2, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QLMD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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