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Bilateral Quadraus LUMBORUM Block in Patients Under Going Cystectomy

Primary Purpose

Pain, Acute

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
epidural catheter
nerve block catheter
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Acute

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • elective surgery
  • patients between 30 and 60 years

Exclusion Criteria:

  • coagulopathy
  • infection at insertion site
  • patient refusal

Sites / Locations

  • Assiut universityRecruiting
  • Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

epidural group

quadus lumborum group

Arm Description

ULTRASOUND GUIDED thoracic epidural at T 12 WILL BE INSERTED before anaesthesia induction

bilateral ultrasound guided quadratus lumborum catheter will be inserted before anaesthesia induction

Outcomes

Primary Outcome Measures

pain score
Visual analogue score from 0 to 10 will be used to assess pain postoperative. 0 means no pain. 10 is worst pain

Secondary Outcome Measures

anaesthetic consumption
calculating the total anaesthetic MAC consumed
diaphragmatic excursion
assessment of diaphragmatic excursion preoperative and postoperative using low frequency ultrasound probe

Full Information

First Posted
February 20, 2019
Last Updated
November 2, 2019
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03853460
Brief Title
Bilateral Quadraus LUMBORUM Block in Patients Under Going Cystectomy
Official Title
Bilateral Quadraus LUMBORUM Block in Patients Under Going Cystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2019 (Actual)
Primary Completion Date
May 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
ultrasound guided quadratus lumborum will be given for patients under going partial or complete urinary bladder removal.
Detailed Description
ultrasound guided quadratus lumborum will be given for patients under going partial or complete urinary bladder removal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
both patients and data collector will be unaware of the group nature
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
epidural group
Arm Type
Active Comparator
Arm Description
ULTRASOUND GUIDED thoracic epidural at T 12 WILL BE INSERTED before anaesthesia induction
Arm Title
quadus lumborum group
Arm Type
Active Comparator
Arm Description
bilateral ultrasound guided quadratus lumborum catheter will be inserted before anaesthesia induction
Intervention Type
Procedure
Intervention Name(s)
epidural catheter
Intervention Description
ultrasound low frequency probe will be used to determine the depth of the posterior complex to assists placement of midline thoracic epidural
Intervention Type
Procedure
Intervention Name(s)
nerve block catheter
Intervention Description
ultrasound guided placement of bilateral quadratus lumborum catheters
Primary Outcome Measure Information:
Title
pain score
Description
Visual analogue score from 0 to 10 will be used to assess pain postoperative. 0 means no pain. 10 is worst pain
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
anaesthetic consumption
Description
calculating the total anaesthetic MAC consumed
Time Frame
4 hours
Title
diaphragmatic excursion
Description
assessment of diaphragmatic excursion preoperative and postoperative using low frequency ultrasound probe
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: elective surgery patients between 30 and 60 years Exclusion Criteria: coagulopathy infection at insertion site patient refusal
Facility Information:
Facility Name
Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
rasha hamed, MD
Phone
0882413201
Email
amira_salem2015@yahoo.com
Facility Name
Faculty of Medicine
City
Asyut
ZIP/Postal Code
71111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
rasha hamed
Phone
01000440773
Email
rashaahmed11@yahoo.com
First Name & Middle Initial & Last Name & Degree
saeed elsawy
Phone
01030072161
Email
saeedelsawy17@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Bilateral Quadraus LUMBORUM Block in Patients Under Going Cystectomy

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