NCT03853460

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

October 30, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

November 5, 2019

Status Verified

November 1, 2019

Enrollment Period

7 months

First QC Date

February 20, 2019

Last Update Submit

November 2, 2019

Conditions

Pain, Acute

Outcome Measures

Primary Outcomes (1)

  • pain score

    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 Outcomes (2)

  • anaesthetic consumption

    4 hours

  • diaphragmatic excursion

    24 hours

Study Arms (2)

epidural group

ACTIVE COMPARATOR

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

Procedure: epidural catheter

quadus lumborum group

ACTIVE COMPARATOR

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

Procedure: nerve block catheter

Interventions

epidural catheterPROCEDURE

ultrasound low frequency probe will be used to determine the depth of the posterior complex to assists placement of midline thoracic epidural

epidural group
nerve block catheterPROCEDURE

ultrasound guided placement of bilateral quadratus lumborum catheters

quadus lumborum group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • elective surgery
  • patients between 30 and 60 years

You may not qualify if:

  • coagulopathy
  • infection at insertion site
  • patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Assiut university

Asyut, 71111, Egypt

RECRUITING

Faculty of Medicine

Asyut, 71111, Egypt

RECRUITING

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
both patients and data collector will be unaware of the group nature
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anaesthesia and pain management

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 25, 2019

Study Start

October 30, 2019

Primary Completion

May 30, 2020

Study Completion

December 30, 2020

Last Updated

November 5, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)