NCT05089994

Brief Summary

To compare the postoperative analgesic effect of two ultrasound guided approaches of quadratus lumborum block (QLB) (anterior and intramuscular) for radical cystectomy.

Trial Health

57
Monitor

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 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

October 6, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2024

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2024

Completed
Last Updated

July 31, 2024

Status Verified

June 1, 2024

Enrollment Period

2.9 years

First QC Date

May 22, 2021

Last Update Submit

July 30, 2024

Conditions

Quadratus Lumborum Block

Outcome Measures

Primary Outcomes (1)

  • Evaluate the first call for rescue analgesia

    The time of the first call of analgesia is recorded

    24hours after recovery From anesthesia

Secondary Outcomes (1)

  • Total doses of morphine required

    24hours after recovery from anesthesia

Study Arms (2)

Group 1 (QLBA) will include 30 patients

EXPERIMENTAL

will receive ultrasound-guided anterior approach quadratus lumborum block

Procedure: US guided injection

Group 2 (QLBI)will include 30 patients.

EXPERIMENTAL

received ultrasound-guided intramuscular quadratus lumborum.

Procedure: US guided injection

Interventions

US guided injectionPROCEDURE

using 2.5mg/kg of 0.25% bupivacaine diluted in a 20 mL syringe of normal saline , received ultrasound-guided quadratus lumborum.

Group 1 (QLBA) will include 30 patientsGroup 2 (QLBI)will include 30 patients.

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 40-70years.
  • BMI: 20-30 kg.m2
  • Sex: both males and females.
  • American Society of Anesthesiologists (ASA )physical status: I-III.
  • Operation: radical cystectomy

You may not qualify if:

  • Patient's refusal to participate in the study.
  • known allergy to local anesthesia (LA),
  • coagulopathy or thrombocytopenia,
  • body mass index (BMI) above 30 kg .m 2, and infection at site of injection.
  • Chronic pain syndromes,
  • Prolonged opioid medication,
  • Patients on regular use of analgesic or who received analgesic 24 h before surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit university urology hospital

Asyut, Egypt

RECRUITING

Central Study Contacts

Hassan Mostafa abdelbaky ahmed, Master

CONTACT

01060264751hassan.mostafa9444@gmail.com

Abdel raheem Mahmoud Mohamed, Prof

CONTACT

01000032655

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Comparison of Two Approaches of Quadratus Lumborum Block for Post-operative Analgesia in Radical Cystectomy

Study Record Dates

First Submitted

May 22, 2021

First Posted

October 22, 2021

Study Start

October 6, 2021

Primary Completion

September 4, 2024

Study Completion

September 25, 2024

Last Updated

July 31, 2024

Record last verified: 2024-06

Locations

EG(1)