NCT04827043

Brief Summary

This study is to assess and compare the analgesic efficacy and safety of quadratus lumbotum block and paravertebral block in gynacological cancer patients.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Status
unknown

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

March 9, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

March 9, 2021

Last Update Submit

March 31, 2021

Conditions

Postoperative Analgesia

Keywords

Quadratus lumborum blockThoracic paravertebral blockPostoperative analgesia

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale

    Pain score will be measured according to severity

    Baseline pain till first 24 hours postoperative

Secondary Outcomes (2)

  • Morphine demands postoperative

    First 24 hours postoperative

  • Patient satisfaction

    First 24 hours postoperative

Study Arms (2)

Quadratus lumborum block

EXPERIMENTAL

QLB group: will receive 0.3ml/Kg bupivacaine 0.25% ( keeping in mind not to exceed the maximum recommended toxic dose of plain bupivacaine which is 2.5 mg/Kg \& 3mg/Kg with epinephrine), single injection sonar guided.

Combination Product: Ultrasound guided quadratus lumborum block

Thoracic paravertebral block

EXPERIMENTAL

PVB group: will receive 0.25ml/Kg/side of 0.375% bupivacaine with epinephrine 5ug/ml, yielding the same dose of bupivacaine of 1.875mg/ml at the level of T10 as a single injection sonar guided.

Combination Product: Ultrasound guided thoracic paravertebral block

Interventions

Ultrasound guided quadratus lumborum blockCOMBINATION_PRODUCT

prospective randomized comparative study between Group (1) : quadratus lumborum block

Also known as: QLB
Quadratus lumborum block
Ultrasound guided thoracic paravertebral blockCOMBINATION_PRODUCT

PVB group: will receive 0.25ml/Kg/side of 0.375% bupivacaine with epinephrine 5ug/ml, yielding the same dose of bupivacaine of 1.875mg/ml at the level of T10 as a single injection sonar guided.

Also known as: PVB
Thoracic paravertebral block

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-III.
  • Age ≥ 20 \& ≤ 70
  • Body mass index (BMI): Less than forty and more than twenty.
  • Patients undergoing major gynacological cancer surgeries.

You may not qualify if:

  • Patient refusal.
  • History of sensitivity to local anesthetic (amide group).
  • History of psychological disorders.
  • Coagulopathies: hereditary (e.g. hemophilia, fibrinogen abnormalities\& deficiency of factor II) - acquired (e.g. liver disease, vitamin K deficiency \& therapeutic anticoagulants drugs).
  • Localized infection.
  • Morbid obese BMI\>40.
  • Incooperative patients.
  • Patients on chronic pain therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.

    PMID: 28154824BACKGROUND

  • Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.

    PMID: 27755488BACKGROUND

Study Officials

  • Khaled A El-samahy, Professor

    National Cancer Institute (NCI)

    STUDY DIRECTOR

  • Ekramy M Abd-elghaffar, MD

    National Cancer Institute (NCI)

    STUDY DIRECTOR

  • Esam Ab Mahran, MD

    National Cancer Institute (NCI)

    STUDY DIRECTOR

Central Study Contacts

Fatma G Hussein, master

CONTACT

00201023431090fatmagomaa54p@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
After approval of The InstitutionalEthics Committee of The National Cancer Institute ,Cairo University, 50 patients scheduled for gynacological cancer surgery will be enrolled in this study
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective randomized comparative study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 9, 2021

First Posted

April 1, 2021

Study Start

April 1, 2021

Primary Completion

July 30, 2021

Study Completion

September 30, 2021

Last Updated

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

Starting in April 2021 Ending in July 2021

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Immediately after publication No end date
Access Criteria
Any one who wishes to access the data
More information