Qudratus Lumborum Block Versus Unilateral Intrathecal Block for Inguinal Hernia Repair

April 5, 2021 updated by: Hala mohamed Rashad mohamed, Zagazig University

Ultrasound Guided Qudratus Lumborum Block Versus Unilateral Intrathecal Block for Patient Undergoing Inguinal Hernia Repair

compare between Quadratus lumborum block and unilateral intrathecal block for patients undergoing inguinal hernia repair regarding the quality of anesthesia and hemodynamic stability of patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

comparison between unilateral intrathecal block anesthesia (unilateral SA) and Quadratus lumborum block for inguinal hernia repair unilateral intrathecal block is widely used nowadays for unilateral inguinal hernia repair, providing intense sensory and motor blockade. Limiting the block to the operative site by using small doses of hyperbaric solutions injected slowly through a directional needle and maintaining a lateral decubitus position for a certain duration has been proposed, to produce high quality, long-duration analgesia, with minimal hemodynamic adverse events.

Previous case report studies stated that we can use Quadratus Lumborum Block as the sole anesthetic technique for open hernia repair.

Study Type

Interventional

Enrollment (Anticipated)

50

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 Contact

Study Contact Backup

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

- physical status ASA: I-II BMI >18kg/m2<30kg/m2 written informed consent from the patient scheduled for open unilateral inguinal hernia repair

Exclusion Criteria:

  • uncooperative patient
  • Allergy to local anesthetic drugs
  • patients on chronic alcohol, opioid, tranquilizer or sedative use
  • Pregnant females.
  • Psychological, mental disorders, or depression.
  • Patients receiving anticoagulants therapy or suspected coagulopathy.
  • Patients with infection or previous surgery at sit of anesthetic procedures.
  • Patients with significant cardiovascular, respiratory, renal, hepatic, or metabolic disease

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: intrathecal block
patients (25) will receive unilateral intrathecal block using 1.5 ml of hyperbaric bupivacaine
Procedure: unilateral intrathecal block
Quadratus lunborum block
Other Names:
  • unilateral spinal anaesthesia
Active Comparator: Quadratus lumborum block
patients (25) will receive quadratus lumborum block by an anterior approach using 30 ml of bupivacaine 0.25%
Procedure: unilateral intrathecal block
Quadratus lunborum block
Other Names:
  • unilateral spinal anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess safety of quadratus lumborum block vs unilateral intrathecal block for inguinal hernia repair: complications of the block
Time Frame: 2 hours
complications of the block in each group like inadequate blockade detected by increased dose of sedation required in this group ,hemodynamic instability related to the block detected by frequent monitoring of the blood pressure and heart rate
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the onset and duration of sensory block between both blocks
Time Frame: 12 hours
the onset of pin brick discrimination and time of first request of analgesics after block performance in each group
12 hours
To compare the time to ambulation
Time Frame: 24 hours
the time till the patient succeed in ambulation
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

May 1, 2021

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

March 15, 2021

First Submitted That Met QC Criteria

March 15, 2021

First Posted (Actual)

March 18, 2021

Study Record Updates

Last Update Posted (Actual)

April 6, 2021

Last Update Submitted That Met QC Criteria

April 5, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Qudratus lumborum block

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

1 year

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

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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