Psoas Compartment Block (PCB) Versus L.A Infiltration and Remifentanil Infusion During EVAR

February 14, 2019 updated by: DR. Osama Mohamed Farahat, Dr. Erfan and Bagedo General Hospital

Comparative Study Between Psoas Compartment Block (PCB) Versus Local Anesthesia With Remifentanil Infusion for Endovascular Repair of Abdominal Aortic Aneurysm (EVAR): A Randomized Controlled Trial

Endovascular aneurysm repair (EVAR) was introduced in 1990 for the first time as a minimally invasive procedure instead of the conventional open surgical repair, with the aim to decrease morbidity and mortality . Nowadays EVAR has become an acceptable management for patients with infra-renal aortic aneurysms (AAA) . A lot of anesthetic techniques have been used successfully for EVAR. EVAR requires sedative analgesic medications to achieve an acceptable level of comfort to the patient and cardiorespiratory stability.

This is prospective randomized single blinded study of patients presenting with aorto-iliac aneurysm who will undergo EVAR. Patient's demographic data will be assessed, as well as clinical presentation, intraoperative complications.

30 patients undergoing elective EVAR will be included and will be divided equally into 2 groups.

First group is the psoas compartment block (PCB) (15 patients): 30 ml of bupivacaine 0.25% will be infused over 3 minutes at the anatomical landmark.

Second group is the LA and remifentanil group (LR) (15 patients): lidocaine 5 ml of 2% will be injected subcutaneous as local infiltration then remifentanil infusion with rate 0.03-0.1 μg kg-1 min-1. to achieve visual analog scale (VAS) 3 or less.

Vital date will be recorded as baseline then every 5 minutes till the end of the procedure. VAS will be recorded as baseline then every 5 minutes till the end of the procedure. Also stress response which will be measured subjectively as vital data and VAS and objectively as cortisol level in the blood which will be measured as base line and immediate after the end of the procedure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Anatomical, imaging and clinical studies suggest that psoas compartment block (PCB) which was done at L2-L3 level has a high possibility to include L1-L2 roots, and thus can be suitable for inguinal surgery. In our study, the investigators introduce a modified PCB which will be performed in lateral decubitus by a 120 mm stimulated needle inserted at the junction between the lateral third and the medial two-thirds of a line drawn at L2-L3 interspace, between the interspinous line and a line passing through the posterior superior iliac spine (PSIS), parallel to the interspinous line . If twitching of the anterior thigh area is observed, the needle is moved slight cranially. When twitching of the inguinal field is observed, bupivacaine 0.5% 30 ml, will be injected

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Jeddah, Saudi Arabia, 0000
        • DR Erfan hospital
      • Jeddah, Saudi Arabia
        • Erfan hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All elective patients presenting with aortoiliac aneurysm who will undergo percutaneous EVAR.

Exclusion Criteria:

  • Exclusion criteria included the presence of an aneurysm of the common femoral artery or severe atherosclerotic disease with total occlusion, emergency EVAR, uncooperative patient, patient on anticoagulation therapy, cerebrovascular disease, poorly controlled hypertension (systolic arterial pressure ≥160 mmHg), poorly controlled diabetes mellitus (random blood glucose ≥200 mg/dL) and renal insufficiency (creatinine >1.5 mg/dL).

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Psoas Compartment Block (PCB)
30 ml of bupivacaine 0.25% will be infused over 3 minutes at the anatomical land mark for psoas plexus, also normal saline 0.9% IV infusion will be in the same rate of the Remifentanil infusion for the other group.
Procedure: Psoas Compartment Block (PCB)
30 ml of bupivacaine 0.25% will be infused over 3 minutes at the anatomical landmark for Psoas Compartment Block (PCB)
Drug: Normal saline 0.9% IV infusion
Normal saline 0.9% IV infusion at the same rate of the Remifentanil infusion(0.05-0.1 μg/ kg/min).
Experimental: L.A infiltration /Remifentanil infusion
L.A infiltration (lidocaine) 5 ml of 2% will be injected subcutaneous as L.A infiltration then Remifentanil infusion with rate 0.03-0.1 μg / kg / min to achieve Visual Analog Scale 3 or less.
Procedure: Local Anesthesia infiltration
Lidocaine 5 ml of 2% will be injected subcutaneous as local infiltration.
Drug: Remifentanil infusion
Remifentanil infusion with rate 0.03-0.1 μg/ kg/ min to achieve Visual Analog Scale (VAS) 3 or less

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Visual Analogue Scale (VAS)
Time Frame: Assessment to be done at baseline (immediate before starting the procedure), then every 10 min through study till 4 hours after given the anesthesia.The event was determent via asking patient about pain experience every time using 100 mm VAS

The primary outcome was Visual Analog Scale (VAS) to assess perioperative analgesia and pain management.

Pain was assessed using the 100-mm visual analog scale, ranging from 0 to 100. The lowest score is 0 (no pain/excellent analgesia) and the highest score is 100 (Max pain).
Assessment to be done at baseline (immediate before starting the procedure), then every 10 min through study till 4 hours after given the anesthesia.The event was determent via asking patient about pain experience every time using 100 mm VAS

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Arterial blood pressure
Time Frame: will be recorded at baseline (immediate before starting the procedure), then every 5 min through study till 4 hours after given the anesthesia.
Arterial blood pressure monitoring in mmHg
will be recorded at baseline (immediate before starting the procedure), then every 5 min through study till 4 hours after given the anesthesia.
Satisfactions Score
Time Frame: Time frame include 2 time points, first time point: immediate at the end of the procedure and the second time point: 2 hours after the end of the procedure
Patient and surgeon satisfactions were assessed using the satisfaction score by asking them according to their degree of satisfaction based on this scale, which ranges from 0 to 100 (0 being the lowest score and 100 being the highest score).
Time frame include 2 time points, first time point: immediate at the end of the procedure and the second time point: 2 hours after the end of the procedure
heart rate (HR)
Time Frame: Will be recorded at baseline (immediate before starting the procedure), then every 5 min through study till 4 hours after given the anesthesia.
heart rate monitoring in beat / min
Will be recorded at baseline (immediate before starting the procedure), then every 5 min through study till 4 hours after given the anesthesia.
Oxygen saturation
Time Frame: Will be recorded at baseline (immediate before starting the procedure), then every 5 min through study till 4 hours after given the anesthesia.
Oxygen saturation monitoring in %
Will be recorded at baseline (immediate before starting the procedure), then every 5 min through study till 4 hours after given the anesthesia.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr. Erfan and Bagedo General Hospital

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 6, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 10, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 180101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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