A Comparison Between Posterior, Lateral and Medial Approaches for Ultrasound-guided Popliteal Block

July 3, 2024 updated by: Adel Ali Hassan, Helwan University

A Comparison Between Posterior, Lateral and Medial Approaches for Ultrasound-guided Popliteal Block: A Randomized Clinical Study

Background: Popliteal block is a widely used technique to provide anesthesia or analgesia for below-knee surgical procedures. In this study, the investigators compare ultrasound-guided popliteal blocks via posterior, lateral, and medial approaches to find out the approach with the best outcome.

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

Methods: In this randomized, controlled clinical trial, one hundred and twenty ASA physical status of class I and II patients undergoing below-knee surgery were involved. These patients were divided into three equal groups at randomly based on the route assigned for the US-guided popliteal block: the posterior, lateral, and medial approach groups. In this study, technical characteristics [number of attempts to get the proper injection site and block performance time], anesthetic and analgesic characteristics [success rate, block onset, potency, and duration, time to ask, and the consumed amount of postoperative analgesia], discomfort rate in respect to position and needle insertion and the associated complications were recorded.

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.
120

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.
  • 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 Locations

  • Egypt
      • Zagazig, Egypt
        • Zagazig University Hospitals

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria: This study included

  • ASA physical status (PS) class I and II
  • weighing 70-85 kg,
  • undergoing elective below knee surgeries

Exclusion Criteria:

  • patients who refused to participate in the study
  • those having an allergy to local anesthetics
  • peripheral neuropathy, coagulopathy
  • diabetes mellitus
  • severe hepatic
  • renal impairment
  • infection, mass and crush injury or open wound at the nerve block site
  • patients receiving chronic analgesic therapy.

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: Single

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.
Active Comparator: popliteal block posterior approach group
through posterior approach ultrasound guided sciatic nerve block at popliteal fossa 20ml of the selected local anesthetic mixture (10ml of 0.5% bupivacaine mixed with 10ml of 2% lidocaine, each with 1:200,000 epinephrine) was injected incrementally
Procedure: popliteal block
using ultrasound to detect sciatic nerve and popliteal fossa through different approaches using 20ml of the selected local anesthetic mixture (10ml of 0.5% bupivacaine mixed with 10ml of 2% lidocaine, each with 1:200,000 epinephrine) was injected incrementally
Active Comparator: popliteal block lateral approach group
ultrasound guided sciatic nerve block at popliteal fossa through lateral approach 20ml of the selected local anesthetic mixture (10ml of 0.5% bupivacaine mixed with 10ml of 2% lidocaine, each with 1:200,000 epinephrine) was injected incrementally
Procedure: popliteal block
using ultrasound to detect sciatic nerve and popliteal fossa through different approaches using 20ml of the selected local anesthetic mixture (10ml of 0.5% bupivacaine mixed with 10ml of 2% lidocaine, each with 1:200,000 epinephrine) was injected incrementally
Active Comparator: poplitea block medial approach group
ultrasound guided sciatic nerve block at popliteal fossa through medial approach 20ml of the selected local anesthetic mixture (10ml of 0.5% bupivacaine mixed with 10ml of 2% lidocaine, each with 1:200,000 epinephrine) was injected incrementally
Procedure: popliteal block
using ultrasound to detect sciatic nerve and popliteal fossa through different approaches using 20ml of the selected local anesthetic mixture (10ml of 0.5% bupivacaine mixed with 10ml of 2% lidocaine, each with 1:200,000 epinephrine) was injected incrementally

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
assessment of intraoperative and postoperative pain in different groups after intervention
Time Frame: 24 hours after operation
pain severity levels via visual analogue scale (VAS). VAS is a 10 cm horizontal line labeled "no pain" at one end and "worst pain" imaginable on the other end. The patient was asked to mark on this line where the intensity of the patient lies
24 hours after operation

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.
Helwan University

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.
April 1, 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.
April 30, 2021

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.
April 30, 2021

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).
June 20, 2024

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.
July 3, 2024

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.
July 5, 2024

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.
July 5, 2024

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.
July 3, 2024

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.
July 1, 2024

More Information

Terms related to this study

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.
  • 4428-4-3-2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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