- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06489210
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
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
Interventional
Enrollment (Actual)
120
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 Locations
-
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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
|
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
|
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
|
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
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
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)
April 1, 2018
Primary Completion (Actual)
April 30, 2021
Study Completion (Actual)
April 30, 2021
Study Registration Dates
First Submitted
June 20, 2024
First Submitted That Met QC Criteria
July 3, 2024
First Posted (Actual)
July 5, 2024
Study Record Updates
Last Update Posted (Actual)
July 5, 2024
Last Update Submitted That Met QC Criteria
July 3, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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
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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