How Do We Ultrasound-Guided Popliteal Approach Sciatic Nerve Block?

April 15, 2024 updated by: semih başkan, Ankara City Hospital Bilkent

How Do We Ultrasound-Guided Popliteal Approach Sciatic Nerve Block;Is It Injection Subparaneural, Interneural?

The aim of this prospective, randomized, observer-blind study to compare subparaneural approach injection with interneural approach injection in popliteal sciatic nerve blocks.

Study Overview

Detailed Description

The study will involve American Society of Anesthesiologists Physical Status Classification (ASA) III or IV risk group patients, 18 years of age or older, who will undergoing foot, ankle, or toe amputation.

Supparaneural injection (Group S) and interneural injection method (Group I) will the two research groups to which patients were randomly allocated.

Every 5 minutes following LA injection, an investigator who will blind to randomization will assess the sensory and motor blockage in the operated foot. The study will documented the operative time, block characteristics, such as the duration of block administration, sensory and motor block start and regression times, the time of extra analgesic required, and the occurrence of complications.

Study Type

Interventional

Enrollment (Estimated)

809

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years and over
  • Planned foot, ankle or toe amputation
  • ASA III-IV risk group
  • Patients who agreed to be included in the study

Exclusion Criteria:

  • People with neurological and psychiatric diseases
  • Using opioids or another analgesic for chronic pain
  • Allergic to local anesthetics
  • Pregnant or breastfeeding
  • Those with infection or sepsis in the application area
  • Patients who did not agree to be included in the study

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Subparaneural Injection (Group S)
The position of the patients will be prone.The skin will be cleaned according to asepsis and antisepsis rules.After preparing the USG a high-frequency linear array transducer under sterile conditions,we will be positioned it transversely in the popliteal fossa.After visualizing the artery,its hyperechoic nerves will be founded superficially.The sciatic nerve will be identified proximally to visualize where the TN and CPN eventually come together to form the sciatic nerve and separate distally where the CPN moves laterally and the TN remains medially.Once the nerves began to separate,they will be scanned until a figure 8 or pant leg image will be obtained.Using the in-plane technique under ultrasonography guidance, injection will be applied to the subparaneural area in Group S.1 ml of LA solution was injected for the purpose of verifying proper needle insertion.A standard dose of 15 mL bupivacaine 0.5% and 5mg/mL local anesthetic was used accompanied by a 20G,12mm block needle.
Comparison of two different methods in terms of various features
Active Comparator: Interneural Injection (Group I)
The position of the patients will be prone.The skin will be cleaned according to asepsis and antisepsis rules.After preparing the USG a high-frequency linear array transducer under sterile conditions, we will be positioned it transversely in the popliteal fossa.After visualizing the artery, its hyperechoic nerves will be founded superficially.The sciatic nerve will be identified proximally to visualize where the TN and CPN eventually come together to form the sciatic nerve and separate distally where the CPN moves laterally and the TN remains medially.Once the nerves began to separate, they will be scanned until a figure 8 or pant leg image will be obtained.Using the in-plane technique under ultrasonography guidance, injection will be applied to the interneural area in Group I.1 ml of LA solution was injected for the purpose of verifying proper needle insertion.A standard dose of 15 mL bupivacaine 0.5% and 5mg/mL local anesthetic was used accompanied by a 20 G, 12mm block needle.
Comparison of two different methods in terms of various features

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Onset Time
Time Frame: Time from the moment the block is made to the moment it starts, within the first half hour
Onset time will be defined as the moment when it is determined that the block is successful.
Time from the moment the block is made to the moment it starts, within the first half hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Block Execution Times
Time Frame: 1-10 minutes
The time from the moment the block starts to the moment the transaction ends.
1-10 minutes
Need for Multiple Injections Owing to Insufficient Anesthesia
Time Frame: Within 24 hours
How many blocks should be made.
Within 24 hours
Additional Rescue Analgesic
Time Frame: Within 24 hours
Analgesic use status.
Within 24 hours
Adverse Effects to Anesthesia
Time Frame: During the block period, within 24 hours
hypotension, agitation, nausea, vomiting, dizziness
During the block period, within 24 hours
Hemodynamic Effects Of The Block
Time Frame: 0th minutes, 5th minutes,10th minutes,15th minutes,20th minutes,25th minutes,30th minutes,35th minutes,40th minutes,45th minutes,50th minutes,55th minutes and 60th minutes and then at 1-hour intervals and 15th minutes,30th minutes
Noninvasive systolic and diastolic blood pressure
0th minutes, 5th minutes,10th minutes,15th minutes,20th minutes,25th minutes,30th minutes,35th minutes,40th minutes,45th minutes,50th minutes,55th minutes and 60th minutes and then at 1-hour intervals and 15th minutes,30th minutes
Effects Of The Block On Heart Rate
Time Frame: 0th minutes, 5th minutes,10th minutes,15th minutes,20th minutes,25th minutes,30th minutes,35th minutes,40th minutes,45th minutes,50th minutes,55th minutes and 60th minutes and then at 1-hour intervals and 15th minutes,30th minutes
Heart rate
0th minutes, 5th minutes,10th minutes,15th minutes,20th minutes,25th minutes,30th minutes,35th minutes,40th minutes,45th minutes,50th minutes,55th minutes and 60th minutes and then at 1-hour intervals and 15th minutes,30th minutes
Effects Of The Block On Peripheral Pulse Oximetry
Time Frame: 0th minutes, 5th minutes,10th minutes,15th minutes,20th minutes,25th minutes,30th minutes,35th minutes,40th minutes,45th minutes,50th minutes,55th minutes and 60th minutes and then at 1-hour intervals and 15th minutes,30th minutes
Peripheral pulse oximetry
0th minutes, 5th minutes,10th minutes,15th minutes,20th minutes,25th minutes,30th minutes,35th minutes,40th minutes,45th minutes,50th minutes,55th minutes and 60th minutes and then at 1-hour intervals and 15th minutes,30th minutes
Regression Time Of Sensory and Motor Block
Time Frame: Within 24 hours
When the block starts to come back.
Within 24 hours
Total Block Times
Time Frame: Within 24 hours
How long the block took in total.
Within 24 hours

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Semih Başkan, Ankara City Hospital Bilkent

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 (Estimated)

May 1, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

April 1, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • PoplitealApproach SciaticBlock

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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