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Clinical Trials/NCT06372691
NCT06372691
Completed
Not Applicable

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

Ankara City Hospital Bilkent1 site in 1 country92 target enrollmentMay 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adult
Sponsor
Ankara City Hospital Bilkent
Enrollment
92
Locations
1
Primary Endpoint
Onset Time
Status
Completed
Last Updated
9 months ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2024
End Date
April 1, 2025
Last Updated
9 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

semih başkan

Doç. Prof. Dr.

Ankara City Hospital Bilkent

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Need for Multiple Injections Owing to Insufficient Anesthesia(Within 24 hours)
  • Additional Rescue Analgesic(Within 24 hours)
  • Block Execution Times(1-10 minutes)
  • Hemodynamic Effects Of The Block(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(Within 24 hours)
  • Total Block Times(Within 24 hours)
  • Adverse Effects to Anesthesia(During the block period, within 24 hours)
  • Effects Of The Block On 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(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)

Study Sites (1)

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