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Clinical Trials/NCT05012137
NCT05012137
Unknown
Not Applicable

The Minimum Effective Volume (MEV) of 0.5% Ropivacaine in Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB)

Peking Union Medical College Hospital1 site in 1 country54 target enrollmentAugust 25, 2021

Overview

Phase
Not Applicable
Intervention
Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB) with 0.5% ropivacaine
Conditions
Nerve Block
Sponsor
Peking Union Medical College Hospital
Enrollment
54
Locations
1
Primary Endpoint
The MEV90 of 0.5%Ropivacaine in Ultrasound-guided SASIS-FICBS
Last Updated
4 years ago

Overview

Brief Summary

The Aim of This Study is to Determine the Minimum Effective Volume of Local Anesthetic (Ropivacaine 0.5%) Required to Produce an Effective Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block(SASIS-FICB) for Surgical Anesthesia in 90% of Patients Scheduled for Elective Surgery of One Lower Limbs.

Detailed Description

The study is based on biased coin design, and the volume of Local Anesthetic (Ropivacaine 0.5%) for the next patient is determined by the result of the last one. In the case of block failure, the volume will be increased by 2.5ml. Conversely, block success will result in either a reduction in volume by 2.5ml (probability 11%) or no change in volume (probability 89%). A blinded assistant will assess sensory and motor blockade in each nerve territory ( the femoral, obturator and lateral femoral cutaneous nerves) at 5-min intervals up to 30 min after completion of the block. Finally, MEV90 is calculated by isotonic regression.

Registry
clinicaltrials.gov
Start Date
August 25, 2021
End Date
November 25, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cui Xulei

Associate Professor

Peking Union Medical College Hospital

Eligibility Criteria

Inclusion Criteria

  • patients undergoing hip/knee surgery

Exclusion Criteria

  • age \<18 years
  • body mass index \>35
  • inability to consent to the study
  • allergy to local anesthetics
  • a history of liver or renal insufficiency, coagulopathy
  • clinical evidence of peripheral neuropathies, abnormalities of sensory or motor function of the FN, ON or LFCN.

Arms & Interventions

SASIS-FICB

All subjects will be enrolled in the experimental group and receive an Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB)

Intervention: Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB) with 0.5% ropivacaine

SASIS-FICB

All subjects will be enrolled in the experimental group and receive an Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB)

Intervention: different volume of 0.5% ropivacaine

Outcomes

Primary Outcomes

The MEV90 of 0.5%Ropivacaine in Ultrasound-guided SASIS-FICBS

Time Frame: up to 6 months

We prospectively recruited patients to receive different volumes of SASIS-FICB in accordance with the sequential trial rules of biased coins until 45 successful SASIS-FICB attempts were completed. MEV90 was calculated by isometric regression.

Study Sites (1)

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