The MEV of 0.5% Ropivacaine in Ultrasound-guided SASIS-FICB

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-25

Study Completion Date

2021-11-25

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nerve Block

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a dosing exploratory study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

all the patients received Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB)

different volume of 0.5% ropivacaine

Intervention Type DRUG

According to the subject's response to the injection dose, the next subject will be injected with a different volume of the drug according to the preset rules

Interventions

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

all the patients received Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB)

Intervention Type PROCEDURE

different volume of 0.5% ropivacaine

According to the subject's response to the injection dose, the next subject will be injected with a different volume of the drug according to the preset rules

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No