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

Not Applicable

• Conditions: Nerve Block
• Interventions: Procedure: Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB) with 0.5% ropivacaine; Drug: different volume of 0.5% ropivacaine

• Registration Number: NCT05012137
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-12
• Study First Submitted QC: 2021-08-12
• Study First Posted: 2021-08-19
• Last Update Submitted: 2021-08-23
• Study Start: 2021-08-25
• Last Update Posted: 2021-08-27
• Primary Completion: 2021-10-25
• Study Completion: 2021-11-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SASIS-FICB	Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB) with 0.5% ropivacaine	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)
SASIS-FICB	different volume of 0.5% ropivacaine	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)

Primary Outcome Measures

Name	Time	Method
The MEV90 of 0.5%Ropivacaine in Ultrasound-guided SASIS-FICBS	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.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China