NCT05012137

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nerve Block

Interventions

Type	Name	Description
PROCEDURE	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)
DRUG	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

Timeline

• Start date: 2021-08-25
• Primary completion: 2021-10-25
• Completion: 2021-11-25
• First posted: 2021-08-19
• Last updated: 2021-08-27

Locations

1 site across 1 country: China