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

Nerve Block Clinical Trial

— SASIS-FICB  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05012137
• Other study ID #: SASIS-FICB
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 25, 2021
• Est. completion date: November 25, 2021

Study information

• Verified date: August 2021
• Source: Peking Union Medical College Hospital
• Contact: Xulei Cui, MD
• Phone: 13717739381
• Email: cui.xulei[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: November 25, 2021
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nerve Block

Intervention

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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The MEV90 of 0.5%Ropivacaine in Ultrasound-guided SASIS-FICBS	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.	up to 6 months