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

NCT05012137 | Unknown

• 1 other identifier: SASIS-FICB
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Nerve Block

Keywords

Minimum Effective volume; Ropivacaine; Fascia Iliaca Compartment Block

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

SASIS-FICB

EXPERIMENTAL

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)

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

Interventions

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

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

SASIS-FICB

different volume of 0.5% ropivacaine 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

SASIS-FICB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing hip/knee surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Yuguang Huang, MD

  Director of Anesthesiology Department,Peking Union Medical College Hospital

  STUDY CHAIR

Central Study Contacts

Xulei Cui, MD

CONTACT

13717739381; cui.xulei@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a dosing exploratory study.

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 19, 2021
• Study Start: August 25, 2021
• Primary Completion: October 25, 2021
• Study Completion: November 25, 2021
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)