Nerve Block
Conditions
Keywords
Minimum Effective volume, Ropivacaine, Fascia Iliaca Compartment Block
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.
Interventions
PROCEDUREUltrasound-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)
DRUGdifferent 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
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a dosing exploratory study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactXulei Cui, MD
Outcome results
None listed