MED90 of Ropivacaine for Peripheral Nerve Block on Posture-evoked Pain in Spinal Anesthesia Positioning
Minimum Effective Dose of Ropivacaine for Peripheral Nerve Block on Posture-evoked Pain for Spinal Anesthesia in Patients With Hip Fracture
1 other identifier
interventional
180
1 country
1
Brief Summary
This study aims to determine the minimum effective dose of ropivacaine for peripheral nerve block on posture-evoked pain for spinal anesthesia in elderly patients with hip fracture. Three types of peripheral nerve block, including fascia iliaca block, femoral nerve block and Pericapsular nerve group block (PENG block) will be assessed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2021
CompletedFirst Posted
Study publicly available on registry
January 12, 2021
CompletedStudy Start
First participant enrolled
January 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2024
CompletedFebruary 9, 2022
January 1, 2022
2.3 years
January 9, 2021
January 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The minimum effective dose of ropivacaine in three types of nerve block for analgesia for spinal anesthesia positioning in patients with hip fractures
The minimum effective dose of ropivacaine in each type of nerve block is based on 45 patients with satisfactory analgesia during positioning for spinal anesthesia.
up to 24 months
Study Arms (3)
Fascia iliaca block
EXPERIMENTALultrasound-guided fascia iliaca block with predetermined dose of 0.4% ropivacaine will be performed.
Femoral nerve block
EXPERIMENTALultrasound-guided ultrasound-guided femoral nerve block with predetermined dose of 0.4% ropivacaine will be performed.
Pericapsular nerve group block (PENG block)
EXPERIMENTALultrasound-guided ultrasound-guided pericapsular nerve group block with predetermined dose of 0.4% ropivacaine will be performed.
Interventions
Fascia iliaca block will be performed under ultrasound guidenance.
Femoral nerve block will be performed under ultrasound guidenance.
Pericapsular nerve group block (PENG block) will be performed under ultrasound guidenance.
Eligibility Criteria
You may qualify if:
- Age 65 - 85 years
- American Society of Anesthesiologists physical statusⅠ- Ⅲ
- Patients will receive hip replacement
You may not qualify if:
- Patient refusal
- Cognitive impairment(NRS pain score cannot be assessed)
- Peripheral neuropathy
- Mutiple furacture
- skin infection at the site of injection
- allergy to ropivacaine、lidocaine or bupivacaine
- contraindication to spinal anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology, Tongji Hospital
Wuhan, Hubei, 430060, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 9, 2021
First Posted
January 12, 2021
Study Start
January 25, 2022
Primary Completion
May 1, 2024
Study Completion
May 15, 2024
Last Updated
February 9, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share