Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04705974
Status:
UNKNOWN
Last Update Posted:
2022-02-09
First Post:
2021-01-09
Brief Title:
MED90 of Ropivacaine for Peripheral Nerve Block on Posture-evoked Pain in Spinal Anesthesia Positioning
Sponsor:
Huazhong University of Science and Technology
Organization:
Huazhong University of Science and Technology
Study Overview
Official Title:
Minimum Effective Dose of Ropivacaine for Peripheral Nerve Block on Posture-evoked Pain for Spinal Anesthesia in Patients With Hip Fracture
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Patients with hip fractures are anticipated to endure sever pain caused by positional changes required for spinal anesthesia Providing analgesia before positioning not only increases patient comfort but also improves positioning and successful spinal block Peripheral nerve block is an effective strategy for relieving pain during postures change for spinal anesthesia in patients with hip fractures Three types of peripheral nerve block including fascia iliaca block femoral nerve block and Pericapsular nerve group block PENG block has been successfully used for analgesia for spinal anesthesia positioning in patients with hip fractures However the minimum effective dose of local anesthetics for these three types of peripheral nerve block is not known This study aims to determine the minimum effective dose of ropovacaine in the three types of peripheral nerve block using a biased coin design up-and-down sequential method Successful block is defined as NRS score 3 by positional changes for spinal anesthesia achieved at 20min after the block MED90 of ropivacaine for fascia iliaca block femoral nerve block and PENG block be assessed respectively Patients will receive ultrasound guided peripheral nerve block The initial dose is chosen as 80 mg on the basis of clinical experience Subsequently if a patient has an inadequate block the ropivacaine dose is increased by 8 mg in the next subject If a patient has a successful block the next subject is randomized to receive either a lower dose with a decrement of 8 mg with a probability of b 011 or the same dose with a probability of 1 - b 089 Forty five successful blocks for each type of nerve block will be accomplished MED90 of each type of nerve block will be calculated by isotonic regression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None