MED90 of Ropivacaine for Peripheral Nerve Block on Posture-evoked Pain in Spinal Anesthesia Positioning
Primary Purpose
Hip Fractures
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fascia iliaca block
Femoral nerve block
Pericapsular nerve group block (PENG block)
Sponsored by
About this trial
This is an interventional prevention trial for Hip Fractures
Eligibility Criteria
Inclusion Criteria:
- Age 65 - 85 years
- American Society of Anesthesiologists physical statusⅠ- Ⅲ
- Patients will receive hip replacement
Exclusion Criteria:
- 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
Sites / Locations
- Department of Anesthesiology, Tongji HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Fascia iliaca block
Femoral nerve block
Pericapsular nerve group block (PENG block)
Arm Description
ultrasound-guided fascia iliaca block with predetermined dose of 0.4% ropivacaine will be performed.
ultrasound-guided ultrasound-guided femoral nerve block with predetermined dose of 0.4% ropivacaine will be performed.
ultrasound-guided ultrasound-guided pericapsular nerve group block with predetermined dose of 0.4% ropivacaine will be performed.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04705974
First Posted
January 9, 2021
Last Updated
January 25, 2022
Sponsor
Huazhong University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT04705974
Brief Title
MED90 of Ropivacaine for Peripheral Nerve Block on Posture-evoked Pain in Spinal Anesthesia Positioning
Official Title
Minimum Effective Dose of Ropivacaine for Peripheral Nerve Block on Posture-evoked Pain for Spinal Anesthesia in Patients With Hip Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2022 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 = 0.11, or the same dose, with a probability of 1 - b = 0.89. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fascia iliaca block
Arm Type
Experimental
Arm Description
ultrasound-guided fascia iliaca block with predetermined dose of 0.4% ropivacaine will be performed.
Arm Title
Femoral nerve block
Arm Type
Experimental
Arm Description
ultrasound-guided ultrasound-guided femoral nerve block with predetermined dose of 0.4% ropivacaine will be performed.
Arm Title
Pericapsular nerve group block (PENG block)
Arm Type
Experimental
Arm Description
ultrasound-guided ultrasound-guided pericapsular nerve group block with predetermined dose of 0.4% ropivacaine will be performed.
Intervention Type
Procedure
Intervention Name(s)
Fascia iliaca block
Intervention Description
Fascia iliaca block will be performed under ultrasound guidenance.
Intervention Type
Procedure
Intervention Name(s)
Femoral nerve block
Intervention Description
Femoral nerve block will be performed under ultrasound guidenance.
Intervention Type
Procedure
Intervention Name(s)
Pericapsular nerve group block (PENG block)
Intervention Description
Pericapsular nerve group block (PENG block) will be performed under ultrasound guidenance.
Primary Outcome Measure Information:
Title
The minimum effective dose of ropivacaine in three types of nerve block for analgesia for spinal anesthesia positioning in patients with hip fractures
Description
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.
Time Frame
up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 65 - 85 years
American Society of Anesthesiologists physical statusⅠ- Ⅲ
Patients will receive hip replacement
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Liu, Dr.
Phone
+86-15007124668
Email
hosp1yong@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Mei, Dr.
Phone
+86-13006162508
Email
wmei@hust.edu.cn
Facility Information:
Facility Name
Department of Anesthesiology, Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Mei, Dr.
Phone
+86-13006162508
Email
wmei@hust.edu.cn
First Name & Middle Initial & Last Name & Degree
Yong Liu, Dr.
Phone
+86-15007124668
Email
hosp1yong@163.com
First Name & Middle Initial & Last Name & Degree
Wei Mei
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MED90 of Ropivacaine for Peripheral Nerve Block on Posture-evoked Pain in Spinal Anesthesia Positioning
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