Study of Nerve Block Anesthesia for Surgery of Hip Fracture in the Elderly
Primary Purpose
Anesthesia; Reaction
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
paravertebral nerve
lumbar and sacral plexus block
Sponsored by
About this trial
This is an interventional treatment trial for Anesthesia; Reaction
Eligibility Criteria
Inclusion Criteria:
- ASA Ⅰ-Ⅲ
- hip fracture need surgery
Exclusion Criteria:
- patient refusal
- chronic use of opioids
- coagulation disorders
- preexisting neurological disorders
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
paravertebral nerve
lumbar and sacral plexus block
Arm Description
Injection with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) , 10ml 0.5%ropivacaine at sacral plexus and 10ml 0.5%ropivacaine at paravertebral nerve(level L1)
a lumbar and sacral plexus block(LS) group with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) and 10ml 0.5%ropivacaine at sacral plexus;
Outcomes
Primary Outcome Measures
cumulative propofol dose
Secondary Outcome Measures
The optimal target concentration propofol
Full Information
NCT ID
NCT02104908
First Posted
March 3, 2014
Last Updated
December 30, 2014
Sponsor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02104908
Brief Title
Study of Nerve Block Anesthesia for Surgery of Hip Fracture in the Elderly
Official Title
Target-controlled Propofol Infusion as a Technique of Anesthesia for Surgery of Hip Fracture Under Ultrasound Guidance Lumbar and Sacral Plexus Block or Lumbar, Sacral and Paravertebral Nerve Block in the Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators aim to examine target-controlled propofol infusion as a technique of anesthesia for surgery of hip fracture under ultrasound guidance lumbar and sacral plexus block or lumbar, sacral and paravertebral nerve block in the elderly; and to evaluate which regional anesthesia was more sufficient for the old.
Detailed Description
Eighty patients with American Society of Anesthesiologists(ASA) Ⅰ-Ⅲ older than 80 years are randomly assigned to 2 groups: a lumbar and sacral plexus block(LS) group with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) and 10ml 0.5%ropivacaine at sacral plexus; a lumbar, sacral plexus and paravertebral nerve block(LSP) group with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) , 10ml 0.5%ropivacaine at sacral plexus and 10ml 0.5%ropivacaine at paravertebral nerve(level L1). The target-controlled propofol infusion is started immediately after positioning the patient on the operating table. The initial target concentration was 0.5μg/mL. The infusion rate is adjusted every 5min by increasing or decreasing the target concentration by 0.2μg/mL steps based on the patients' respiratory rate(RR), blood pressure(BP), heart rate(HR), and level of sedation(score of 5 on Ramsay Sedation Scale ). The minimal, maximal, optimal target concentration, cumulative propofol dose, frequency of spontaneous movement and incidences of associated complications are recorded. Patients were phoned for followup and questioned for activity status in one year. If the patients were dead, date of death; if they survived, daily living activity questioned.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia; Reaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
paravertebral nerve
Arm Type
Experimental
Arm Description
Injection with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) , 10ml 0.5%ropivacaine at sacral plexus and 10ml 0.5%ropivacaine at paravertebral nerve(level L1)
Arm Title
lumbar and sacral plexus block
Arm Type
Other
Arm Description
a lumbar and sacral plexus block(LS) group with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) and 10ml 0.5%ropivacaine at sacral plexus;
Intervention Type
Procedure
Intervention Name(s)
paravertebral nerve
Intervention Description
a lumbar, sacral plexus and paravertebral nerve block(LSP) group with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) , 10ml 0.5%ropivacaine at sacral plexus and 10ml 0.5%ropivacaine at paravertebral nerve(level L1).
Intervention Type
Procedure
Intervention Name(s)
lumbar and sacral plexus block
Intervention Description
a lumbar and sacral plexus block(LS) group with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) and 10ml 0.5%ropivacaine at sacral plexus;
Primary Outcome Measure Information:
Title
cumulative propofol dose
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
The optimal target concentration propofol
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Mortality
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA Ⅰ-Ⅲ
hip fracture need surgery
Exclusion Criteria:
patient refusal
chronic use of opioids
coagulation disorders
preexisting neurological disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daqiang Zhao, Master
Organizational Affiliation
Shanghai Jiaotong University Affiliated Sixth People's Hospital Shanghai,China
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Study of Nerve Block Anesthesia for Surgery of Hip Fracture in the Elderly
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