Back to resultsPeripheral Nerve Blocks in Elderly Patients With Hip Fracture
Primary Purpose
Hip Fracture
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Femoral nerve and the lateral cutaneous nerve block
Lumbar plexus and sacral plexus nerve block
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fracture focused on measuring nerve block, general anesthesia, hip fracture, recovery
Eligibility Criteria
Inclusion Criteria:
- ASA grade I ~ III level;
- The BMI <30;
- The Mini - getting the state examination MMSE > 23;
- The operation type:open reduction and internal fixation or bipolar head replace.
Exclusion Criteria:
- Serious systemic diseases such as respiratory dysfunction, cardiac insufficiency, and renal insufficiency;
- Has a history of cognitive function disorder or mental illness;
- Has a history of cerebral infarction and leave sequela;
- The blood coagulation dysfunction;
- The hearing or visual impairment;
- Unable to complete assessment;
- Operation time more than 90 minutes;
- The bleeding is greater than 1000 ml.
Sites / Locations
- Shanghai Jiao Tong University Affiliated Shanghai Sixth People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
PNBs1
PNBs2
Arm Description
Femoral nerve and the lateral cutaneous nerve block combined with general anesthesia
Lumbar plexus and sacral plexus nerve block combined with general anesthesia
Outcomes
Primary Outcome Measures
postoperative quality of recovery
Secondary Outcome Measures
Full Information
NCT ID
NCT02635763
First Posted
December 17, 2015
Last Updated
December 18, 2015
Sponsor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02635763
Brief Title
Peripheral Nerve Blocks in Elderly Patients With Hip Fracture
Official Title
A Randomized Controlled Trial of Comparing Two Methods of Nerve Block in Combination With Laryngeal Mask Anesthesia Effect for Hip Fracture on Post-operative Quality of Recovery in Elderly Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
June 2016 (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
No
5. Study Description
Brief Summary
As the population ages, the frequency of surgery is increasing proportionally, bringing with it the challenge of managing older patients with frequent comorbid diseases and an increased risk of complications. Poor postoperative quality of recovery may result in patient and family suffering, a prolonged hospital stay, and a greater demand on health care resources.The purpose of this study was to evaluate the ultrasound guided percutaneous femoral nerve+lateral cutaneous nerve versus lumbar plexus+sacral plexus nerve block composite laryngeal mask anesthesia in elderly hip fracture surgery, the application of assessing their impact on the postoperative recovery quality.
Detailed Description
In this study, patients who were more than 65 years old with hip fracture were randomized to peripheral nerve blocks 1(PNBs1)- femoral nerve+lateral cutaneous nerve-with laryngeal mask anesthesia, or peripheral nerve blocks 2(PNBs2) - lumbar plexus and sciatic - with laryngeal mask anesthesia. Blocks were performed using ultrasound and 0.5% ropivacaine. All patients received postoperative multimodal analgesia. Postoperative recovery was assessed at 15 minutes, 40 minutes,- 1 day, 3 days, and 7 days after surgery, with the Postoperative Quality of Recovery Scale, in physiological, nociceptive, emotive, modified activities of daily living, modified cognitive, and overall patient perspective domains.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture
Keywords
nerve block, general anesthesia, hip fracture, recovery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PNBs1
Arm Type
Other
Arm Description
Femoral nerve and the lateral cutaneous nerve block combined with general anesthesia
Arm Title
PNBs2
Arm Type
Other
Arm Description
Lumbar plexus and sacral plexus nerve block combined with general anesthesia
Intervention Type
Procedure
Intervention Name(s)
Femoral nerve and the lateral cutaneous nerve block
Intervention Description
Femoral nerve block was performed using 0.5% ropivacaine (15ml) under ultrasound guide;the lateral cutaneous nerve block was performed using 0.5% ropivacaine (5ml) under ultrasound guide
Intervention Type
Procedure
Intervention Name(s)
Lumbar plexus and sacral plexus nerve block
Intervention Description
Lumbar plexus block was performed using 0.5% ropivacaine (25ml) under ultrasound guide; sacral plexus nerve block was performed using 0.5% ropivacaine (15ml) under ultrasound guide
Primary Outcome Measure Information:
Title
postoperative quality of recovery
Time Frame
3 days after operative
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:
ASA grade I ~ III level;
The BMI <30;
The Mini - getting the state examination MMSE > 23;
The operation type:open reduction and internal fixation or bipolar head replace.
Exclusion Criteria:
Serious systemic diseases such as respiratory dysfunction, cardiac insufficiency, and renal insufficiency;
Has a history of cognitive function disorder or mental illness;
Has a history of cerebral infarction and leave sequela;
The blood coagulation dysfunction;
The hearing or visual impairment;
Unable to complete assessment;
Operation time more than 90 minutes;
The bleeding is greater than 1000 ml.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qingfu Zhang, master
Phone
86-18930173672
Email
zhangqingfu1228@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Junfeng Zhang, PhD
Phone
86-18930173672
Email
zhangjunfeng@sjtu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junfeng Zhang, PhD
Organizational Affiliation
Department of Anesthesiology, Shanghai Jiao Tong University Affiliated Shanghai Sixth People's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Jiao Tong University Affiliated Shanghai Sixth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200233
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
10823094
Citation
Urwin SC, Parker MJ, Griffiths R. General versus regional anaesthesia for hip fracture surgery: a meta-analysis of randomized trials. Br J Anaesth. 2000 Apr;84(4):450-5. doi: 10.1093/oxfordjournals.bja.a013468. Erratum In: Br J Anaesth 2002 Apr;88(4):619.
Results Reference
background
PubMed Identifier
21844549
Citation
Abou-Setta AM, Beaupre LA, Rashiq S, Dryden DM, Hamm MP, Sadowski CA, Menon MR, Majumdar SR, Wilson DM, Karkhaneh M, Mousavi SS, Wong K, Tjosvold L, Jones CA. Comparative effectiveness of pain management interventions for hip fracture: a systematic review. Ann Intern Med. 2011 Aug 16;155(4):234-45. doi: 10.7326/0003-4819-155-4-201108160-00346.
Results Reference
background
PubMed Identifier
24600214
Citation
Liu J, Yuan W, Wang X, Royse CF, Gong M, Zhao Y, Zhang H. Peripheral nerve blocks versus general anesthesia for total knee replacement in elderly patients on the postoperative quality of recovery. Clin Interv Aging. 2014 Feb 18;9:341-50. doi: 10.2147/CIA.S56116. eCollection 2014.
Results Reference
background
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Peripheral Nerve Blocks in Elderly Patients With Hip Fracture
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