- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02635763
Peripheral Nerve Blocks in Elderly Patients With Hip Fracture
December 18, 2015 updated by: Qingfu Zhang, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
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
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.
Study Overview
Status
Unknown
Conditions
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.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200233
- Recruiting
- Shanghai Jiao Tong University Affiliated Shanghai Sixth People's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 85 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: PNBs1
Femoral nerve and the lateral cutaneous nerve block combined with general anesthesia
|
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
|
|
Other: PNBs2
Lumbar plexus and sacral plexus nerve block combined with general anesthesia
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
postoperative quality of recovery
Time Frame: 3 days after operative
|
3 days after operative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Junfeng Zhang, PhD, Department of Anesthesiology, Shanghai Jiao Tong University Affiliated Shanghai Sixth People's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
June 1, 2016
Study Registration Dates
First Submitted
December 17, 2015
First Submitted That Met QC Criteria
December 18, 2015
First Posted (Estimate)
December 21, 2015
Study Record Updates
Last Update Posted (Estimate)
December 21, 2015
Last Update Submitted That Met QC Criteria
December 18, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NB001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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