Hip FractureNCT02635763
Peripheral Nerve Blocks in Elderly Patients With Hip Fracture
A study testing Femoral nerve and the lateral cutaneous nerve block and Lumbar plexus and sacral plexus nerve block in people with Hip Fracture, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Femoral nerve and the lateral cutaneous nerve block and Lumbar plexus and sacral plexus nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Jiao Tong University Affiliated Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
About this study
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
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.
Read the 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.
- Conditions
- Hip Fracture
- Being tested
- Femoral nerve and the lateral cutaneous nerve block, Lumbar plexus and sacral plexus nerve block
- Keywords
- nerve block, general anesthesia, hip fracture, recovery
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral nerve and the lateral cutaneous nerve blockProcedure or surgery
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
Lumbar plexus and sacral plexus nerve blockProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| PNBs1 | Other | Femoral nerve and the lateral cutaneous nerve block combined with general anesthesia Receives: Procedure: Femoral nerve and the lateral cutaneous nerve block |
| PNBs2 | Other | Lumbar plexus and sacral plexus nerve block combined with general anesthesia Receives: Procedure: Lumbar plexus and sacral plexus nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative quality of recovery
Measured: 3 days after operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingfu Zhang, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Investigators
- Junfeng Zhang, PhD, Study director, Department of Anesthesiology, Shanghai Jiao Tong University Affiliated Shanghai Sixth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635763
- Sponsor's protocol ID
- NB001
- Status last verified
- Dec 2015
- First submitted
- 17 Dec 2015
- Last updated
- 21 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 10823094Abou-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.
PubMed 21844549Liu 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.
PubMed 24600214
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02635763
- Acronym / sponsor ID
- NB001
- Conditions
- Hip Fracture
- Keywords
- nerve block, general anesthesia, hip fracture, recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 21 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNBs1 | Other | Procedure: Femoral nerve and the lateral cutaneous nerve blockFemoral nerve and the lateral cutaneous nerve block combined with general anesthesia |
| PNBs2 | Other | Procedure: Lumbar plexus and sacral plexus nerve blockLumbar plexus and sacral plexus nerve block combined with general anesthesia |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Femoral nerve and the lateral cutaneous nerve blockFemoral 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 | Procedure or surgery | PNBs1 |
| Lumbar plexus and sacral plexus nerve blockLumbar 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 | Procedure or surgery | PNBs2 |
Primary outcome
postoperative quality of recovery
Time frame: 3 days after operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2015.
- Background: PubMed 10823094Urwin 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.
- Background: PubMed 21844549Abou-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.
- Background: PubMed 24600214Liu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junfeng Zhang, PhD study director
Department of Anesthesiology, Shanghai Jiao Tong University Affiliated Shanghai Sixth People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral nerve and the lateral cutaneous nerve block and Lumbar plexus and sacral plexus nerve block in people with Hip Fracture, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qingfu Zhang, master (86-18930173672, zhangqingfu1228@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative quality of recovery (time frame: 3 days after operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02635763, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2015.