Peripheral Nerve Blocks in Elderly Patients With Hip Fracture

Hip Fracture Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02635763
• Other study ID #: NB001
• Status: Recruiting
• Phase: N/A
• First received: December 17, 2015
• Last updated: December 18, 2015
• Start date: October 2015
• Est. completion date: June 2016

Study information

• Verified date: December 2015
• Source: Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
• Contact: Qingfu Zhang, master
• Phone: 86-18930173672
• Email: zhangqingfu1228[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

1. ASA grade I ~ III level;

2. The BMI <30;

3. The Mini - getting the state examination MMSE > 23;

4. The operation type:open reduction and internal fixation or bipolar head replace.

Exclusion Criteria:

1. Serious systemic diseases such as respiratory dysfunction, cardiac insufficiency, and renal insufficiency;

2. Has a history of cognitive function disorder or mental illness;

3. Has a history of cerebral infarction and leave sequela;

4. The blood coagulation dysfunction;

5. The hearing or visual impairment;

6. Unable to complete assessment;

7. Operation time more than 90 minutes;

8. The bleeding is greater than 1000 ml.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

Procedure:
• Femoral nerve and the lateral cutaneous nerve block
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 block
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

Locations

Country	Name	City	State
China	Shanghai Jiao Tong University Affiliated Shanghai Sixth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University Affiliated Sixth People’s Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. Erratum in: Br J Anaesth 2002 Apr;88(4):619. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative quality of recovery		3 days after operative	No