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

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:

  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 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.

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

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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