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Clinical Trials/NCT02635763
NCT02635763UnknownNot Applicable

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

Shanghai Jiao Tong University Affiliated Sixth People's Hospital1 site in 1 country60 target enrollmentStarted: October 1, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
postoperative quality of recovery

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to 85 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

postoperative quality of recovery

Time Frame: 3 days after operative

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Qingfu Zhang

Shanghaii Sixth People's Hospital

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Study Sites (1)

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