NCT02635763

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 21, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

December 21, 2015

Status Verified

December 1, 2015

Enrollment Period

2 months

First QC Date

December 17, 2015

Last Update Submit

December 18, 2015

Conditions

Hip Fracture

Keywords

nerve blockgeneral anesthesiahip fracturerecovery

Outcome Measures

Primary Outcomes (1)

  • postoperative quality of recovery

    3 days after operative

Study Arms (2)

PNBs1

OTHER

Femoral nerve and the lateral cutaneous nerve block combined with general anesthesia

Procedure: Femoral nerve and the lateral cutaneous nerve block

PNBs2

OTHER

Lumbar plexus and sacral plexus nerve block combined with general anesthesia

Procedure: Lumbar plexus and sacral plexus nerve block

Interventions

Femoral nerve and the lateral cutaneous nerve blockPROCEDURE

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

PNBs1
Lumbar plexus and sacral plexus nerve blockPROCEDURE

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

PNBs2

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Jiao Tong University Affiliated Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 10823094BACKGROUND

  • 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.

    PMID: 21844549BACKGROUND

  • 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.

    PMID: 24600214BACKGROUND

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Junfeng Zhang, PhD

    Department of Anesthesiology, Shanghai Jiao Tong University Affiliated Shanghai Sixth People's Hospital

    STUDY DIRECTOR

Central Study Contacts

Qingfu Zhang, master

CONTACT

86-18930173672zhangqingfu1228@163.com

Junfeng Zhang, PhD

CONTACT

86-18930173672zhangjunfeng@sjtu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Shanghaii Sixth People's Hospital

Study Record Dates

First Submitted

December 17, 2015

First Posted

December 21, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

December 21, 2015

Record last verified: 2015-12

Locations

CN(1)