NCT02104908

Brief Summary

The investigators aim to examine target-controlled propofol infusion as a technique of anesthesia for surgery of hip fracture under ultrasound guidance lumbar and sacral plexus block or lumbar, sacral and paravertebral nerve block in the elderly; and to evaluate which regional anesthesia was more sufficient for the old.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_4

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 7, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 31, 2014

Status Verified

January 1, 2014

Enrollment Period

9 months

First QC Date

March 3, 2014

Last Update Submit

December 30, 2014

Conditions

Anesthesia; Reaction

Outcome Measures

Primary Outcomes (1)

  • cumulative propofol dose

    24 weeks

Secondary Outcomes (1)

  • The optimal target concentration propofol

    24 weeks

Other Outcomes (1)

  • Mortality

    1 year

Study Arms (2)

paravertebral nerve

EXPERIMENTAL

Injection with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) , 10ml 0.5%ropivacaine at sacral plexus and 10ml 0.5%ropivacaine at paravertebral nerve(level L1)

Procedure: paravertebral nerve

lumbar and sacral plexus block

OTHER

a lumbar and sacral plexus block(LS) group with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) and 10ml 0.5%ropivacaine at sacral plexus;

Procedure: lumbar and sacral plexus block

Interventions

paravertebral nervePROCEDURE

a lumbar, sacral plexus and paravertebral nerve block(LSP) group with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) , 10ml 0.5%ropivacaine at sacral plexus and 10ml 0.5%ropivacaine at paravertebral nerve(level L1).

paravertebral nerve
lumbar and sacral plexus blockPROCEDURE

a lumbar and sacral plexus block(LS) group with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) and 10ml 0.5%ropivacaine at sacral plexus;

lumbar and sacral plexus block

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • ASA Ⅰ-Ⅲ
  • hip fracture need surgery

You may not qualify if:

  • patient refusal
  • chronic use of opioids
  • coagulation disorders
  • preexisting neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Daqiang Zhao, Master

    Shanghai Jiaotong University Affiliated Sixth People's Hospital Shanghai,China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Daqiang Zhao

Study Record Dates

First Submitted

March 3, 2014

First Posted

April 7, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 31, 2014

Record last verified: 2014-01