Study of Nerve Block Anesthesia for Surgery of Hip Fracture in the Elderly

Sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02104908

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia; Reaction	Procedure: paravertebral nerve Procedure: lumbar and sacral plexus block	Phase 4

Detailed Description

Eighty patients with American Society of Anesthesiologists（ASA） Ⅰ-Ⅲ older than 80 years are randomly assigned to 2 groups: 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; 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). The target-controlled propofol infusion is started immediately after positioning the patient on the operating table. The initial target concentration was 0.5μg/mL. The infusion rate is adjusted every 5min by increasing or decreasing the target concentration by 0.2μg/mL steps based on the patients' respiratory rate(RR), blood pressure(BP), heart rate(HR), and level of sedation(score of 5 on Ramsay Sedation Scale ). The minimal, maximal, optimal target concentration, cumulative propofol dose, frequency of spontaneous movement and incidences of associated complications are recorded. Patients were phoned for followup and questioned for activity status in one year. If the patients were dead, date of death; if they survived, daily living activity questioned.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2014

Anticipated Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: paravertebral nerve 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 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).
Other: lumbar and sacral plexus block 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 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;

Arm

Intervention/Treatment

Experimental: paravertebral nerve

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

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).

Other: lumbar and sacral plexus block

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

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;

Outcome Measures

Primary Outcome Measures

cumulative propofol dose [24 weeks]

Secondary Outcome Measures

The optimal target concentration propofol [24 weeks]

Other Outcome Measures

Mortality [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

80 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

ASA Ⅰ-Ⅲ
hip fracture need surgery

Exclusion Criteria:

patient refusal
chronic use of opioids
coagulation disorders
preexisting neurological disorders

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Investigators

Principal Investigator: Daqiang Zhao, Master, Shanghai Jiaotong University Affiliated Sixth People's Hospital Shanghai,China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daqiang Zhao, Daqiang Zhao, Shanghai Jiao Tong University Affiliated Sixth People's Hospital

ClinicalTrials.gov Identifier:

NCT02104908

Other Study ID Numbers:

PARA-2014

First Posted:

Apr 7, 2014

Last Update Posted:

Dec 31, 2014

Last Verified:

Jan 1, 2014

Additional relevant MeSH terms:

Hip Fractures

Study Results

No Results Posted as of Dec 31, 2014