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

Phase 4

• Conditions: Anesthesia; Reaction
• Interventions: Procedure: lumbar and sacral plexus block; Procedure: paravertebral nerve

• Registration Number: NCT02104908
• Lead Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital

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.

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 Timeline

• Status Verified: 2014-01
• Study Start: 2014-03
• Study First Submitted: 2014-03-03
• Study First Submitted QC: 2014-04-02
• Study First Posted: 2014-04-07
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-30
• Last Update Posted: 2014-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• ASA Ⅰ-Ⅲ
• hip fracture need surgery

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lumbar and sacral plexus block	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;
paravertebral nerve	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)

Primary Outcome Measures

Name	Time	Method
cumulative propofol dose	24 weeks

Secondary Outcome Measures

Name	Time	Method
The optimal target concentration propofol	24 weeks