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

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ClinicalTrials.gov Identifier: NCT02104908
Recruitment Status : Unknown
Verified January 2014 by Daqiang Zhao, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : April 7, 2014
Last Update Posted : December 31, 2014
Sponsor:
Information provided by (Responsible Party):
Daqiang Zhao, 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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2014
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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).

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;




Primary Outcome Measures :
  1. cumulative propofol dose [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. The optimal target concentration propofol [ Time Frame: 24 weeks ]

Other Outcome Measures:
  1. Mortality [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA Ⅰ-Ⅲ
  • hip fracture need surgery

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104908


Sponsors and Collaborators
Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
Investigators
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Principal Investigator: Daqiang Zhao, Master Shanghai Jiaotong University Affiliated Sixth People's Hospital Shanghai,China

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Responsible Party: Daqiang Zhao, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
ClinicalTrials.gov Identifier: NCT02104908    
Other Study ID Numbers: PARA-2014
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Ropivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents