- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02104908
Study of Nerve Block Anesthesia for Surgery of Hip Fracture in the Elderly
December 30, 2014 updated by: Daqiang Zhao, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
80 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASA Ⅰ-Ⅲ
- hip fracture need surgery
Exclusion Criteria:
- patient refusal
- chronic use of opioids
- coagulation disorders
- preexisting neurological disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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)
|
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;
|
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;
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
cumulative propofol dose
Time Frame: 24 weeks
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The optimal target concentration propofol
Time Frame: 24 weeks
|
24 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mortality
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Daqiang Zhao, Master, Shanghai Jiaotong University Affiliated Sixth People's Hospital Shanghai,China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Anticipated)
December 1, 2014
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
March 3, 2014
First Submitted That Met QC Criteria
April 2, 2014
First Posted (Estimate)
April 7, 2014
Study Record Updates
Last Update Posted (Estimate)
December 31, 2014
Last Update Submitted That Met QC Criteria
December 30, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PARA-2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anesthesia; Reaction
-
University of Texas Southwestern Medical CenterRecruitingAnesthesia | Anesthesia; Reaction | Anesthesia Complication | Anesthesia; Adverse Effect | Propofol Adverse Reaction | Etomidate Adverse ReactionUnited States
-
Universitas Sebelas MaretIndonesia Endowment Fund for EducationNot yet recruitingAnesthesia | Anesthesia; Reaction
-
Indonesia UniversityActive, not recruitingAnesthesia | Anesthesia; ReactionIndonesia
-
Matthew BorzageRecruitingAnesthesia | Anesthesia; ReactionUnited States
-
Taipei Veterans General Hospital, TaiwanRecruiting
-
Tamer Nabil AbdelrahmanCompletedAnesthesia; ReactionEgypt
-
Yuzuncu Yıl UniversityCompletedAnesthesia; ReactionTurkey
-
University Hospital Schleswig-HolsteinCompleted
-
Universidad de CartagenaCompletedAnesthesia; Reaction
-
Shanghai Jiao Tong University Affiliated Sixth...Unknown
Clinical Trials on paravertebral nerve
-
University of PittsburghCompletedTotal Hip ArthroplastyUnited States
-
Charles LukeCompletedThoracic Surgical ProceduresUnited States
-
Jianghui XuCompleted
-
University of North Carolina, Chapel HillCompletedRegional Anesthesia SuccessUnited States
-
Memorial Medical CenterU.S. Army Medical Research and Development Command; Henry M. Jackson Foundation...Terminated
-
Lawson Health Research InstituteSt. Joseph's Health Care LondonCompleted
-
Spectrum Health HospitalsTerminated
-
Taipei Veterans General Hospital, TaiwanNational Yang Ming UniversityRecruitingPain, Postoperative | Ultrasound Therapy; Complications | Acute Post-thoracotomy Pain | Thorax; Pain, Spine, With Radicular and Visceral PainTaiwan
-
Peking University First HospitalRecruitingAnalgesia | Paravertebral Block | Regional Block | Local AnestheticsChina