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

Anesthesia; Reaction Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02104908
• Other study ID #: PARA-2014
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: March 3, 2014
• Last updated: December 30, 2014
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2014
• Source: Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 80 Years and older

Eligibility

Inclusion Criteria:

• ASA ?-?

• hip fracture need surgery

Exclusion Criteria:

• patient refusal

• chronic use of opioids

• coagulation disorders

• preexisting neurological disorders

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia; Reaction
• Hip Fractures

Intervention

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;

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University Affiliated Sixth People’s Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality		1 year	Yes
Primary	cumulative propofol dose		24 weeks	Yes
Secondary	The optimal target concentration propofol		24 weeks	Yes