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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02084368
Other study ID # Nerve Block
Secondary ID
Status Completed
Phase Phase 4
First received March 6, 2014
Last updated September 10, 2014
Start date January 2014
Est. completion date February 2014

Study information

Verified date September 2014
Source Guangzhou General Hospital of Guangzhou Military Command
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

The research is to study the effectiveness and safety of combined lumbar plexus and sciatic nerve block by the guide of peripheral nerve stimulator (PNS) in unilateral knee replacement.There have be some papers which supported that combined lumbar plexus and sciatic nerve block may be more suitable for the old men.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

1. Patients of American Association of anesthetists(ASA)Grade 1?2 or 3

2. Aged between 18 and 85 years

3. Undergoing elective total knee replacement.

Exclusion Criteria:

1. Mental illness can not match

2. Nerve block, epidural anesthesia contraindicated

3. People who have Slow-type arrhythmias

4. History of chronic headaches and long-term use of analgesic drugs

5. People who were postoperative consciousness, language or hearing impaired

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Nerve block
Patients in this group were assigned to receive lumbar plexus block and sciatic nerve block both using 0.33% ropivacaine 30ml guided by PNS
Combined spinal and epidural anesthesia
Combined spinal and epidural anesthesia were performed in patients of this group with 0.5% hyperbaric bupivacaine 8~10mg at L2-3 or L3-4.
Drug:
Ropivacaine
Patients will be assigned to receive lumbar plexus block and sciatic nerve block both using 0.33% ropivacain 30ml guided by PNS.
Bupivacaine
Combined spinal and epidural anesthesia will be performed in patients with 0.5% hyperbaric bupivacaine 8~10mg.

Locations

Country Name City State
China Guangzhou Military Region General Hospital, Department of Anesthesiology Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Guangzhou General Hospital of Guangzhou Military Command

Country where clinical trial is conducted

China, 

References & Publications (2)

de Leeuw MA, Slagt C, Hoeksema M, Zuurmond WW, Perez RS. Hemodynamic changes during a combined psoas compartment-sciatic nerve block for elective orthopedic surgery. Anesth Analg. 2011 Mar;112(3):719-24. doi: 10.1213/ANE.0b013e318206bc30. Epub 2010 Dec 14 — View Citation

Farny J, Girard M, Drolet P. Posterior approach to the lumbar plexus combined with a sciatic nerve block using lidocaine. Can J Anaesth. 1994 Jun;41(6):486-91. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Maintenance time of sensory and motor nerve block from the end of injection of local anesthetic drug up to 24h after operation up to 24h after operation Yes
Secondary The change of hemodynamics the changes of SBP and DBP at 0, 5, 10, 20, 30, 60 min after injection 0, 5, 10, 20, 30, 60 min after injection Yes
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