Application of Combined Lumbar Plexus and Sciatic Nerve Block

Study Overview
=================
Brief 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.

Official Title
-----------------
Application of Combined Lumbar Plexus and Sciatic Nerve Block in Unilateral Knee Replacement

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Procedure: Nerve block
* Procedure: Combined spinal and epidural anesthesia
* Drug: Ropivacaine
* Drug: Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of American Association of anesthetists（ASA）Grade 1、2 or 3 Aged between 18 and 85 years Undergoing elective total knee replacement. Exclusion Criteria: Mental illness can not match Nerve block, epidural anesthesia contraindicated People who have Slow-type arrhythmias History of chronic headaches and long-term use of analgesic drugs People who were postoperative consciousness, language or hearing impaired

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nerve block<br>Patients in this group were assigned to receive lumbar plexus block and sciatic nerve block guided by PNS. | Procedure: Nerve block<br>* Patients in this group were assigned to receive lumbar plexus block and sciatic nerve block both using 0.33% ropivacaine 30ml guided by PNS<br>Drug: Ropivacaine<br>* Patients will be assigned to receive lumbar plexus block and sciatic nerve block both using 0.33% ropivacain 30ml guided by PNS.<br>* Other names: 0.33%Ropivacaine;|
| Placebo Comparator: combined spinal and epidural anesthesia<br>Combined spinal and epidural anesthesia were performed in patients of this group. | Procedure: Combined spinal and epidural anesthesia<br>* 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.<br>Drug: Bupivacaine<br>* Combined spinal and epidural anesthesia will be performed in patients with 0.5% hyperbaric bupivacaine 8 10mg.<br>* Other names: 0.5%Bupivacaine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
combined lumbar plexus and sciatic nerve block，, combined spinal and epidural anesthesia