Application of Combined Lumbar Plexus and Sciatic Nerve Block

September 10, 2014 updated by: bo xu, Guangzhou General Hospital of Guangzhou Military Command

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510010
        • Guangzhou Military Region General Hospital, Department of Anesthesiology

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nerve block
Patients in this group were assigned to receive lumbar plexus block and sciatic nerve block guided by PNS.
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
Drug: Ropivacaine
Patients will be assigned to receive lumbar plexus block and sciatic nerve block both using 0.33% ropivacain 30ml guided by PNS.
Other Names:
  • 0.33%Ropivacaine
Placebo Comparator: combined spinal and epidural anesthesia
Combined spinal and epidural anesthesia were performed in patients of this group.
Procedure: 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: Bupivacaine
Combined spinal and epidural anesthesia will be performed in patients with 0.5% hyperbaric bupivacaine 8~10mg.
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
Time Frame: up to 24h after operation
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
Time Frame: 0, 5, 10, 20, 30, 60 min after injection
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou General Hospital of Guangzhou Military Command

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2014

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

March 6, 2014

First Submitted That Met QC Criteria

March 10, 2014

First Posted (Estimate)

March 12, 2014

Study Record Updates

Last Update Posted (Estimate)

September 11, 2014

Last Update Submitted That Met QC Criteria

September 10, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nerve Block

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.

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