NCT02084368

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 6, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
Last Updated

September 11, 2014

Status Verified

September 1, 2014

Enrollment Period

1 month

First QC Date

March 6, 2014

Last Update Submit

September 10, 2014

Conditions

Anesthesia

Keywords

combined lumbar plexus and sciatic nerve block，combined spinal and epidural anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The change of hemodynamics

    0, 5, 10, 20, 30, 60 min after injection

Study Arms (2)

Nerve block

EXPERIMENTAL

Patients in this group were assigned to receive lumbar plexus block and sciatic nerve block guided by PNS.

Procedure: Nerve blockDrug: Ropivacaine

combined spinal and epidural anesthesia

PLACEBO COMPARATOR

Combined spinal and epidural anesthesia were performed in patients of this group.

Procedure: Combined spinal and epidural anesthesiaDrug: Bupivacaine

Interventions

Nerve blockPROCEDURE

Patients in this group were assigned to receive lumbar plexus block and sciatic nerve block both using 0.33% ropivacaine 30ml guided by PNS

Nerve block
Combined spinal and epidural anesthesiaPROCEDURE

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.

combined spinal and epidural anesthesia
RopivacaineDRUG

Patients will be assigned to receive lumbar plexus block and sciatic nerve block both using 0.33% ropivacain 30ml guided by PNS.

Also known as: 0.33%Ropivacaine
Nerve block
BupivacaineDRUG

Combined spinal and epidural anesthesia will be performed in patients with 0.5% hyperbaric bupivacaine 8\~10mg.

Also known as: 0.5%Bupivacaine
combined spinal and epidural anesthesia

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of American Association of anesthetists（ASA）Grade 1、2 or 3
  • Aged between 18 and 85 years
  • Undergoing elective total knee replacement.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Military Region General Hospital, Department of Anesthesiology

Guangzhou, Guangdong, 510010, China

Location

Related Publications (2)

  • 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. doi: 10.1007/BF03011542.

    PMID: 8069988RESULT

  • 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.

    PMID: 21156977RESULT

MeSH Terms

Interventions

Nerve BlockAnesthesia, EpiduralRopivacaineBupivacaine

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, OperativeAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate chief physician

Study Record Dates

First Submitted

March 6, 2014

First Posted

March 12, 2014

Study Start

January 1, 2014

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

September 11, 2014

Record last verified: 2014-09

Locations

CN(1)