NCT01172197

Brief Summary

The anaesthetic management of patients undergoing total knee replacement is still not standardised. Epidural analgesia is common, but is associated with bilateral lower limb motor block and limited mobilisation. Spinal anaesthesia with intrathecal morphine provides good pain relief, but only for 12 to 16 hours, and is often associated with nausea and vomiting. Combined single injection femoral / sciatic blocks give good pain relief, but for a variable length of time (between 12 and 24 hours). In contrast, continuous femoral perineural infusion of local anaesthetic provides very good pain relief for several days. Pain relief is maintained by a constant infusion of local anaesthetic using an elastomeric ball. The investigators overriding aim is to develop a local anaesthetic regimen which offers complete pain relief for at least 48 hours, yet allows full mobilisation within 24 hours Given that ropivacaine may offer a more advantageous pharmacological profile (less lipid solubility) compared to levobupivacaine, the investigators feel it is pertinent to investigate the capacity of ropivacaine to prevent pain relief after surgery. Thus, the investigators aim in this study is to compare the median effective dose of levobupivacaine with the of ropivacaine for preventive pain relief after total knee replacement. Further, calculation of the equipotent median effective dose's of each local anaesthetic allied to objective measurement of quadriceps motor block using an electromyogram will allow us to determine the sensory - motor split of each local anaesthetic.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_4 pain

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_4 pain

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
6.6 years until next milestone

Results Posted

Study results publicly available

May 9, 2018

Completed
Last Updated

May 9, 2018

Status Verified

April 1, 2018

Enrollment Period

2.7 years

First QC Date

July 28, 2010

Results QC Date

April 9, 2018

Last Update Submit

April 9, 2018

Conditions

PainArthroplasty, Replacement, Knee

Keywords

local anestheticlevobupivacaineropivacainefemoral perineural block

Outcome Measures

Primary Outcomes (1)

  • Pain

    Number achieving pain on movement of knee measured as 0 on a verbal pain rating scale at 30h after start of perineural infusion

    30 hours

Study Arms (2)

Ropivacaine

ACTIVE COMPARATOR

Local anaesthetic bolus and infusion

Drug: Levobupivacaine

Levobupivacaine

ACTIVE COMPARATOR

Local anaesthetic bolus and infusion

Drug: Ropivacaine

Interventions

LevobupivacaineDRUG

Femoral bolus 150μM followed by femoral infusion 400μM

Also known as: Chirocaine
Ropivacaine
RopivacaineDRUG

Bolus and infusion

Also known as: Naropin
Levobupivacaine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients \>18 years of age and non pregnant presenting for elective knee replacement

You may not qualify if:

  • Signs of cardiac failure (3rd heart sound, lung crepitations)
  • Type I and type II diabetes
  • Abnormal cardiac arrhythmias
  • Hypovolaemia
  • Presence of seizures,
  • Dementia,
  • Depression
  • Encephalopathy,
  • Terminal illness with a life expectancy \< 3 months
  • Age \< 18 years
  • Pregnant
  • Coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Interventions

LevobupivacaineRopivacaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Dr G McLeod
Organization
NHS Tayside
g.a.mcleod@dundee.ac.uk
+44 1382 7974440848

Study Officials

  • Graeme A McLeod, MD FRCA

    NHS Tayside

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2010

First Posted

July 29, 2010

Study Start

January 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

May 9, 2018

Results First Posted

May 9, 2018

Record last verified: 2018-04