Blood Levels of Local Anaesthetic in Knee Arthroplasty Using a Continuous Infusion Device

NCT01935648 | Unknown

• 1 other identifier: 13/ANAES/02
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal is to evaluate ropivacaine blood concentrations during and after local anaesthetic (ropivacaine) infiltration - the Caledonian technique - for total knee replacement surgery. The investigators plan to measure these levels by testing blood samples taken over a timed period. This will allow us to confirm whether the current regimen of local anaesthetic use is within safe limits.

Conditions

Osteoarthritis, Knee

Keywords

Knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• Plasma levels of ropivacaine

  Plasma levels of ropivacaine will be analysed to determine total and free levels. These will be taken following tourniquet release at the following time points: 5, 10, 15, 20, 25, 30 minutes then 1, 4, 12 and 24 hours. Note: Each patient will also have a baseline blood sample taken.

  Start of surgery until 24 hours postoperatively

Secondary Outcomes (4)

• Vital signs of heart rate and blood pressure

  Start of surgery until 24 hours postoperatively

• Continuous 24 hour electrocardiograph monitoring

  First 24 hours after surgery

• Symptoms of local anaesthetic toxicity

  Start of surgery until 24 hours postoperatively

• Signs of local anaesthetic toxicity

  Start of surgery until 24 hours postoperatively

Study Arms (1)

Ropivacaine

Injection of local anaesthetic (ropivacaine) into the knee joint following hip arthroplasty. Total dose 200mls of 0.2% ropivacaine or 400mg at the time of surgery. This will be followed by a continuous infusion of 10mls/hour 0.2% ropivacaine for the subsequent 24 hours.

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

Also known as: Naropin

Ropivacaine

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective knee joint replacement where they will be receiving the Caledonian technique

You may qualify if:

• Male or female patients greater than 65 years of age

You may not qualify if:

• Patients with a known sensitivity/allergy to ropivacaine or amide-type local anaesthetics
• Patients who are not suitable for the Caledonian technique
• Patients who refuse or are unable to give consent
• Patients undergoing bilateral hip replacements
• Patients with known heart, liver or kidney failure

Sponsors & Collaborators

• Golden Jubilee National Hospital: lead
• B. Braun Medical Inc.: collaborator
• University of Strathclyde: collaborator

Study Sites (1)

Golden Jubilee National Hospital

Clydebank, West Dunbartonshire, G81 4DY, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Up to 11 blood samples per patient

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Michael Gill, MBChB

  NHS Research Scotland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Gill, MBChB

CONTACT

01419515000; Mike.Gill@gjnh.scot.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: September 5, 2013
• Study Start: September 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: September 5, 2013

Record last verified: 2013-09

Locations

GB (1)