Blood Levels of Local Anaesthetic in Knee Arthroplasty

Arthritis of Knee Clinical Trial

— BLOCKS  

Official title:

Blood Levels of Local Anaesthetic in Knee Arthroplasty: A Pharmacological Study of Ropivacaine Blood Levels During the Caledonian Technique for Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873313
• Other study ID #: 12/ANAES/01
• Status: Completed
• Phase: N/A
• First received: June 6, 2013
• Last updated: June 10, 2013
• Start date: August 2012
• Est. completion date: January 2013

Study information

• Verified date: June 2013
• Source: Golden Jubilee National Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Description:

Local anaesthetic (LA) toxicity may occur when the blood levels of a drug become particularly high. There is a need to confirm that the technique is safe to use. In addition, journal case reports may only describe serious side-effects of toxicity such as abnormal heart rhythms whilst more subtle clinical signs are rarely reported.

The investigators would like to study whether or not toxic levels may be approached in some patients or whether more subtle toxicity symptoms and signs are missed. For example, irregular heartbeat, low blood pressure or confusion/agitation.

Therefore, the investigators intend to study ropivacaine blood levels in patients receiving a total knee replacement in the Golden Jubilee National Hospital. A series of timed samples will be taken during the perioperative period. The anaesthesia and surgery will be performed as routine and no new treatment will be involved. Patient demographics, ropivacaine blood levels and clinical observations following LA administration will be collected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Male or female patients greater than 65 years of age

Exclusion Criteria:

• 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis of Knee

Intervention

Drug:
• Ropivacaine

Locations

Country	Name	City	State
United Kingdom	Golden Jubilee National Hospital	Clydebank	West Dunbartonshire

Sponsors (3)

Lead Sponsor	Collaborator
Golden Jubilee National Hospital	B. Braun Medical Inc., University of Strathclyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma levels of ropivacaine	Plasma levels of ropivacaine were analysed to determine total and free levels	First 24 hours after surgery	Yes
Secondary	Clinical observations	Clinical observations, including potential symptoms and signs of local anaesthetic toxicity, were recorded at the same time as blood sampling	First 24 hours after surgery	Yes
Secondary	Evidence of dysrrhythmias as measured by 24-hour Holter monitoring	24-hour Holter monitoring was conducted to detect any potential sequelae of local anaesthetic toxicity	First 24 hours after surgery	Yes