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

Osteoarthritis, Knee Clinical Trial

— BLOCKS-II  

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: Unknown status

Administrative data

• NCT number: NCT01935648
• Other study ID #: 13/ANAES/02
• Status: Unknown status
• Phase: N/A
• First received: July 29, 2013
• Last updated: September 2, 2013
• Start date: September 2013
• Est. completion date: January 2014

Study information

• Verified date: September 2013
• Source: Golden Jubilee National Hospital
• Contact: Michael Gill, MBChB
• Phone: 01419515000
• Email: Mike.Gill[@]gjnh.scot.nhs.uk
• Is FDA regulated: No
• 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 hip 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: Unknown status
• Enrollment: 30
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• 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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, 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 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	Vital signs of heart rate and blood pressure	Vital signs will be recorded (at each time point) when blood samples are taken.	Start of surgery until 24 hours postoperatively
Secondary	Continuous 24 hour electrocardiograph monitoring	Electrocardiograph data will be reported using analysis software to provide a summary of heart rhythm over the study period. Both minor abnormalities (ectopic beats) and major abnormalities (loss of sinus rhythm, heart block) will be detected and reported.	First 24 hours after surgery
Secondary	Symptoms of local anaesthetic toxicity	Patients will be specifically questioned (at each time point) on whether they have any of the following symptoms: Perioral tingling, dizziness, blurred vision, nausea	Start of surgery until 24 hours postoperatively
Secondary	Signs of local anaesthetic toxicity	Patients will be specifically assessed (at each time point) for the following signs: Confusion/agitation, (loss of consciousness, seizure activity, cardiac arrest)	Start of surgery until 24 hours postoperatively