NCT01935648

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Golden Jubilee National Hospital · Other Government
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	Ropivacaine

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2013-09-05
• Last updated: 2013-09-05

Locations

1 site across 1 country: United Kingdom