Clinical Trials Directory

Trials / Completed

CompletedNCT01869946

Blood Levels of Local Anaesthetic in Hip Arthroplasty

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

Status
Completed
Phase
Study type
Observational
Enrollment
20 (actual)
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 hip 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

Interventions

TypeNameDescription
DRUGRopivacaine

Timeline

Start date
2012-08-01
Primary completion
2013-05-01
Completion
2013-05-01
First posted
2013-06-05
Last updated
2013-06-05

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT01869946. Inclusion in this directory is not an endorsement.