The primary objective of this pilot study is to describe *QRS widening, *QTc interval and other ECG findings (bradycardia, tachycardia, ST-segment elevation) pre-, peri- and postoperatively in a cohort of 20 patients, receiving in total 300 mg…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is QRS widening (delta QRS) and delta QTc-intervals
measured with a 24 hour Holter ECG compared to baseline ECG.
Secondary outcome
Secondary study outcomes are bradycardia and/or tachycardia, and/or
ST-elevation compared to basaeline ECG.
Background summary
Ropivacaine as LIA is succesfully used for several years during THA in clinical
practice. However, adverse effects of ropivacaine and in particular cardiac
adverse effects for this route of administration are not clarified yet. The
purpose of this study is to identify the occurence of cardiac adverse effects
of ropivacaine administered by LIA during THA.
Study objective
The primary objective of this pilot study is to describe *QRS widening, *QTc
interval and other ECG findings (bradycardia, tachycardia, ST-segment
elevation) pre-, peri- and postoperatively in a cohort of 20 patients,
receiving in total 300 mg ropivacaine as a local anaesthetic with LIA
technique. All ECG data will be compared to baseline ECG, either as 12-lead ECG
pre-operatively or as Holter ECG-data pre-operatively.
The secondary objective of this pilot study is to see if measurement of pre-
and postoperatively 12-lead ECG together with 24 hour Holter ECG measurement
starting before surgery is routinely feasible.
Study design
This prospective cohort pilot study examines the occurence of cardiac adverse
effects of wound infiltrated ropivacaine in patients durin THA. The aim of this
study is to include 20 evaluable patients. The occurence of cardiac adverse
effects compared to the pre-operative ECG will be examined.
Study burden and risks
The pre- and post-operative ECG, and the 24 hour Holter ECG are the only burden
for the patient. However this has no influence on the medical condition of the
patient nor the mobilization of the patient.
This study has neither risks nor benfits for the patient. We anticipate that
the results of this study will give more insight in cardiac adverse effects of
ropivacaine after LIA and this might benefit future patients.
Reinier de Graafweg 7
Delft 2625 AD
NL
Reinier de Graafweg 7
Delft 2625 AD
NL
Listed location countries
Age
Inclusion criteria
Patients 18 years and older and scheduled for THA in Reinier de Graaf hospital.
Exclusion criteria
Allergy for ropivacaine.
Moderate or severe cardiac disease, bronchial asthma (severe valave insuffiency, angina pectoris 2/4 or more, congestive heart failure, rhythmic disorder).
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL43674.098.13 |