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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01636869
Other study ID # 010/2555
Secondary ID
Status Completed
Phase Phase 4
First received July 5, 2012
Last updated July 25, 2014
Start date July 2012
Est. completion date July 2014

Study information

Verified date July 2014
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

Patients with knee arthroplasty usually performed under spinal anesthesia with a single-shot femoral nerve block and periarticular block, so we would like to know the plasma concentration of bupivacaine in these patients.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 70 Years
Eligibility Inclusion Criteria:

- age of 30-70 yr

- ASA I-II

- patient undergo total knee arthroplasty under spinal block and single shot femoral nerve block and periarticular block

Exclusion Criteria:

- patient's refusal

- allergic to bupivacaine

- body weight less than 50 kg

- liver disease

- heart disease

- coagulopathy

- Hct<35%

- infection at both groin

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

Drug:
Bupivacaine
20 ml of 0.5% bupivacaine for single-shot femoral nerve block will be done at the beginning then another 20 ml of 0.5% bupivacaine for periarticular block will be performed at the end of operation. Blood sample will be drawn at 60 min after femoral nerve block and before periarticular block, 15, 30, 45, 60 min after periarticular block.

Locations

Country Name City State
Thailand Faculty of Medicine, Siriraj Hospital, Mahidol University Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary plasma concentration of bupivacaine after spinal anesthesia with single-shot femoral nerve block and periarticular block 2 hours Yes
Secondary bupivacaine toxicity 24 hr Yes
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