Plasma Concentrations of Bupivacaine After Peri-articular Injection in Total Knee Arthroplasty

Total Knee Arthroplasty Clinical Trial

Official title:

Plasma Concentrations of Bupivacaine After Spinal Anesthesia With Single Shot Femoral Nerve Block and Peri-articular Injection in Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01636869
• Other study ID #: 010/2555
• 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

Related Conditions & MeSH terms

• Periarticular Block
• Serum Bupivacaine Level
• Total Knee Arthroplasty

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