Status:

COMPLETED

The Pharmacokinetics and Effectiveness of Local LevoBupivacaine Injection on Primary Total Joint Replacement Model.

Lead Sponsor:

Chang Gung Memorial Hospital

Conditions:

Arthropathy

Eligibility:

All Genders

50-80 years

Phase:

NA

Brief Summary

Total joint replacement is an ideal procedure to treat end stage joint disease. Good post-op pain relief could accelerate patient recovery and rehabilitation, and decrease admission days and medical c...

Detailed Description

Single large dose of LevoBupivacaine had been proved good analgesic effect in total joint replacement surgery. However, the safety was not well studied. For better understanding the effect and safety ...

Eligibility Criteria

Inclusion

  • Primary total joint replacement, no previous open surgery on the same joint
  • Age 50\~80 y/o, Pre-operative diagnosis: degenerative osteoarthritis
  • Pre-operative deformity: varus \<15°, valgus \<15°, flexion contracture \<15°.
  • Patients with normal heart function
  • Willing to receive post-operative questionnaire and outpatient clinic follow-up

Exclusion

  • Allergy to Patient-Controlled Analgesia or LevoBupivacaine
  • Mental or cognitive illness that couldn't well response to questionnaire
  • American Society Anesthesiologist more than III degree
  • Liver cirrhosis, chronic renal insufficiency, heart disease or arrhythmia, insulin-dependent diabetes mellitus, and previous narcotic abuse history.
  • Not suitable for using patient-controlled analgesia pump by evaluation of anesthesiologist

Key Trial Info

Start Date :

October 17 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 31 2019

Estimated Enrollment :

90 Patients enrolled

Trial Details

Trial ID

NCT03258697

Start Date

October 17 2017

End Date

May 31 2019

Last Update

June 4 2024

Active Locations (1)

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Chang Gung Memorial Hospital, Linkou

Taoyuan, Taiwan, 333