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

The Pharmacokinetics and Effectiveness of Different Methods of Local LevoBupivacaine Injection, a Prospective Randomized Case Control Clinical Study on Primary Total Joint Replacement Model.

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 cost. Local injection of LevoBupivacaine is an effective method in post-operative pain control. The effectiveness of local analgesia was noticed clinically. However, thorough studies about the pharmacokinetics of LevoBupivacaine, maintenance of effect, influence of post-operative rehabilitation are not well studied in different way of injection. The purpose of this study is to evaluate and analyze the pharmacokinetics and effect of local Levobupivacaine injection in different ways, the amount of post-operative fentanyl requirement after local injection, time to first fentanyl request, pain score, immediate post-operative function, side effect of analgesic agents, and medical cost, and to improve the quality of total joint replacement post-operative care.

Study Overview

• Status: Completed
• Conditions: Arthropathy
• Intervention / Treatment: Drug: Levobupivacaine Hydrochloride

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 of local analgesic agent, we choose LevoBupivacaine with different injection way to find out. We divide patient to three groups, for comparing the effectiveness of LevoBupivacaine, and safety of LevoBupivacaine by checking intra-blood concentration. The pre-emptive analgesics and post-operative analgesics were the same as routine protocol in other total joint replacement.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan City, Taiwan, 333
    • Chang Gung Memorial Hospital, Linkou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Patient-Controlled Analgesia; Patient had no local analgesic agent during total joint replacement. Patient had baseline Patient-Controlled Analgesia pump.
Active Comparator: Peri-articular LevoBupivacaine; Patient had periarticular local analgesic agent, LevoBupivacaine Hydrochloride, during total joint replacement. Patient had baseline Patient-Controlled Analgesia pump.	Drug: Levobupivacaine Hydrochloride; Different way of LevoBupivacaine injection; Other Names: Chirocaine
Experimental: Intra-articular LevoBupivacaine; Patient had intra-articular local analgesic agent, LevoBupivacaine Hydrochloride, during total joint replacement. Patient had baseline Patient-Controlled Analgesia pump.	Drug: Levobupivacaine Hydrochloride; Different way of LevoBupivacaine injection; Other Names: Chirocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosage of analgesic opioid agent	The total dosage of opioid agent after local LevoBupivacaine injection	post-operative day2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood concentration of LevoBupivacaine	Venous return of local LevoBupivacaine could cause the difference of blood concentration	25min, 90min, and coming morning after LevoBupivacaine injection

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional score	The difference of functional score	Baseline, Post-operative day1, day2, week2, week6, week12, week24

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Wei-Chen Lo, M.S., Chang Gung Memorial Hospital, Linkou, Taiwan

Publications and helpful links

General Publications

• Parvataneni HK, Shah VP, Howard H, Cole N, Ranawat AS, Ranawat CS. Controlling pain after total hip and knee arthroplasty using a multimodal protocol with local periarticular injections: a prospective randomized study. J Arthroplasty. 2007 Sep;22(6 Suppl 2):33-8. doi: 10.1016/j.arth.2007.03.034. Epub 2007 Jul 26.
• Chen CC, Yang CC, Hu CC, Shih HN, Chang YH, Hsieh PH. Acupuncture for pain relief after total knee arthroplasty: a randomized controlled trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):31-6. doi: 10.1097/AAP.0000000000000138.
• Chen DW, Hu CC, Chang YH, Lee MS, Chang CJ, Hsieh PH. Intra-articular bupivacaine reduces postoperative pain and meperidine use after total hip arthroplasty: a randomized, double-blind study. J Arthroplasty. 2014 Dec;29(12):2457-61. doi: 10.1016/j.arth.2013.12.021. Epub 2013 Dec 19.
• Wasudev G, Smith BE, Limbird TJ. Blood levels of bupivacaine after arthroscopy of the knee joint. Arthroscopy. 1990;6(1):40-2. doi: 10.1016/0749-8063(90)90095-u.
• Meinig RP, Holtgrewe JL, Wiedel JD, Christie DB, Kestin KJ. Plasma bupivacaine levels following single dose intraarticular instillation for arthroscopy. Am J Sports Med. 1988 May-Jun;16(3):295-300. doi: 10.1177/036354658801600317.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2017
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: August 16, 2017
• First Submitted That Met QC Criteria: August 22, 2017
• First Posted (Actual): August 23, 2017

Study Record Updates

• Last Update Posted (Actual): June 4, 2024
• Last Update Submitted That Met QC Criteria: June 2, 2024
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Local analgesia, Pharmacokinetics, Total joint replacement
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Levobupivacaine
• Other Study ID Numbers: 201602050A3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No