Clinical trial NCT03258697: The Pharmacokinetics and Effectiveness of Local LevoBupivacaine Injection on Primary Total Joint Replacement Model.
Official title: The Pharmacokinetics and Effectiveness of Different Methods of Local LevoBupivacaine Injection, a Prospective Randomized Case Control Clinical Study on Primary Total Joint Replacement Model.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthropathy
Keywords: Local analgesia, Pharmacokinetics, Total joint replacement
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 90
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. PCA only
2. Peri-articular Levobupivacaine + PCA
3. Intra-articular Levobupivacaine + PCA
Primary purpose: TREATMENT

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 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dosage of analgesic opioid agent
timeFrame: post-operative day2
Secondary outcomes:
measure: Blood concentration of LevoBupivacaine
timeFrame: 25min, 90min, and coming morning after LevoBupivacaine injection
Other outcomes:
measure: Functional score
timeFrame: Baseline, Post-operative day1, day2, week2, week6, week12, week24
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
Study officials:
affiliation: Chang Gung Memorial Hospital, Linkou, Taiwan
name: Wei-Chen Lo, M.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.