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

Arthropathy Clinical Trial

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03258697
• Other study ID #: 201602050A3
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 16, 2017
• Last updated: January 29, 2018
• Start date: October 17, 2017
• Est. completion date: February 28, 2020

Study information

• Verified date: August 2017
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 180
• Est. completion date: February 28, 2020
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthropathy
• Joint Diseases

Intervention

Drug:
• Levobupivacaine Hydrochloride
Different way of LevoBupivacaine injection

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital, Linkou	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

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. — View 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. — View 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. — View 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. Epub 2007 Jul 26. — View Citation

Wasudev G, Smith BE, Limbird TJ. Blood levels of bupivacaine after arthroscopy of the knee joint. Arthroscopy. 1990;6(1):40-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functional score	The difference of functional score	Baseline, Post-operative day1, day2, week2, week6, week12, week24
Primary	Dosage of analgesic opioid agent	The total dosage of opioid agent after local LevoBupivacaine injection	post-operative day2
Secondary	Blood concentration of LevoBupivacaine	Venous return of local LevoBupivacaine could cause the difference of blood concentration	25min, 90min, and coming morning after LevoBupivacaine injection