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

NCT03258697 | Completed

• 1 other identifier: 201602050A3
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthropathy

Keywords

Local analgesia, Pharmacokinetics, Total joint replacement

Outcome Measures

Primary Outcomes (1)

• Dosage of analgesic opioid agent

  The total dosage of opioid agent after local LevoBupivacaine injection

  post-operative day2

Secondary Outcomes (1)

• Blood concentration of LevoBupivacaine

  25min, 90min, and coming morning after LevoBupivacaine injection

Other Outcomes (1)

• Functional score

  Baseline, Post-operative day1, day2, week2, week6, week12, week24

Study Arms (3)

Patient-Controlled Analgesia

NO INTERVENTION

Patient had no local analgesic agent during total joint replacement. Patient had baseline Patient-Controlled Analgesia pump.

Peri-articular LevoBupivacaine

ACTIVE COMPARATOR

Patient had periarticular local analgesic agent, LevoBupivacaine Hydrochloride, during total joint replacement. Patient had baseline Patient-Controlled Analgesia pump.

Drug: Levobupivacaine Hydrochloride

Intra-articular LevoBupivacaine

EXPERIMENTAL

Patient had intra-articular local analgesic agent, LevoBupivacaine Hydrochloride, during total joint replacement. Patient had baseline Patient-Controlled Analgesia pump.

Drug: Levobupivacaine Hydrochloride

Interventions

Levobupivacaine Hydrochloride DRUG

Different way of LevoBupivacaine injection

Also known as: Chirocaine

Intra-articular LevoBupivacaine; Peri-articular LevoBupivacaine

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital, Linkou

Taoyuan, 333, Taiwan

Location

Related 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.

  PMID: 25158837 BACKGROUND

• 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.

  PMID: 24439998 BACKGROUND

• 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.

  PMID: 17823012 BACKGROUND

• 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.

  PMID: 2310449 BACKGROUND

• 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.

  PMID: 3381989 BACKGROUND

MeSH Terms

Conditions

Joint Diseases

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Wei-Chen Lo, M.S.

  Chang Gung Memorial Hospital, Linkou, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Patient blinded, observer blinded study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. PCA only 2. Peri-articular Levobupivacaine + PCA 3. Intra-articular Levobupivacaine + PCA

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 23, 2017
• Study Start: October 17, 2017
• Primary Completion: January 31, 2019
• Study Completion: May 31, 2019
• Last Updated: June 4, 2024

Record last verified: 2017-08

Locations

TW (1)