ArthropathyNCT03258697
The Pharmacokinetics and Effectiveness of Local LevoBupivacaine Injection on Primary Total Joint Replacement Model.
A study testing Levobupivacaine Hydrochloride in people with Arthropathy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Arthropathy
- What is being tested?
- Levobupivacaine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Oct 2017to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Arthropathy
- Being tested
- Levobupivacaine Hydrochloride
- Keywords
- Local analgesia, Pharmacokinetics, Total joint replacement
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levobupivacaine HydrochlorideDrug
Also called Chirocaine
Different way of LevoBupivacaine injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Levobupivacaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosage of analgesic opioid agent
The total dosage of opioid agent after local LevoBupivacaine injection
Measured: post-operative day2
Secondary outcomes (1)
Blood concentration of LevoBupivacaine
Venous return of local LevoBupivacaine could cause the difference of blood concentration
Measured: 25min, 90min, and coming morning after LevoBupivacaine injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start17 Oct 2017
- Primary completion31 Jan 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ArthropathyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. PCA only 2. Peri-articular Levobupivacaine + PCA 3. Intra-articular Levobupivacaine + PCA
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-Chen Lo, M.S., Principal investigator, Chang Gung Memorial Hospital, Linkou, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258697
- Sponsor's protocol ID
- 201602050A3
- Status last verified
- Aug 2017
- First submitted
- 16 Aug 2017
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25158837Chen 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.
PubMed 24439998Parvataneni 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.
PubMed 17823012Wasudev 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.
PubMed 2310449Meinig 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.
PubMed 3381989
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03258697
- Acronym / sponsor ID
- 201602050A3
- Conditions
- Arthropathy
- Keywords
- Local analgesia, Pharmacokinetics, Total joint replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 23 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- 1. PCA only 2. Peri-articular Levobupivacaine + PCA 3. Intra-articular Levobupivacaine + PCA
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Levobupivacaine HydrochloridePatient had periarticular local analgesic agent, LevoBupivacaine Hydrochloride, during total joint replacement. Patient had baseline Patient-Controlled Analgesia pump. |
| Intra-articular LevoBupivacaine | Experimental | Drug: Levobupivacaine HydrochloridePatient had intra-articular local analgesic agent, LevoBupivacaine Hydrochloride, during total joint replacement. Patient had baseline Patient-Controlled Analgesia pump. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levobupivacaine HydrochlorideAlso: ChirocaineDifferent way of LevoBupivacaine injection | Drug | Intra-articular LevoBupivacaine, Peri-articular LevoBupivacaine |
Primary outcome
Dosage of analgesic opioid agent
Time frame: post-operative day2
The total dosage of opioid agent after local LevoBupivacaine injection
1 secondary outcome
Blood concentration of LevoBupivacaine
Time frame: 25min, 90min, and coming morning after LevoBupivacaine injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Background: PubMed 25158837Chen 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.
- Background: PubMed 24439998Chen 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.
- Background: PubMed 17823012Parvataneni 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.
- Background: PubMed 2310449Wasudev 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.
- Background: PubMed 3381989Meinig 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei-Chen Lo, M.S. principal investigator
Chang Gung Memorial Hospital, Linkou, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levobupivacaine Hydrochloride in people with Arthropathy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosage of analgesic opioid agent (time frame: post-operative day2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03258697, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.