Efficacy of Pain Control in Different Bupivacaine Dose in Periarticular Injection in Bilateral Total Knee Arthroplasty
NCT ID: NCT03249662
Last Updated: 2020-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
60 participants
INTERVENTIONAL
2017-09-27
2020-09-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
To study plasma concentration of bupivacaine in patient who received spinal anesthesia and single shot bilateral adductor canal block and periarticular infiltration with bupivacaine for safety level.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Local Infiltration With Bupivacaine to Increase Quality of Post-operative Pain Control in Total Knee Replacement
NCT01364194
Liposomal Bupivacaine in Simultaneous Bilateral Total Knee Arthroplasty
NCT02349542
Intrathecal Morphine and Local Infiltration Analgesia in Total Knee Arthroplasty
NCT03434951
Bupivacaine Liposome Suspension Versus a Concentrated Multi Drug Periarticular Injection
NCT02299349
Liposomal Bupivacaine Versus Standard Bupivacaine in the Adductor Canal for Total Knee Arthroplasty
NCT03182933
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
bupivacaine 100 mg
bupivacaine 100 mg ketorolac 30 mg epinephrine 400 mcg add Normal saline solution(NSS) to 80 ml divided to two syringes for bilateral periarticular infiltration
bupivacaine 100 mg
bupivacaine 100 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration
bupivacaine 200 mg
bupivacaine 200 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration
bupivacaine 200 mg
bupivacaine 200 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
bupivacaine 200 mg
bupivacaine 200 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration
bupivacaine 100 mg
bupivacaine 100 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* American society of anesthesiologists physical status classification 1-3
* Undergoing bilateral total knee arthroplasty with spinal anesthesia and single shot bilateral adductor canal block
Exclusion Criteria
* Body weight less than 50 kilograms
* Hepatic disease
* Coagulopathy
* Creatinine clearance less than 60 ml/min
* Uncontrolled cerebrovascular disease
* Hematocrit less than 35%
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mahidol University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
sukanya dej-arkom, MD
Role: PRINCIPAL_INVESTIGATOR
Mahidol University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Faculty of Medicine Siriraj Hospital
Bangkok Noi, Bangkok, Thailand
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Dimitris CN, Taylor BC, Mowbray JG, Steensen RN, Gaines ST. Perioperative morbidity and mortality of 2-team simultaneous bilateral total knee arthroplasty. Orthopedics. 2011 Dec 6;34(12):e841-6. doi: 10.3928/01477447-20111021-02.
Mullaji A, Kanna R, Shetty GM, Chavda V, Singh DP. Efficacy of periarticular injection of bupivacaine, fentanyl, and methylprednisolone in total knee arthroplasty:a prospective, randomized trial. J Arthroplasty. 2010 Sep;25(6):851-7. doi: 10.1016/j.arth.2009.09.007. Epub 2009 Dec 21.
Rosenberg PH, Veering BT, Urmey WF. Maximum recommended doses of local anesthetics: a multifactorial concept. Reg Anesth Pain Med. 2004 Nov-Dec;29(6):564-75; discussion 524. doi: 10.1016/j.rapm.2004.08.003.
Lapmahapaisan S, Chinachoti T, Maisat W, Kleebchan N, Chatsiricharoenkul S, Charoencholvanich K, Rungwattanakij P, Sakulpacharoen N, Sri-In J. Plasma concentrations of bupivacaine after spinal anesthesia with single shot femoral nerve block and periarticular injection in total knee arthroplasty. J Med Assoc Thai. 2014 Jul;97(7):724-9.
Andersen LO, Husted H, Otte KS, Kristensen BB, Kehlet H. High-volume infiltration analgesia in total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Acta Anaesthesiol Scand. 2008 Nov;52(10):1331-5. doi: 10.1111/j.1399-6576.2008.01777.x.
Koh IJ, Kang YG, Chang CB, Kwon SK, Seo ES, Seong SC, Kim TK. Additional pain relieving effect of intraoperative periarticular injections after simultaneous bilateral TKA: a randomized, controlled study. Knee Surg Sports Traumatol Arthrosc. 2010 Jul;18(7):916-22. doi: 10.1007/s00167-010-1051-2. Epub 2010 Jan 30.
Wulf H, Gleim M, Schele HA. Plasma concentrations of bupivacaine after lumbar sympathetic block. Anesth Analg. 1994 Nov;79(5):918-20. doi: 10.1213/00000539-199411000-00017.
Lapmahapaisan S, Chinachoti T, Kongpatanakul S, Chatsiricharoenkul S, Tovnich B, Duangkaew W, Pongnarin P, Sakulpacharoen N, Somcharoen W. Plasma concentrations of bupivacaine after spinal anesthesia with single shot femoral nerve block in total knee arthroplasty. J Med Assoc Thai. 2013 Mar;96(3):312-7.
Dej-Arkom S, Pangthipampai P, Chandranipapongse W, Chatsirichareonkul S, Narkbunnam R, Charoencholvanich K, Tangchittam S, Iamaroon A. Efficacy and safety of different bupivacaine concentrations in periarticular infiltration combined with adductor canal block for bilateral total knee arthroplasty: a randomized controlled trial. Knee Surg Relat Res. 2024 Jan 19;36(1):5. doi: 10.1186/s43019-024-00211-y.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
si111/2017
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.