Bilateral Total Knee ArthroplastyNCT03249662
Efficacy of Pain Control in Different Bupivacaine Dose in Periarticular Injection in Bilateral Total Knee Arthroplasty
A study testing bupivacaine 200 mg and bupivacaine 100 mg in people with Bilateral Total Knee Arthroplasty, run by Mahidol University at 1 site in Thailand.
Trial summary
To study efficacy of postoperative pain control of different concentrations of bupivacaine for periarticular infiltration, part of multimodal analgesia, in bilateral total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bilateral Total Knee Arthroplasty
- What is being tested?
- bupivacaine 200 mg and bupivacaine 100 mg
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 27 Sep 2017to 14 Sep 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged more than 18 years old
- American society of anesthesiologists physical status classification 1-3
- Undergoing bilateral total knee arthroplasty with spinal anesthesia and single shot bilateral adductor canal block
Who cannot join
- Allergy to bupivacaine
- Body weight less than 50 kilograms
- Hepatic disease
- Coagulopathy
- Creatinine clearance less than 60 ml/min
- Uncontrolled cerebrovascular disease
- Hematocrit less than 35%
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital
Bangkok Noi, Bangkok, 10700
About this study
Official title: Efficacy of Pain Management in Different Concentrations of Bupivacaine in Periarticular Injection and Plasma Concentrations of Bupivacaine in Patients Undergoing Bilateral Knee Arthroplasty
To study efficacy of postoperative pain control of different concentrations of bupivacaine for periarticular infiltration, part of multimodal analgesia, in bilateral total knee arthroplasty.
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.
Read the detailed description
Adequate postoperative pain control reduce postoperative morbidity, multimodal analgesia techniques is used for achieve this goal. multimodal analgesia for bilateral total knee arthroplasty are peripheral nerve block, periarticular infiltration, NSAIDs, gabapentins and others. patients undergoing bilateral total knee arthroplasty in siriraj hospital receive spinal anesthesia, single shot bilateral adductor canal block and bilateral periarticular infiltration with bupivacaine so patient receive a large dose of bupivacaine. the investigators study the efficacy of postoperative pain of reduced dose of bupivacaine for periarticular infiltration. and study plasma level of bupivacaine.
- Conditions
- Bilateral Total Knee Arthroplasty
- Being tested
- bupivacaine 200 mg, bupivacaine 100 mg
- Keywords
- periarticular infiltration, postoperative pain management, plasma level of bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaine 200 mgProcedure or surgery
bupivacaine 200 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration
bupivacaine 100 mgDrug
bupivacaine 100 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine 100 mg | Experimental | 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 Receives: Drug: bupivacaine 100 mg |
| bupivacaine 200 mg | Active comparator | bupivacaine 200 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration Receives: Procedure: bupivacaine 200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain score
Numerical rating scale at rest and movement in the first 24 hours postoperatively
Measured: 0-24 hours postoperative
Secondary outcomes (3)
plasma bupivacaine level
plasma bupivacaine level at 40 minutes after 1st articular infiltration, 15,30,45,60,90 minutes after 2nd periarticular infiltration
Measured: 40 minutes after 1st articular infiltration, 15,30,45,60,90 minutes after 2nd periarticular infiltratio
postoperative morphine consumption
postoperative morphine consumption at first 24 hours and 24-48 hours postoperatively
Measured: first 24 hours and 24-48 hours postoperatively
ambulation
patient can walk with assistances within 48 hours postoperatively
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start27 Sep 2017
- Primary completion14 Sep 2020
- Study completion14 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Bilateral Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sukanya dej-arkom, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249662
- Sponsor's protocol ID
- si111/2017
- Status last verified
- Sep 2020
- First submitted
- 10 Aug 2017
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22146199Mullaji 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.
PubMed 20022457Rosenberg 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.
PubMed 15635516Lapmahapaisan 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.
PubMed 25265771Andersen 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.
PubMed 19025523Koh 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.
PubMed 20119672Wulf 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.
PubMed 7978410Lapmahapaisan 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.
PubMed 23539934Dej-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.
PubMed 38243272
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pain Management in Different Concentrations of Bupivacaine in Periarticular Injection and Plasma Concentrations of Bupivacaine in Patients Undergoing Bilateral Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03249662
- Acronym / sponsor ID
- si111/2017
- Conditions
- Bilateral Total Knee Arthroplasty
- Keywords
- periarticular infiltration, postoperative pain management, plasma level of bupivacaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 27 Sep 2017 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 15 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.
To study efficacy of postoperative pain control of different concentrations of bupivacaine for periarticular infiltration, part of multimodal analgesia, in bilateral total knee arthroplasty.
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.
Detailed description
Adequate postoperative pain control reduce postoperative morbidity, multimodal analgesia techniques is used for achieve this goal. multimodal analgesia for bilateral total knee arthroplasty are peripheral nerve block, periarticular infiltration, NSAIDs, gabapentins and others. patients undergoing bilateral total knee arthroplasty in siriraj hospital receive spinal anesthesia, single shot bilateral adductor canal block and bilateral periarticular infiltration with bupivacaine so patient receive a large dose of bupivacaine. the investigators study the efficacy of postoperative pain of reduced dose of bupivacaine for periarticular infiltration. and study plasma level of bupivacaine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bupivacaine 100 mg | Experimental | Drug: bupivacaine 100 mgbupivacaine 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 200 mg | Active comparator | Procedure: bupivacaine 200 mgbupivacaine 200 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged more than 18 years old
- American society of anesthesiologists physical status classification 1-3
- Undergoing bilateral total knee arthroplasty with spinal anesthesia and single shot bilateral adductor canal block
Key exclusion criteria (7 listed)
- Allergy to bupivacaine
- Body weight less than 50 kilograms
- Hepatic disease
- Coagulopathy
- Creatinine clearance less than 60 ml/min
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 |
|---|---|---|
| bupivacaine 200 mgbupivacaine 200 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration | Procedure or surgery | bupivacaine 200 mg |
| bupivacaine 100 mgbupivacaine 100 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration | Drug | bupivacaine 100 mg |
Primary outcome
postoperative pain score
Time frame: 0-24 hours postoperative
Numerical rating scale at rest and movement in the first 24 hours postoperatively
3 secondary outcomes
plasma bupivacaine level
Time frame: 40 minutes after 1st articular infiltration, 15,30,45,60,90 minutes after 2nd periarticular infiltratio
postoperative morphine consumption
Time frame: first 24 hours and 24-48 hours postoperatively
ambulation
Time frame: 48 hours postoperatively
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 16 Sep 2020.
- Background: PubMed 22146199Dimitris 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.
- Background: PubMed 20022457Mullaji 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.
- Background: PubMed 15635516Rosenberg 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.
- Background: PubMed 25265771Lapmahapaisan 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.
- Background: PubMed 19025523Andersen 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.
- Background: PubMed 20119672Koh 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.
- Background: PubMed 7978410Wulf 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.
- Background: PubMed 23539934Lapmahapaisan 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.
- Derived from this study: PubMed 38243272Dej-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.
- Individual participant dataSharing planned: Undecided
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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.
sukanya dej-arkom, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bupivacaine 200 mg and bupivacaine 100 mg in people with Bilateral Total Knee Arthroplasty, run by Mahidol University at 1 site in Thailand.
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 3 inclusion and 7 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 16 Sep 2020. 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 Thailand. 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?
postoperative pain score (time frame: 0-24 hours postoperative). 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 NCT03249662, which also lists 9 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 16 Sep 2020.