Osteo Arthritis KneeNCT03205540
Epidural Analgesia vs Adductor Canal Block in Bilateral TKA
A study testing Continuous epidural block and Bilateral single-shot bilateral adductor canal blocks in people with Osteo Arthritis Knee, run by Mahidol University at 1 site in Thailand.
Trial summary
This study evaluates postoperative analgesic efficacy within 48 hours between epidural analgesia and single-shot bilateral adductor canal blocks in bilateral total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Continuous epidural block and Bilateral single-shot bilateral adductor canal blocks
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteThailand
- Study dates
- 1 Aug 2017to 1 May 2021
- 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 undergoing bilateral total knee arthroplasty
- American Society of Anesthesiologists physical status classification 1-3
Who cannot join
- Participants deny to enroll the study
- Allergy to bupivacaine
- Weight less than 50 kilograms
- Hepatic disease
- Contraincation for neuraxial block or adductor canal block
- Uncontrolled cardiovascular disease
- Creatinine clearance less than 50 ml/min
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
About this study
Official title: Comparison Efficacy of Analgesic Techniques: Continuous Epidural Analgesia Versus Bilateral Single-shot Adductor Canal Blocks in Patients Undergoing Bilateral Total Knee Arthroplasty
This study evaluates postoperative analgesic efficacy within 48 hours between epidural analgesia and single-shot bilateral adductor canal blocks in bilateral total knee arthroplasty. Half of participants will be received continuous epidural analgesia, while other half of participants will be received single-shot bilateral adductor canal blocks.
Read the detailed description
Continuous epidural analgesia is effective postoperative pain control but it has some limitations in patients with hypotension, concurrent anticoagulants, technical difficulty, urinary retention.
Adductor canal block is less invasive than continuous epidural analgesia. It provides effective analgesia for total knee arthroplasty and preserves quadriceps muscle strength.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Continuous epidural block, Bilateral single-shot bilateral adductor canal blocks
- Keywords
- Continuous epidural analgesia, Bilateral single-shot adductor canal blocks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous epidural blockProcedure or surgery
Continuous epidural block at level L2-3 or L3-4 with 0.0625% bupivacaine + fentanyl 2 mcg/ml infusion epidurally 5 ml/hr for 48 hours postoperatively.
Bilateral single-shot bilateral adductor canal blocksProcedure or surgery
Bilateral single-shot adductor canal blocks, ultrasound guidance, with 0.33% bupivacaine 15 ml on each side.
| Study group | Role | What they receive |
|---|---|---|
| Epidural analgesia | Experimental | Lumbar continuous epidural block Receives: Procedure: Continuous epidural block |
| Bilateral ACB | Experimental | Ultrasound-guided bilateral adductor canal blocks Receives: Procedure: Bilateral single-shot bilateral adductor canal blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scores at rests
numerical rating scales
Measured: 48 hours postoperatively
Secondary outcomes (3)
morphine consumptions
total miligrams of morphine use in each arm
Measured: 48 hours postoperatively
pain scores on movement
numerical rating scales
Measured: 48 hours postoperatively
side effects of interventions
nausea vomiting hypotension
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 posted2 Jul 2017
- Study start1 Aug 2017
- Primary completion30 Jan 2021
- Study completion1 May 2021
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 Osteo Arthritis KneeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suwimon Tangwiwat, Mahidol University
- Investigators
- Suwimon Tangwiwat, MD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205540
- Sponsor's protocol ID
- Si 245/2017
- Status last verified
- May 2021
- First submitted
- 29 Jun 2017
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 22146199Choi PT, Bhandari M, Scott J, Douketis J. Epidural analgesia for pain relief following hip or knee replacement. Cochrane Database Syst Rev. 2003;2003(3):CD003071. doi: 10.1002/14651858.CD003071.
PubMed 12917945Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.
PubMed 22221014Gerrard AD, Brooks B, Asaad P, Hajibandeh S, Hajibandeh S. Meta-analysis of epidural analgesia versus peripheral nerve blockade after total knee joint replacement. Eur J Orthop Surg Traumatol. 2017 Jan;27(1):61-72. doi: 10.1007/s00590-016-1846-z. Epub 2016 Sep 3.
PubMed 27592218Fowler SJ, Symons J, Sabato S, Myles PS. Epidural analgesia compared with peripheral nerve blockade after major knee surgery: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2008 Feb;100(2):154-64. doi: 10.1093/bja/aem373.
PubMed 18211990
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Efficacy of Analgesic Techniques: Continuous Epidural Analgesia Versus Bilateral Single-shot Adductor Canal Blocks in Patients Undergoing Bilateral Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03205540
- Acronym / sponsor ID
- Si 245/2017
- Conditions
- Osteo Arthritis Knee
- Keywords
- Continuous epidural analgesia, Bilateral single-shot adductor canal blocks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 2 Jul 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.
This study evaluates postoperative analgesic efficacy within 48 hours between epidural analgesia and single-shot bilateral adductor canal blocks in bilateral total knee arthroplasty. Half of participants will be received continuous epidural analgesia, while other half of participants will be received single-shot bilateral adductor canal blocks.
Detailed description
Continuous epidural analgesia is effective postoperative pain control but it has some limitations in patients with hypotension, concurrent anticoagulants, technical difficulty, urinary retention.
Adductor canal block is less invasive than continuous epidural analgesia. It provides effective analgesia for total knee arthroplasty and preserves quadriceps muscle strength.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural analgesia | Experimental | Procedure: Continuous epidural blockLumbar continuous epidural block |
| Bilateral ACB | Experimental | Procedure: Bilateral single-shot bilateral adductor canal blocksUltrasound-guided bilateral adductor canal blocks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged more than 18 years old undergoing bilateral total knee arthroplasty
- American Society of Anesthesiologists physical status classification 1-3
Key exclusion criteria (7 listed)
- Participants deny to enroll the study
- Allergy to bupivacaine
- Weight less than 50 kilograms
- Hepatic disease
- Contraincation for neuraxial block or adductor canal block
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 |
|---|---|---|
| Continuous epidural blockContinuous epidural block at level L2-3 or L3-4 with 0.0625% bupivacaine + fentanyl 2 mcg/ml infusion epidurally 5 ml/hr for 48 hours postoperatively. | Procedure or surgery | Epidural analgesia |
| Bilateral single-shot bilateral adductor canal blocksBilateral single-shot adductor canal blocks, ultrasound guidance, with 0.33% bupivacaine 15 ml on each side. | Procedure or surgery | Bilateral ACB |
Primary outcome
pain scores at rests
Time frame: 48 hours postoperatively
numerical rating scales
3 secondary outcomes
morphine consumptions
Time frame: 48 hours postoperatively
pain scores on movement
Time frame: 48 hours postoperatively
side effects of interventions
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 26 May 2021.
- 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 12917945Choi PT, Bhandari M, Scott J, Douketis J. Epidural analgesia for pain relief following hip or knee replacement. Cochrane Database Syst Rev. 2003;2003(3):CD003071. doi: 10.1002/14651858.CD003071.
- Background: PubMed 22221014Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.
- Background: PubMed 27592218Gerrard AD, Brooks B, Asaad P, Hajibandeh S, Hajibandeh S. Meta-analysis of epidural analgesia versus peripheral nerve blockade after total knee joint replacement. Eur J Orthop Surg Traumatol. 2017 Jan;27(1):61-72. doi: 10.1007/s00590-016-1846-z. Epub 2016 Sep 3.
- Background: PubMed 18211990Fowler SJ, Symons J, Sabato S, Myles PS. Epidural analgesia compared with peripheral nerve blockade after major knee surgery: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2008 Feb;100(2):154-64. doi: 10.1093/bja/aem373.
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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.
Suwimon Tangwiwat, MD principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous epidural block and Bilateral single-shot bilateral adductor canal blocks in people with Osteo Arthritis Knee, 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 2 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 26 May 2021. 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?
pain scores at rests (time frame: 48 hours postoperatively). 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 NCT03205540, 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 26 May 2021.