Total Knee ArthroplastyPhase 4NCT03486548
Analgesic Efficacy of Adding SCB With Low Concentration Bupivacaine Combined With Dexamethasone on Pain After TKA
A Phase 4 study testing bupivacaine and dexamethasone, bupivacaine and lidocaine and Ultrasound in people with Total Knee Arthroplasty and Adductor Canal Block, run by Mahidol University at 1 site in Thailand.
Trial summary
This study evaluate the efficacy of adding popliteal sciatic nerve block with low concentration bupivacaine and dexamethasone to abductor canal block for total knee arthroplasty in patient with NSAIDs prescribing precaution. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Total Knee Arthroplasty, Adductor Canal Block, Sciatic Nerve Block
- What is being tested?
- bupivacaine and dexamethasone, bupivacaine and lidocaine and Ultrasound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2018to Feb 2019
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient scheduled for single total knee arthroplasty
- patient with NSAIDs prescribing precautions such as history of NSAIDs allergy, Chronic kidney disease (GFR< 50 ml/min), history of ischemic heart disease or cerebrovascular disease
Who cannot join
- patient refusal
- body weight less than 45 kg
- history of allergy to bupivacaine or dexamethasone
- uncontrolled diabetes mellitus
- contraindicated for spinal block, adductor canal block or sciatic nerve block
- inability to assess pain score (cognitive or psychiatric history)
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- patient scheduled for revision TKA
- preexisting neuropathy or neurological deficit in lower extremity
- preexisting chronic pain (prolonged use of oral morphine 20 mg/day or equivalent)
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, 10700
Busara Sirirvanadandha, MD, +66851429656, busarasiri@yahoo.com
About this study
Official title: Analgesic Efficacy of Adding SCB With Low Concentration Bupivacaine Combined With Dexamethasone to ACB and Periarticular Injection on Postoperative Pain After TKA: Randomized Controlled Study
This study evaluate the efficacy of adding popliteal sciatic nerve block with low concentration bupivacaine and dexamethasone to abductor canal block for total knee arthroplasty in patient with NSAIDs prescribing precaution. Half of participants will receive popliteal sciatic nerve block, abductor canal block and periarticular injection, while the other half will receive a sham block, abductor canal block and periarticular injection.
Read the detailed description
After informed and consent, all patients will be devided into two groups, Sciatic group (group S) and Controlled group (group C). All patients will receive adductor canal block, then patients in group S will receive Sciatic nerve block with low concentration bupivacaine and dexamethasone while partients in group C will receive sham block. All patient will receive spinal anesthesia and intraoperative periarticular injection.
Postoperative pain score, muscle strength, total morphine consumption and adverse events will be record in case record form.
- Being tested
- bupivacaine and dexamethasone, bupivacaine and lidocaine, Ultrasound
- Keywords
- popliteal sciatic nerve block, total knee artgroplasty, adductor canal block, dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaine and dexamethasoneDrug
Also called bupivacaine
adductor canal block with 0.33% bupivacaine 15 ml with ultrasound guided popliteal sciatic block with 0.125% bupivacaine 20 ml and dexamethasone 5 mg
bupivacaine and lidocaineDrug
adductor canal block with 0.33% bupivacaine 15 ml with ultrasound at popliteal sciatic area and subcutaneous infiltration popliteal area with 2% lidocaine 1 ml
UltrasoundDevice
ultrasound
| Study group | Role | What they receive |
|---|---|---|
| control group | Sham comparator | adductor canal block with sham block Receives: Drug: bupivacaine and lidocaine; Device: Ultrasound |
| sciatic group | Experimental | adductor canal block with popliteal sciatic nerve block Receives: Drug: bupivacaine and dexamethasone; Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain score at rest
postoperative pain score at rest at 24 hour
Measured: postoperative 24 hours
Secondary outcomes (7)
postoperative pain score at anterior and posterior site of knee
postoperative pain score at anterior and posterior site of knee at 24 hour
Measured: postoperative 24 hours
postoperative pain score on 45 degree knee flexion and physical therapy
postoperative pain score on 45 degree knee flexion and physical therapy
Measured: postoperative 24 hours
level of tibialis anterior muscle weakness
level of tibialis anterior muscle weakness in 24 hour
Measured: postoperative 24 hours
adverse events
perioperative adverse events such as LAST, hypotension, nausea and vomitting
Measured: postoperative 24 hours
total morphine consumption in postoperative 24 hours
total morphine consumption in postoperative 24 hours
Measured: postoperative 24 hours
patient satisfaction
patient satisfaction score
Measured: postoperative 24 hours
length of hospital stay
length of hospital stay
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study startApr 2018 (estimated)
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Busara Sirivanasandha, MD, Principal investigator, Department of Anesthesia, Siriraj hospital, Mahidol university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486548
- Sponsor's protocol ID
- 768/2560(EC1)
- Status last verified
- Mar 2018
- First submitted
- 15 Mar 2018
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sirivanasandha B, Sutthivaiyakit K, Kerdchan T, Poolsuppasit S, Tangwiwat S, Halilamien P. Adding a low-concentration sciatic nerve block to total knee arthroplasty in patients susceptible to the adverse effects of non-steroidal anti-inflammatory drugs (NSAIDs): a randomized controlled trial. BMC Anesthesiol. 2021 Nov 13;21(1):282. doi: 10.1186/s12871-021-01491-7.
PubMed 34773995
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Adding SCB With Low Concentration Bupivacaine Combined With Dexamethasone to ACB and Periarticular Injection on Postoperative Pain After TKA: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03486548
- Acronym / sponsor ID
- 768/2560(EC1)
- Keywords
- popliteal sciatic nerve block, total knee artgroplasty, adductor canal block, dexamethasone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Apr 2018 (estimated)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 3 Apr 2018 (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 evaluate the efficacy of adding popliteal sciatic nerve block with low concentration bupivacaine and dexamethasone to abductor canal block for total knee arthroplasty in patient with NSAIDs prescribing precaution. Half of participants will receive popliteal sciatic nerve block, abductor canal block and periarticular injection, while the other half will receive a sham block, abductor canal block and periarticular injection.
Detailed description
After informed and consent, all patients will be devided into two groups, Sciatic group (group S) and Controlled group (group C). All patients will receive adductor canal block, then patients in group S will receive Sciatic nerve block with low concentration bupivacaine and dexamethasone while partients in group C will receive sham block. All patient will receive spinal anesthesia and intraoperative periarticular injection.
Postoperative pain score, muscle strength, total morphine consumption and adverse events will be record in case record form.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Sham comparator | Drug: bupivacaine and lidocaine, Device: Ultrasoundadductor canal block with sham block |
| sciatic group | Experimental | Drug: bupivacaine and dexamethasone, Device: Ultrasoundadductor canal block with popliteal sciatic nerve block |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient scheduled for single total knee arthroplasty
- patient with NSAIDs prescribing precautions such as history of NSAIDs allergy, Chronic kidney disease (GFR< 50 ml/min), history of ischemic heart disease or cerebrovascular disease
Key exclusion criteria (9 listed)
- patient refusal
- body weight less than 45 kg
- history of allergy to bupivacaine or dexamethasone
- uncontrolled diabetes mellitus
- contraindicated for spinal block, adductor canal block or sciatic nerve 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 |
|---|---|---|
| bupivacaine and dexamethasoneAlso: bupivacaineadductor canal block with 0.33% bupivacaine 15 ml with ultrasound guided popliteal sciatic block with 0.125% bupivacaine 20 ml and dexamethasone 5 mg | Drug | sciatic group |
| bupivacaine and lidocaineadductor canal block with 0.33% bupivacaine 15 ml with ultrasound at popliteal sciatic area and subcutaneous infiltration popliteal area with 2% lidocaine 1 ml | Drug | control group |
| Ultrasoundultrasound | Device | control group, sciatic group |
Primary outcome
postoperative pain score at rest
Time frame: postoperative 24 hours
postoperative pain score at rest at 24 hour
7 secondary outcomes
postoperative pain score at anterior and posterior site of knee
Time frame: postoperative 24 hours
postoperative pain score on 45 degree knee flexion and physical therapy
Time frame: postoperative 24 hours
level of tibialis anterior muscle weakness
Time frame: postoperative 24 hours
adverse events
Time frame: postoperative 24 hours
total morphine consumption in postoperative 24 hours
Time frame: postoperative 24 hours
patient satisfaction
Time frame: postoperative 24 hours
length of hospital stay
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
- Derived from this study: PubMed 34773995Sirivanasandha B, Sutthivaiyakit K, Kerdchan T, Poolsuppasit S, Tangwiwat S, Halilamien P. Adding a low-concentration sciatic nerve block to total knee arthroplasty in patients susceptible to the adverse effects of non-steroidal anti-inflammatory drugs (NSAIDs): a randomized controlled trial. BMC Anesthesiol. 2021 Nov 13;21(1):282. doi: 10.1186/s12871-021-01491-7.
- Individual participant dataSharing planned: No
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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.
Busara Sirivanasandha, MD principal investigator
Department of Anesthesia, Siriraj hospital, Mahidol university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bupivacaine and dexamethasone, bupivacaine and lidocaine and Ultrasound in people with Total Knee Arthroplasty and Adductor Canal Block, 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 9 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: status not confirmed, as of the sponsor's last update on 3 Apr 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Busara Sirivanasandha, MD (+6624197995, busarasiri@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain score at rest (time frame: postoperative 24 hours). 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 NCT03486548, which also lists 1 linked publication.
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 3 Apr 2018.