ClinicalTrials.gg
Status unknownNCT03486548Updated Apr 3, 2018

Analgesic Efficacy of Adding SCB With Low Concentration Bupivacaine Combined With Dexamethasone on Pain After TKA

A Phase 4 interventional study of bupivacaine and dexamethasone and bupivacaine and lidocaine in Total Knee Arthroplasty, Adductor Canal Block and Sciatic Nerve Block, sponsored by Mahidol University. Status unknown at 1 site in Thailand. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-04-03.

Sponsored by Mahidol University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Total Knee Arthroplasty
  • Adductor Canal Block
  • Sciatic Nerve Block

Keywords

  • popliteal sciatic nerve block
  • total knee artgroplasty
  • adductor canal block
  • dexamethasone
03

In context

Lead sponsor

Mahidol University is the lead sponsor of 747 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patient scheduled for single total knee arthroplasty
  • patient with NSAIDs prescribing precautions such as history of NSAIDs allergy, Chronic kidney disease (\< 50 ml/min), history of ischemic heart disease or cerebrovascular disease

Exclusion criteria

Exclusion Criteria:

  • patient refusal
  • body weight less than 45 kg
  • history of allergy to bupivacaine or dexamethasone
  • uncontrolled diabetes mellitus
  • for spinal block, adductor canal block or sciatic nerve block
  • inability to assess pain score (cognitive or psychiatric history)
  • 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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Sham comparator
    control group

    adductor canal block with sham block

    Drug: bupivacaine and lidocaine · Device: Ultrasound

  • Experimental
    sciatic group

    adductor canal block with popliteal sciatic nerve block

    Drug: bupivacaine and dexamethasone · Device: Ultrasound

Interventions

  • Drugbupivacaine and dexamethasone

    Drug pages: Bupivacaine · Dexamethasone

    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

    Also known as: bupivacaine

  • Drugbupivacaine and lidocaine

    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

  • DeviceUltrasound

    ultrasound

06

What researchers measure

Primary outcomes

  1. postoperative pain score at rest

    postoperative pain score at rest at 24 hour

    Time frame: postoperative 24 hours

Secondary outcomes

  1. postoperative pain score at anterior and posterior site of knee

    postoperative pain score at anterior and posterior site of knee at 24 hour

    Time frame: postoperative 24 hours

  2. postoperative pain score on 45 degree knee flexion and physical therapy

    postoperative pain score on 45 degree knee flexion and physical therapy

    Time frame: postoperative 24 hours

  3. level of tibialis anterior muscle weakness

    level of tibialis anterior muscle weakness in 24 hour

    Time frame: postoperative 24 hours

  4. adverse events

    perioperative adverse events such as LAST, hypotension, nausea and vomitting

    Time frame: postoperative 24 hours

  5. total morphine consumption in postoperative 24 hours

    total morphine consumption in postoperative 24 hours

    Time frame: postoperative 24 hours

  6. patient satisfaction

    patient satisfaction score

    Time frame: postoperative 24 hours

  7. length of hospital stay

    length of hospital stay

    Time frame: 7 days

07

Study locations

1 site
  • Siriraj Hospital, Mahidol University
    Bangkoknoi, Bangkok 10700, Thailand
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Apr 2018; primary completion for Feb 2019, 10 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 15, 2018
First posted
Apr 3, 2018
StartEst.
Apr 2018
Primary completionEst.
Feb 2019
CompletionEst.
Feb 2019
Last update
Apr 3, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03486548
Lead sponsor
Mahidol University
Responsible party
Sponsor
First posted
Apr 3, 2018
Start date
Apr 2018 (estimated)
Primary completion
Feb 2019 (estimated)
Completion
Feb 2019 (estimated)
Last update
Apr 3, 2018

Study contacts

Busara Sirivanasandha, MD
Contact
busarasiri@yahoo.com
+6624197995
Busara Sirivanasandha, MD
principal investigator · Department of Anesthesia, Siriraj hospital, Mahidol university

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Bupivacaine · Dexamethasone

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