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

M

Mahidol University

Status and phase

Unknown
Phase 4

Conditions

Sciatic Nerve Block
Adductor Canal Block
Total Knee Arthroplasty

Treatments

Drug: bupivacaine and lidocaine
Device: Ultrasound
Drug: bupivacaine and dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT03486548
768/2560(EC1)

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

50 participants in 2 patient groups

control group
Sham Comparator group
Description:
adductor canal block with sham block
Treatment:
Drug: bupivacaine and lidocaine
Device: Ultrasound
sciatic group
Experimental group
Description:
adductor canal block with popliteal sciatic nerve block
Treatment:
Drug: bupivacaine and dexamethasone
Device: Ultrasound

Trial contacts and locations

1

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Central trial contact

Busara Sirivanasandha, MD

Data sourced from clinicaltrials.gov

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