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

Phase 4

• Conditions: Sciatic Nerve Block; Adductor Canal Block; Total Knee Arthroplasty
• Interventions: Drug: bupivacaine and lidocaine; Drug: bupivacaine and dexamethasone; Device: Ultrasound

• Registration Number: NCT03486548
• Lead Sponsor: Mahidol University

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2018-03
• Study First Submitted: 2018-03-15
• Study Start: 2018-04
• Study First Submitted QC: 2018-04-02
• Last Update Submitted: 2018-04-02
• Study First Posted: 2018-04-03
• Last Update Posted: 2018-04-03
• Primary Completion: 2019-02
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	bupivacaine and lidocaine	adductor canal block with sham block
sciatic group	bupivacaine and dexamethasone	adductor canal block with popliteal sciatic nerve block
sciatic group	Ultrasound	adductor canal block with popliteal sciatic nerve block
control group	Ultrasound	adductor canal block with sham block

Primary Outcome Measures

Name	Time	Method
postoperative pain score at rest	postoperative 24 hours	postoperative pain score at rest at 24 hour

Secondary Outcome Measures

Name	Time	Method
postoperative pain score at anterior and posterior site of knee	postoperative 24 hours	postoperative pain score at anterior and posterior site of knee at 24 hour
postoperative pain score on 45 degree knee flexion and physical therapy	postoperative 24 hours	postoperative pain score on 45 degree knee flexion and physical therapy
level of tibialis anterior muscle weakness	postoperative 24 hours	level of tibialis anterior muscle weakness in 24 hour
adverse events	postoperative 24 hours	perioperative adverse events such as LAST, hypotension, nausea and vomitting
total morphine consumption in postoperative 24 hours	postoperative 24 hours	total morphine consumption in postoperative 24 hours
patient satisfaction	postoperative 24 hours	patient satisfaction score
length of hospital stay	7 days	length of hospital stay

Trial Locations

Locations (1)

Siriraj Hospital, Mahidol University; 🇹🇭 Bangkoknoi, Bangkok, Thailand